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4-1-2022

Multimodal Nonopioid Pain Protocol Provides Better or Equivalent Multimodal Nonopioid Pain Protocol Provides Better or Equivalent

Pain Control Compared to Opioid Analgesia Following Pain Control Compared to Opioid Analgesia Following

Arthroscopic Rotator Cuff Surgery: A Prospective Randomized Arthroscopic Rotator Cuff Surgery: A Prospective Randomized

Controlled Trial. Controlled Trial.

Toufic R. Jildeh

Muhammad J. Abbas Henry Ford Health, [email protected]

Laith Hasan

Vasilios Moutzouros Henry Ford Health, [email protected]

Kelechi R. Okoroha

Follow this and additional works at: https://scholarlycommons.henryford.com/orthopaedics_articles

Recommended Citation Recommended Citation Jildeh TR, Abbas MJ, Hasan L, Moutzouros V, and Okoroha KR. Multimodal Nonopioid Pain Protocol Provides Better or Equivalent Pain Control Compared to Opioid Analgesia Following Arthroscopic Rotator Cuff Surgery: A Prospective Randomized Controlled Trial. Arthroscopy 2022; 38(4):1077-1085.

This Article is brought to you for free and open access by the Orthopedics / Bone and Joint Center at Henry Ford Health Scholarly Commons. It has been accepted for inclusion in Orthopedics Articles by an authorized administrator of Henry Ford Health Scholarly Commons.

Multimodal Nonopioid Pain Protocol Provides Better or Equivalent Pain Control Compared to Opioid Analgesia Following Arthroscopic Rotator Cuff

Surgery: A Prospective Randomized Controlled Trial Toufic R. Jildeh, M.D., Muhammad J. Abbas, B.S., Laith Hasan, B.S.,

Vasilios Moutzouros, M.D., and Kelechi R. Okoroha, M.D.

Purpose: To evaluate the efficacy of amultimodal nonopioid analgesic protocol in controlling postoperative pain compared to opioids following a primary arthroscopic rotator cuff repair. Methods: Seventy consecutive patients undergoing a pri- mary rotator cuff repair were assessed for eligibility. An observer-blinded prospective randomized controlled trial was designed in accordancewith theConsolidatedStandards ofReportingTrials 2010 (CONSORT) statement. The twoarmsof the study included a multimodal nonopioid pain regimen for the experimental group, and a standard of care narcotics for the control group. The primary outcomewas visual analog scale (VAS) pain scores for the first 10 postoperative days. Secondary outcomes included PROMIS-PI (Patient-Reported Outcomes Measurement Information System-Pain Interference) scale, patient satisfaction, and adverse drug events. Results: Thirty patients declined to participate or were excluded, and 40 patients were included in the final analysis. A total of 23 patients were in the traditional group, and 17 patients were in the nonopioid group. Control patients on opioid pain management reported a significantly higher VAS pain score on post- operative day 1 (opioid: 5.7� 2, nonopioid: 3.7� 2.2; P¼ .011) and postoperative day 4 (opioid: 4.4� 2.7, nonopioid: 2.4� 2.2;P¼ .023).No significant differencewas seenonanyotherpostoperative day.Whenmixedmeasuredmodelswereused to control for confounding factors, the nonopioid group demonstrated significantly lower VAS and PROMIS-PI scores (P< .01) at every time point. Patients in the traditional analgesia group reported significantly more days with constipation (P¼ .003) and days with upset stomach (P ¼ .020) than those in the nonopioid group. Concussion: The present study found that a multimodal nonopioid pain protocol provided equivalent or better pain control compared to traditional opioid analgesics in patients undergoing primary arthroscopic rotator cuff repair.Minimal side effects were notedwith some improvement in the multimodal nonopioid pain cohort. All patients reported satisfaction with their pain management. Level of Evidence: Level I, prospective randomized controlled trial.

See commentary on page 1086

Introduction

Postoperative pain management is an essential re- sponsibility of the orthopaedic surgeon. Physicians

have historically managed acute postoperative pain with the use of opioids; however, opioid misuse and over- prescription has been plaguing Americans.1 In 2017, the National Institutes of Health declared an opioid epidemic.2 Short-term exposure to narcotics post- operatively creates the risk for long-term misuse, abuse, and addiction in patients.3 In fact, previous studies have demonstrated thatmusculoskeletal conditions are one of the leading issues associated with the initial prescription of narcotics, inciting the addictive chain.4 In order to curtail the risk of narcotic abuse perioperatively, studies have characterized patient risk factors for prolonged postoperative opioid use.5,6 Further studies have sought

From the Steadman Philippon Research Institute, Vail, Colorado, U.S.A. (T.R.J.); Henry Ford Hospital, Department of Orthopaedic Surgery, Detroit, Michigan, U.S.A. (M.J.A., V.M.); Tulane University School of Medicine, New Orleans, Louisiana, U.S.A. (L.H.); and Mayo Clinic, Department of Ortho- pedic Surgery, Rochester, Minnesota, U.S.A. (K.R.O.).

The authors report the following potential conflicts of interest or sources of funding: V.M. reports travel and lodging support from Stryker and Smith & Nephew and educational support from Arthrex, outside the submitted work. T.R.J. reports educational support from Pinnacle, nonfinancial support from Exatech, outside the submitted work. K.R.O. reports educational support and hospitality payments from Arthrex, Smith & Nephew, and Zimmer, outside the submitted work. Full ICMJE author disclosure forms are available for this article online, as supplementary material.

Received August 4, 2021; accepted November 14, 2021. Address correspondence to Kelechi R. Okoroha, M.D., Mayo Clinic,

Department of Orthopedic Surgery, 600 Hennepin Ave., Suite 310, Minne- apolis, Minnesota, 55403, U.S.A. E-mail: [email protected]

� 2021 by the Arthroscopy Association of North America 0749-8063/211074/$36.00 https://doi.org/10.1016/j.arthro.2021.11.028

Arthroscopy: The Journal of Arthroscopic and Related Surgery, Vol 38, No 4 (April), 2022: pp 1077-1085 1077

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to assess the efficacy of nonopioid analgesics in the postoperative period.7,8 It is imperative that orthopaedic surgeons work to minimize the use of narcotics in the management of postoperative pain. Studies have demonstrated that 30% of patients over

the age of 60 experience rotator cuff tears, with that number rising to 62% over the age of 80.9 As the average age of Americans increases, the incidence of arthroscopic rotator cuff repair (RCR) in the United States is expected to experience a concomitant increase. Previous literature has sought to evaluate pain control following an arthroscopic RCR.7,10 In a cohort study, Moutzouros et al. used a nonopioid multimodal pain regimen consisting of an nonsteroidal anti- inflammatory drug (NSAID), acetaminophen, diaz- epam, and gabapentin following common orthopedic sports procedures and found that a multimodal pain regimen can provide effective pain control with a limited side effect profile.7 Magasaki et al. evaluated pain control following shoulder surgery and found that patients administered NSAIDs in combination with an intravenous patient-controlled analgesia (IV PCA) had

significantly lower opioid consumption postoperative compare to patients who received the IV PCA alone. These studies have demonstrated the value of multi- modal analgesic regimens in diminishing the post- operative opioid burden; however, to date, no study has eliminated the use of narcotics after rotator cuff repair. The purpose of this randomized controlled trial was to

evaluate the efficacy of a multimodal nonopioid anal- gesic protocol in controlling postoperative pain compared to opioids following a primary arthroscopic rotator cuff repair. The authors hypothesized that our nonopioid analgesic regimen would provide improved pain control with no significant difference in patient- reported adverse drug event between groups.

Methods This study was a prospective observer-blinded ran-

domized controlled trial with 2-week follow-up and was developed in accordance with the CONSORT (Consolidated Standards of Reporting Trials) statement (Fig 1).11 This investigation received institutional re- view board approval at our institution (IRB no. 12316)

Fig 1. CONSORT 2010 flow diagram.

1078 T. R. JILDEH ET AL.

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and was registered at ClinicalTrials.gov (NCT03818919). A hypothesis was formulated prior to trial initiation. Between August 2019 and December 2020, 70 consecutive patients who presented to two fellowship-trained sports surgeons and were scheduled to undergo a primary arthroscopic rotator cuff repair were screened for inclusion. Inclusion criteria required patients to be between the ages of 18 and 75 and scheduled for a primary arthroscopic RCR. Exclusion criteria included being non-English speaking, history of ipsilateral surgery in the previous year, undergoing revision surgery, use of blood thinner medication, his- tory of peptic ulcer disease, history of substance abuse, and intolerance or allergies to study medication. Following the surgical consult, patients consented to

participate in the study. Using an adaptive randomiza- tion software (MD Anderson Cancer Center, Houston, TX) with a 1:1 allocation, patients were randomized into the opioid or nonopioid cohort. A secure computer database was used to store all deidentified patient data. One week prior to the date of surgery, the project coordinator used a secure e-mail to inform the surgical staff of the patient’s group designation. Because of the fact that all outcomes would be self-reported by the patient, it was not necessary for the treating physician to be blinded. The research coordinator was not involved in patient care and performed patient enroll- ment and data collection.

Intervention All patients indeterminate of treatment group

received the following medication preoperatively: cel- ecoxib 400 mg, acetaminophen 975 mg, tramadol 50 mg, gabapentin 300 mg, and 8 mg dexamethasone intravenously. Arthroscopic RCR was performed under preoperative block. Intraoperatively, all patients received a local infiltration of 30 mg (1 mL) ketorolac, 1

mg (1 mL) epinephrine, and 150 mg (30 mL) of .5% ropivacaine. Using a 20-mL syringe and 22-gauge needle, local infiltrate was administered in 2-mL in- crements in the subcutaneous tissue around the portal sites. Patients who randomized into the control group were

prescribed 40 pills of 5 mg oxycodone. Patients were instructed to take 1-2 pills every 4-6 hours as needed (PRN) and told not to supplement their analgesia with ibuprofen or acetaminophen. Patients in the nonopioid group received a multi-

modal nonopioid analgesic regimen previously described in the literature.7 The protocol was developed to target various postoperative pain generators. Gaba- pentin was used to target neuropathic pain. Metho- carbamol was selected because of its excellent control of muscle spasms and cramps. Acetaminophen and NSAIDs (ketorolac and meloxicam) were used to target the pain cascade and the inflammatory process. Medi- cation dosage and frequency are listed in Table 1. Prior to discharge patients were instructed to call the

on-call physician regarding uncontrolled pain or adverse drug events postoperatively. Patients were provided an educational pamphlet describing the effects of narcotics, providing ways to manage pain, and treatment goals after surgery. All patients were dis- charged home the same day of surgery.

Outcomes The data collection was performed by blinded ob-

servers. Preoperatively, patients completed the Patient- Reported Outcomes Measurement and Information System Pain Interference Short Form (PROMIS PI-SF) questionnaire. Postoperatively, a mobile messaging- based outcomes collection software (Mosio, Inc, Seat- tle, WA) was used to collect patient-reported outcomes. Patients’ responses were submitted as numerical

Table 1. Multimodal Nonopioid Pain Regimen

Postoperative Days 1-5

Morning

- Ketorolac, 10 mg - Gabapentin*, 300 mg - Methocarbamol, 750 mg - Acetaminophen, 1000 mg

Noon

- Ketorolac, 10 mg - Gabapentin, 300 mg - Methocarbamol, 750 mg - Acetaminophen, 1,000 mg

Afternoon

- Ketorolac, 10 mg - Gabapentin, 300 mg - Methocarbamol, 750 mg - Acetaminophen, 1,000 mg

Evening

- Ketorolac, 10 mg - Methocarbamol, 750 mg

Postoperative Days 6-14

Morning

- Meloxicam, 7.5 mg - Methocarbamol, 750 mg - Acetaminophen, 1,000 mg

Afternoon

- Meloxicam, 7.5 mg - Methocarbamol, 750 mg - Acetaminophen, 1,000 mg

Evening

- Methocarbamol 750 mg - Acetaminophen 1,000 mg

Preoperative by mouth (PO) Regimen: PO celecoxib, 400 mg; acetaminophen, 975 mg; gabapentin, 300 mg; tramadol, 50 mg; dexamethasone, 8 mg iv. Intraoperative Local Infiltration Analgesia: 150 mg (30 mL) ropivacaine, 30 mg (1 mL) of ketorolac, and 1 mg (1 mL) of epinephrine *Gabapentin weaning began on postoperative day 6 in the following manner: 300 mg in the morning and 300 mg in the evening on days 6-7,

400 mg in the morning on days 8-9, and discontinuation on day 10.

NONOPIOID PROTOCOL AFTER ARTHROSCOPIC ROTATOR CUFF SURGERY 1079

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response via text message. This process allowed for the timely collection of data. Surveys were distributed to patients 3 times daily for 10 postoperative days. Patient-reported pain scores were collected using a

11-point visual analog scale 3 times a day; in the morning (9 AM), afternoon (1 PM), and evening (7 PM). Questions regarding adverse drug effects and the number of opioids consumed in the last 24-hour period (if applicable) were distributed each evening. Responses regarding the amount of opioid consumption daily was converted to morphine milligram equivalents (MME). During the first postoperative clinic visit (Postoperative days 7-10), patients completed the PROMIS-PI SF questionnaires. Information regarding the patients’ demographic data

(age, body mass index [BMI], race), anxiety/depression status, workers compensation, and previous opioid use was extracted from the electronic medical record.

Statistical Analysis A power analysis was performed prior to the initiation

of this investigation. Following a primary arthroscopic rotator cuff repair, previous literature has indicated that the minimal clinically significant difference (MCID) in VAS pain scores is 2.4 mm on a 10-mm scale.12 Addi- tionally, a previous case series demonstrated that the standard of deviation among VAS pain scores in pa- tients following an arthroscopic rotator cuff repair was 2.3 mm on a 10-point scale.7 With a power of 80% (b level ¼ .80, a level ¼ .05), effect size of 2.4 mm, and standard deviation of 2.3 mm; the minimum number of patients was 16 per cohort (n ¼ 32) to evaluate the primary outcome. Continuous variables are reported as means and

standard deviations, while frequency counts and per- centages are displayed for categorical variables. Com- parisons between the two pain control groups (traditional and nonopioid) are performed using chi- square tests, while Fisher’s exact test is used when ex- pected cell counts are <5. For continuous variables, two-group comparisons are performed using indepen- dent 2-sample t-tests if the variable is normally distributed and using Wilcoxon rank sum tests if the variable is non-normally distributed. Pearson correlation coefficients and their corre-

sponding P values are provided to show the correlation between select variables for the traditional pain control group, the nonopioid pain control group, and all patients. Repeated-measures analyses of variance were per-

formed using mixed models and included the effects of time, pain control group, and the interaction between time and pain control group as applicable. If needed, significant interaction effects were analyzed with post hoc comparisons using a Tukey-Kramer P value

correction. Predicted means of the outcome variables resulting from the models were plotted. Statistical sig- nificance is set at P < .05 for group comparisons and main effect testing. Significance is set at P < .10 for interaction testing. All analyses are performed using SAS 9.4 (SAS Institute, Inc., Cary, NC).

Results

Demographics Seventy consecutive patients with the primary diag-

nosis of rotator cuff tear were assessed for participation in the study. Thirty patients either declined to partici- pate or were excluded from the study. A total of 40 patients were included in the final analysis, and par- ticipants were randomized into 2 groups. Twenty-three patients were randomized to receive traditional opioid analgesia, and 17 were randomized to receive non- opioid analgesia. A total of 23 patients in the opioid group and 17 patients in the nonopioid group were included in the final analysis. All participants had an average age of 55.1 � 8.0 years old and an average BMI of 30.8 � 5.8. Twenty-five (56.8%) participants iden- tified as male, and 19 (43.1%) identified as female. Table 2 summarizes all demographic characteristics, preoperative block type, tear size, number of tendons

Table 2. Demographic Characteristics of Patients on Cohort

Traditional (n ¼ 23)

Nonopioid (n ¼ 17) P Value

Age (years) 55.9 � 7.2 53.7 � 9.1 .382 Sex Male 13 (56.5%) 9 (52.9%) .680 Female 10 (43.5%) 8 (47.1%)

BMI (kg/m2) 29.9 � 5.5 32.2 � 6.3 .218 Race White 14 (60.9%) 7 (41.2%) .238 AA 7 (30.4%) 8 (47.1%) Other 2 (8.7%) 2 (11.8%)

Preoperative Block Supraclavicular 5 (21.7%) 3 (17.6%) .758 Interscalene 18 (78.3%) 14 (82.4%)

Tear Size Less than 1 cm 4 (14.8%) 1 (5.8%) .777 1-3 cm 16 (69.6%) 11 (64.7%) 3-5 cm 2 (8.7%) 5 (29.4%) Greater than 5 cm 1 (4.3%) 0 (0%)

Tendons involved 1.4 � .8 1.7 � .4 .194 Concomitant Procedures None 2 (8.7%) 0 (0%) .479 Biceps tenotomy 2 (8.7%) 2 (11.8%) Biceps tenodesis 3 (48.3%) 4 (23.5%) DCE 2 (8.7%) 1 (5.9%) SAD 14 (60.9%) 10 (58.8%)

Anchors (mean � SD) 2.6 � 1.1 2.7 � .8 .770

Bold values denote statistical significance (P < .05). AA, African American; BMI, body mass index; DCE, distal clavicle

excision; SAD, subacromial decompression.

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involved and codominant procedures between the two cohorts. There were no workers compensation claims.

Traditional Versus Nonopioid Analgesia Patients in the traditional pain control group reported a

significantly higher VAS pain score on postoperative day 1 (opioid: 5.7� 2, nonopioid: 3.7� 2.2; P¼ .011, Fig 2) and postoperativeday4(opioid:4.4�2.7,nonopioid:2.4�2.2; P¼ .023). No significant difference was seen on any other postoperative day. There were no significant differences in PROMIS PI-SF scores between both groups preoperatively (opioid: 64.4� 4.2, nonopioid: 62.9� 4.3; P¼ .0291) and postoperatively (opioid: 60.0� 9.3, nonopioid: 59.3� 8.5; P ¼ .805). Following a repeated-measure, mixed-model analysis to assess covariates, the mean VAS score was significantly greater in the traditional group than in the nonopioid group across all postoperative days (P < .01) (Fig 3). Mixed-measures models also demonstrated that there was no significant difference in postoperative PROMIS-PI scores between cohorts (P¼ .49) (Fig 4). In the traditional pain control group, the highest opioid con- sumption, as reportedonpostoperativeday1-3 (POD1: 3.7 � 1.3 pills, 28.3� 9.1MME; POD 2: 3.4� 2.4 pills, 26.3� 17.7 MME; and POD 3: 2.8� 1.8 pills, 21.2 � 13.3 MME) and lowest on postoperative days 8-10 (POD8: 1.1 � 1.4 pills, 8.3� 10.9MME;POD9: .8� 1.2, 5.4� 8.8MME; and POD 10: 1.2� 1.7, 6.7 � 9.9 MME) (Fig 5). When evaluating all patients as a whole, patient

demographics (age, gender, BMI, and ethnicity) and

concomitant procedures did not have a statistically significant relationship with postoperative VAS scores or MME (P > .05).

Adverse Events Therewasno significant difference in thenumber of days

patients reported any adverse events (opioid: 4.1 � 3.5 days, nonopioid: 2.2 � 3.4 days; P ¼ .08). The most commonly reported side effects for patients in both groups were drowsiness (opioid: 2.7 � 3.3 days, nonopioid: 1.9� 3.3 days) and constipation (opioid: 2.2 � 2.9 days, non- opioid: .2 � .6 days). Patients in the traditional analgesia group reported significantly greater average number of days with constipation (opioid: 2.2 � 2.9, nonopioid: .2 � .6; P ¼ .003) and days with upset stomach (opioid: 1.3 � 2.5, nonopioid: .0 � .0; P ¼ .020) than those in the non- opioid group. Additionally, there was no significant differ- ence for nausea (P ¼ .06), diarrhea (P ¼ .46), drowsiness (P ¼ .33), or dizziness (P ¼ .68) between cohorts. Table 3 summarizes side effects for both cohorts. All (100%) pa- tients in the nonopioid protocol reported they were satis- fied with their pain management. There were no reported complicationswith thenonopioid protocol, andnopatients required emergency opioid analgesia.

Discussion The current study found that the multimodal non-

opioid analgesic protocol provided at least equivalent postoperative pain management with a similar or lesser

Fig 2. Average daily visual analog scale (VAS) pain score of patients of traditional and nonopioid pain regimen. *Values denote statistical significance (P < .05).

NONOPIOID PROTOCOL AFTER ARTHROSCOPIC ROTATOR CUFF SURGERY 1081

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side effect profile compared to traditional opioid anal- gesia. In conjunction with national efforts to reduce opioid addiction and consumption, the results suggest a multimodal nonopioid pain protocol may be an effec- tive alternative for postoperative pain management following arthroscopic RCR.

Reports of postoperative pain protocols successfully eliminating opioids have been promising but limited in the literature. Previous studies have suggested a po- tential benefit to postoperative nonopioid pain man- agement, including alternatives such as NSAIDs, gabapentin, cryotherapy, local anesthesia injections,

Fig 3. Mean hourly pain data con- trolling for age, graft, body mass in- dex, sex, smoking, and depression comparing daily pain levels between the two groups. The mean visual analog scale (VAS) score is signifi- cantly greater in the traditional group than in the nonopioid group (P < .01).

Fig 4. PROMIS PI-SF (Patient-Re- ported Outcomes Measurement In- formation System-Pain Interference- Short Form) controlling for age, sex, body mass index, smoking, and depression. No significant difference in PROMIS PI was found between the two groups (P ¼ .49).

1082 T. R. JILDEH ET AL.

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and nerve blocks.13 A randomized control trial by Syed et al. demonstrated opioid-related preoperative educa- tion alone significantly reduced opioid consumption at 6 weeks (P ¼ .02) and 3 months (P ¼ .01) after arthroscopic RCR.14,15 In a randomized control trial investigating the addition of liposomal bupivacaine in- jection to multimodal anesthetic protocols in primary RCR, Sethi et al. found a significant reduction in post- operative pain in days 1 (P < .001) and 2 (P ¼ .03) and the number of opioids used in the first 5 days after arthroscopic RCR (P ¼ .003) compared to the control group.16 In a prospective study of 36 patients investi- gating the use of ketorolac, zolpidem, and acetamino- phen as an alternative to opioids following RCR, Theosmy et al. found that 67% of patients successfully completed opioid-free arthroscopic RCR.17 They also found that patients who did not take opioids post- operatively demonstrated higher satisfaction with their

pain management. Finally, in a case series by Mout- zouros et al. of 141 patients (27 RCR) using an identical nonopioid pain protocol to the current study, they found that 45% of all patients did not require any breakthrough opioids, and the average VAS pain score at 1 week postoperatively was 3.9 � 2.8 following RCR.7 In accordance with previous literature, the pre- sent study demonstrates that equivalent pain control postoperative as reported by VAS pain scores. Addi- tionally, patients in the nonopioid group reported a statistically significant decrease in VAS scores when controlling for confounding variables. All patients in the present study reported 100% satisfaction with their respective pain control regimens, highlighting that postoperative pain control and patient satisfaction can be achieved while minimizing the risk of opioid addi- tion postoperatively. When deciding on a postoperative pain regiment, it is

essential to consider how to best maximize therapeutic benefit while minimizing adverse events and side ef- fects for patients. Opioids have a broad side effect pro- file, most commonly, including drowsiness, gastrointestinal issues, such as constipation and nausea, and vomiting.18 In a survey of 500 patients assessing their perception of treatment with opioids, respondents reported nausea (78%) and constipation (64%) as the most common causes for discontinuing opioids.19 In a prior case series using a nonopioid analgesia protocol, Moutzouros et al. found that 53.6% of patients re- ported no adverse effects of their pain regimen, with the most commonly reported side effects in both groups

Fig 5. Predicted mean MME for opioid group when controlling for age, sex, body mass index, smoking, and depression. Morphine equiva- lent usage was found to decrease as time from surgery increased (specif- ically, from sequential day to day). Time was found to be a significant factor (P < .0001). MME, morphine milligram equivalents.

Table 3. Average Number of Days Side Effects Were Reported in the Traditional and Nonopioid Pain Protocol

Traditional (n ¼ 23)

Nonopioid (n ¼ 17) P Value

Total constipated days 2.2 � 2.9 .2 � .6 .003 Total nausea days 1.0 � 1.6 .1 �.3 .066 Total diarrhea days .1 � .2 .0 � .0 .457 Total upset stomach days 1.3 � 2.5 .0 � .0 .020 Total drowsiness days 2.7 � 3.3 1.9 � 3.3 .327 Total dizziness days .4 � 1.0 .2 � .4 .681

Values are expressed as mean days � SD. Bold values denote sta- tistical significance (P < .05).

NONOPIOID PROTOCOL AFTER ARTHROSCOPIC ROTATOR CUFF SURGERY 1083

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being constipation (opioid: 1.9 � 2.9; nonopioid: .9 � 2.0) and drowsiness (opioid: 2.5 � 3.6; nonopioid: 1.0 � 1.6).7 The current study demonstrated that the multimodal analgesia cohort had significantly fewer total constipated days and upset stomach days than the traditional opioid analgesia cohort, suggesting improved gastrointestinal side effect experiences for patients with no compromise on pain control. The current study also demonstrated a nonsignificant decrease in total nausea days (1.0 in the opioid cohort vs .1 in the nonopioid cohort). Opioid medications are a well-known source of sedation and drowsiness in pa- tients.20 Dizziness or drowsiness may also be caused by methocarbamol and gabapentin; however a random- ized controlled trial investigating gabapentin use following shoulder arthroscopy demonstrated that the use of gabapentin had no significant differences in somnolence-dizziness and nausea-vomiting and increased patient satisfaction.21-23 While the multi- modal pain control regimen may present concerns regarding the use of NSAIDs and tendon to bone healing, a meta-analysis by Duchman et al. demon- strated that there is not sufficient evidence in the literature supporting the avoidance of NSAIDs following acute injury or surgical repair of the tendon- bone interface; however, this is an area that warrants further investigation.24

Previous literature has assessed pain control and MME levels and its correlation with demographic characteristics and concomitant procedures. In a retro- spective analysis investigating chronic opioid use following surgery, Sun et al. found that preoperative history of drug or alcohol abuse, depression, benzodi- azepine use, or antidepressant use were associated with chronic opioid consumption postoperatively.25 Addi- tionally, Sun et al. also found that men were associated with chronic opioid use following surgery. In a cohort study examining factors that predicted the severity of postoperative pain after RCR surgery Rizvi et al. found that tendon tear size was inversely related with pain severity (R2 ¼ .85). Additionally, they demonstrated that other factors associated with postoperative pain frequency included work-related injury status (P < .001), younger age (P ¼ .001), and female sex (P ¼ .04). The current study revealed no correlation between gender, concomitant procedures, and VAS scores, and no association with tendon tear size. Since pain perception and tolerance may be influenced by a wide range of factors, this area warrants further investigation to provide the most effective pain management for patients.

Limitations This study is not without limitations. Because of the

study design, double blinding was not possible, since patients were informed of their postoperative

treatment. Consequently, this made bias in patient- reported pain scores possible. Furthermore, we were unable to measure patient compliance with medication, which may have further influenced pain scores as pa- tients could opt to not take their medication. Addi- tionally, this study was only powered to assess the primary outcome of VAS scores postoperatively. The sample size was not large enough to perform a comprehensive subgroup analysis for all demographic characteristics and concomitant procedures. A high number of patients declined to participate because of the predetermined preferences for postoperative anal- gesia. These patients did not want to risk randomization and not receiving their desired pain regimen. Although this may have impacted the study group, it is important to note that it was not possible to blind patients to their medication, particularly when evaluating side effect profile of each regimen. Finally, it was not possible to evaluate the total pain reduction possible with the nonopioid pain regimen, as it would be unethical to withhold pain medication from patients following surgery.

Conclusion The present study found that a multimodal nonopioid

pain protocol provided equivalent or better pain control compared to traditional opioid analgesics in patients un- dergoing primary arthroscopic rotator cuff repair. Mini- mal side effects were noted with some improvement in the multimodal nonopioid pain cohort, and all patients reported satisfaction with their pain management.

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