The Association Between a Comprehensive Multimodal Pathway And Pain 0-48 Hours After Arthroscopic Rotator Cuff Repair: A Before-and After Study
Phase: NA
Conditions: Shoulder Pain
Sponsor: Hospital for Special Surgery, New York

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The Association Between a Comprehensive Multimodal Pathway And Pain 0-48 Hours After 
Arthroscopic Rotator Cuff Repair: A Before-and After Study 
 
FUNDER: Research & Education Fund, Department of 
Anesthesiology, Critical Care & Pain 
Management 
PROTOCOL NO.: 2018-0814 
VERSION & DATE: 8/22/2018 
 
 
 
 
 
 
 
 
 
 
 
 
This document contains the confidential information of the Hospital for Special Surgery.  It is 
provided to you and your company’s personnel for review.  Your acceptance of this document 

 
  
 
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constitutes an agreement that you will not disclose the information contained herein to others 
without the prior written consent of the Hospital for Special Surgery.  No other use or 
reproduction is authorized by Hospital for Special Surgery, nor does the Hospital for Special 
Surgery assume any responsibility for unauthorized use of this protocol 
PROTOCOL SYNOPSIS 
Protocol Title: 
The Association Between a Comprehensive Multimodal 
Pathway And Pain 0-48 Hours After Arthroscopic Rotator Cuff 
Repair: A Before-and After Study 
Protocol Number: 
2018-0814 
Protocol Date: 
8/22/2018 
Sponsor: 
N/A 
Principal 
Investigator: 
Jacques T YaDeau, MD PhD 
Products: 
NA 
Objective: 
The specific aim is to determine whether a comprehensive 
pathway that includes a well-defined regional technique and 
multimodal analgesia (scheduled NSAID, acetaminophen, 
gabapentin) will reduce the worst pain with movement 0-48 
hours after block placement compared to the current standard 
practice 
Study Design: 
Before and After Observational Study 
Enrollment: 
140 
Subject Criteria: 
Ambulatory rotator cuff patients with participating surgeons. 
 
Includes the following concomitant procedures: 
Arthroscopic SLAP (Superior Labrum Anterior and Posterior) 
repair 
Arthroscopic Stabilization 
Arthroscopic AC (Acromioclavicular) resection 
Arthroscopic SAD (Sub-Acromial Decompression) 
Arthroscopic or mini open biceps tenodesis 
 
Age 18-80 
Study Duration: 
September 2018 – January 2020  
Data Collection: 
 
Name 
 
MRN ID 
 
Age 
 
Race 
 
Ethnicity 

 
  
 
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 
Gender 
 
Height 
 
Weight 
 
BMI 
 
ASA 
 
NRS Pain scores at rest and with movement 
 
PainOUT questionnaire 
 
Nerve Block Success 
 
Use of Multimodal Analgesia 
 
Extent of Surgery 
 
Sleep Interference 
 
Postoperative Complications 
Outcome 
Parameters: 
 
The primary outcome is the worst NRS pain score with 
movement from 0 – 48 hours after block placement. 
1. Total opioid use (POD 0, 1, 2, 7, 14) 
2. Pain scores at additional timepoints (Preop, POD 0, 1, 
2, 7, 14) 
3. Patient-oriented pain questionnaire (PainOUT) (POD1, 
2) 
4. Block duration (POD2, 7) 
5. Satisfaction with pain management (POD 7) 
6. Patient and physician adherence to the pathway (POD 
0, 1, 2, 7, 14) 

 
  
 
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Statistical Analysis: 
Proposed sample size analysis, include the following: 
Student's t-test, ANOVA, chi-square, regression, etc; 
Alpha level; Beta or power level; Primary outcome variable 
estimate (mean +/-s.d. for continuous outcome, 
frequency/percentage for categorical variable); Number of 
groups being compared (use 1 for paired analysis within the 
same subjects); Effect size or change expected between 
groups; Resulting number per group 
 
1. Proposed analysis (e.g., student’s t-test, ANOVA, chi-square, 
regression, etc.): Multivariable linear regression 
2. Interim analysis planned? No 
3. Alpha level: 0.05 
4. Beta or power level: 80% 
5. Primary outcome variable estimate (mean +/- s.d. for 
continuous 
outcome, frequency/percentage for categorical variable): Mean 
± SD worst NRS pain score with movement 24-48 hours post 
rotator cuff repair: 7.0 ± 2.1 à 7.0 ± 2.4 (Kahn 2018) 
6. Number of groups being compared (use 1 for paired analysis 
within the same subjects):2 
7. Effect size or change expected between groups: 1.3 (Todd 
1996) 
8. Resulting number per group: 58 
9. Total sample size required: 116 + 20% to account for protocol 
violations and/or missing data = 140 
 
Based on Harrell (2015), a minimum of 15 patients per predictor 
is suggested for a multivariable linear regression model. 116 
patients would provide approximately 19 patients per each of 6 
predictors (i.e., before vs. after pathway implementation, 
preoperative worst NRS pain score with movement over past 24 
hours, boney work (yes vs. no), age, sex, and BMI). 
 
References 
Kahn, RL, et al. Perineural Low Dose Dexamethasone Prolongs 
Inter-Scalene Block Analgesia with Bupivacaine Compared to 
Systemic Dexamethasone: A Randomized Trial. (Accepted to 
RAPM) 
Todd KH, Funk KG, Funk JP, et al. Clinical significance of 
reported changes in pain severity. Ann Emerg Med 1996; 27(4): 
485–489 
Harrell, FE. Regression Modeling Strategies, with Applications 
to Linear Models, Logistic and Ordinal Regression, and Survival 
Analysis, second edition ed. New York: Springer, 2015. 
 
 
 

 
  
 
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1.0 INTRODUCTION 
Rotator cuff surgery is mostly performed on an outpatient basis, and many patients still 
experience moderate to severe pain after surgery, despite the use of regional anesthesia 
and opioids. Among shoulder surgery patients receiving long-acting nerve blocks, the worst 
pain typically coincides with recession of peripheral nerve blockade. Interscalene nerve 
block is an effective regional anesthesia technique that involves injection of local anesthetic 
near the brachial plexus resulting in excellent postoperative analgesia (Hadzic et al. 2005, 
Kinnard et al. 1994). As the sensory blockade wears off, however, it is not uncommon for 
patients to experience moderate to severe pain and report high pain scores after surgery 
(Cheng et al. 2013, Gadsden et al. 2011). There is also considerable variability in 
anesthesiologists’ practice with regard to regional techniques, intraoperative management, 
and patient education that can influence postoperative analgesia. 
 
Pain control after surgery has a number of important implications. Adequate analgesia 
improves patient satisfaction and facilitates the process of rehabilitation. On the other hand, 
uncontrolled pain is a common cause of distress and unplanned emergency department and 
urgent care visits (Navarro et al. 2018). Furthermore, patients with poorly controlled acute 
pain are at risk for developing chronic pain. 
 
Clinical pathways are based on the concept of a multimodal approach to improving recovery 
after surgery (Kehlet et al. 1997). These pathways emphasize the importance of patient 
education and using multiple approaches to treating postoperative pain rather than relying 
on a single modality or technique of analgesia (White et al. 2005).  These principles have 
been applied for total shoulder arthroplasty and demonstrated low pain scores after surgery 
(Goon et al. 2014). The aim of this study is to evaluate pain outcomes with arthroscopic 
rotator cuff surgery after implementing a clinical pathway that incorporates patient 
education, long-acting nerve block, and preemptive multimodal analgesia. Worst pain is 
chosen as the primary outcome because it is a well-validated endpoint for evaluating a pain-
reduction treatment effect (Atkinson et al. 2010, Mendoza et al. 2006), and it has been used 
in prior investigations (Vandepitte et al. 2017). 
 
Atkinson T, Mendoza T, et al. The Brief Pain Inventory and its “Pain at its Worst in the last 
24 Hours” Item: Clinical Trial Endpoint Considerations. Pain Med. 2010 March; 11(3): 337-
346 
 
Cheng J, Kahn R, YaDeau JT, et al. The fibromyalgia survey score correlates with 
preoperative pain phenotypes but does not predict pain outcomes after shoulder 
arthroscopy. Clin J Pain. 2016 August; 32(8):689-94. 
Gadsden J, Hadzic A, Gandhi K, et al. The effect of mixing 1.5% mepivacaine and 0.5% 
bupivacaine on duration of analgesia and latency of block onset in ultrasound-guided 
interscalene block. Anesth Analg. 2011; 112:471-6. 
Goon Ak, Dines DM, Craig EV, et al. A clinical pathway for total shoulder arthroplasty – a 
pilot study. HSS J. 2014 July; 10(2):100-6 
 
Hadzic A,Williams BA, Karaca PE, et al. For outpatient rotator cuff surgery, nerve block 
anesthesia provides superior same-day recovery over general anesthesia. Anesthesiology. 
2005; 102: 1001-1007. 
 

 
  
 
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Kehlet, H. Multimodal approach to control postoperative pathophysiology and rehabilitation. 
Br. J Anaesth 1997; 78(5):606-17.  
 
Kinnard P, Truchon R, St-Pierre A, Montreuil J. Interscalene block for pain relief after 
shoulder surgery. A prospective randomized study. Clin Orthop Relat Res. 1994; 304: 22-
24. 
 
Mendoza T, Mayne T, et al. Reliability and validity of a modified Brief Pain Inventory short 
form in patients with osteoarthritis. Eur J Pain. 2006 May; 10(4): 353-61 
 
Navarro RA, Lin CC, Foroohar A, et al. Unplanned emergency department or urgent care 
visits after outpatient rotator cuff repair: potential for avoidance. J Shoulder Elbow Surg. 
2018 Jan; pii: S1058-2746(17)30830-3. doi: 10.1016/j.jse.2017.12.011. [Epub ahead of 
print] 
 
Vandepitte C, Kuroda M, et al. Addition of Liposome Bupivacaine to Bupivacaine HCl 
Versus Bupivacaine HCl Alone for Interscalene Brachial Plexus Block in Patients Having 
Major Shoulder Surgery. Reg Anesth Pain Med. 2017 May/Jun; 42(3): 334-341 
 
White PF. The changing role of non-opioid analgesic techniques in the management of 
postoperative pain. Anesth Analg. 2005; 101: S5-S22. 
2.0 PRODUCT DESCRIPTION 
N/A 
3.0 OBJECTIVE OF CLINICAL STUDY 
The specific aim is to determine whether a comprehensive pathway that includes a well-
defined regional technique and multi-modal analgesia (scheduled NSAID, acetaminophen, 
gabapentin) will reduce the worst pain with movement0-48 hours after block placement 
compared to the current standard practice. 
4.0 STUDY HYPOTHESES 
Use of a comprehensive multimodal pathway will reduce the worst pain with movement after 
arthroscopic rotator cuff surgery (0 to 48 hours after block placement) compared to the 
current standard practice. 
5.0 STUDY DESIGN 
 
5.1 
Study Duration 
9/2018-1/2020 
5.2 
Endpoints 
 

 
  
 
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5.2.1 Primary Endpoint 
The primary outcome is the worst NRS pain score with movement from 0 – 48 
hours after block placement. 
5.2.2 Secondary Endpoints 
1. Total opioid use (POD 0, 1, 2, 7, 14) 
2. Pain scores at additional timepoints (Preop, POD 0, 1, 2, 7, 14) 
3. Patient-oriented pain questionnaire (PainOUT) (POD1, 2) 
4. Block duration (POD2, 7) 
5. Satisfaction with pain management (POD 7) 
6. Patient and physician adherence to the pathway (POD 0, 1, 2, 7, 14) 
5.3 
Study Sites 
Hospital for Special Surgery – Main Campus 
6.0 STUDY POPULATION 
6.1 
Number of Subjects 
 
140 
6.2 
Inclusion Criteria 
Ambulatory rotator cuff patients with participating surgeons; Age 18-80 
 
Includes the following concomitant procedures: 
Arthroscopic SLAP (Superior Labrum Anterior and Posterior) repair 
Arthroscopic Stabilization 
Arthroscopic AC (Acromioclavicular) resection 
Arthroscopic SAD (Sub-Acromial Decompression) 
Arthroscopic or mini open biceps tenodesis 
 
6.3 
Exclusion Criteria 
Subjects will be excluded from the study if they: 
 
chronic pain history (defined as use of opioids > 3 months or current gabapentinoids 
for pain) 
 
open surgery (but sub pectoralis mini open biceps tenodesis is not excluded) 
 
revision surgery 
 
kidney disease (GFR < 60 ml/min/1.73 m2 for 3 months or more) 
 
liver disease (transaminitis, cirrhosis, hepatitis, hypoalbuminemia, coagulopathy) 
 
planned avoidance of regional anesthesia 
 
any contraindication to or patient refusal of any component in the pathway 
 
Non-English speakers 
6.4 
Randomization 
The study does not involve randomization.  

 
  
 
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7.0 PROCEDURES 
7.1 
Surgical Procedure 
Ambulatory rotator cuff patients with participating surgeons;  
 
Includes the following concomitant procedures: 
Arthroscopic SLAP (Superior Labrum Anterior and Posterior) repair 
Arthroscopic Stabilization 
Arthroscopic AC (Acromioclavicular) resection 
Arthroscopic SAD (Sub-Acromial Decompression) 
Arthroscopic or mini open biceps tenodesis 
 
7.1.1 Investigational Product Application 
N/A 
 
7.2 
Data Collection 
 
Data will be collected by an investigator or research assistant. Sources of data include 
medical records and patient physical assessments conducted by study personnel. Data will 
be recorded and managed using REDCap electronic data capture tools hosted at the 
Clinical and Translational Science Center (CTSC) at Weill Cornell Medical College. 
REDCap (Research Electronic Data Capture) is a secure, web-based application designed 
to support data capture for research studies, providing: 1) an intuitive interface for validated 
data entry; 2) audit trails for tracking data manipulation and export procedures; 3) automated 
export procedures for seamless data downloads to common statistical packages; and 4) 
procedures for importing data from external sources. Connection to REDCap occurs via the 
hospital’s encrypted cable and wireless networks, and data will be entered through a 
password-protected computer terminal or iPad.   

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7.3 
Schedule of Assessments 
 
Study 
Visit # 
Surveys / 
Questionnaires 
Surgery Anesthesia 
Pain 
Management 
Phone 
Contacts 
Day of 
Surgery 
RES 
SOC 
SOC 
SOC 
 
Day 1 
after 
surgery 
RES 
 
 
SOC 
RES 
Day 2 
after 
surgery 
RES 
 
 
SOC 
RES 
Day 7 
after 
surgery 
RES 
 
 
SOC 
RES 
Day 14 
after 
surgery 
RES 
 
 
SOC 
RES 
 
 
RES= Research Procedures 
SOC= Standard of care (care you would receive if you were not participating in this study) 

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8.0 STATISTICAL ANALYSIS 
Proposed sample size analysis, include the following: 
Student's t-test, ANOVA, chi-square, regression, etc; Alpha level; Beta or power level; 
Primary outcome variable estimate (mean +/-s.d. for continuous outcome, 
frequency/percentage for categorical variable); Number of groups being compared (use 1 for 
paired analysis within the same subjects); Effect size or change expected between groups; 
Resulting number per group 
 
1. Proposed analysis (e.g., student’s t-test, ANOVA, chi-square, 
regression, etc.): Multivariable linear regression 
2. Interim analysis planned? No 
3. Alpha level: 0.05 
4. Beta or power level: 80% 
5. Primary outcome variable estimate (mean +/- s.d. for continuous 
outcome, frequency/percentage for categorical variable): Mean ± SD worst NRS pain score 
with movement 24-48 hours post rotator cuff repair: 7.0 ± 2.1 à 7.0 ± 2.4 (Kahn 2018) 
6. Number of groups being compared (use 1 for paired analysis within the same subjects):2 
7. Effect size or change expected between groups: 1.3 (Todd 1996) 
8. Resulting number per group: 58 
9. Total sample size required: 116 + 20% to account for protocol violations and/or missing 
data = 140 
 
Based on Harrell (2015), a minimum of 15 patients per predictor is suggested for a 
multivariable linear regression model. 116 patients would provide approximately 19 patients 
per each of 6 predictors (i.e., before vs. after pathway implementation, preoperative worst 
NRS pain score with movement over past 24 hours, boney work (yes vs. no), age, sex, and 
BMI). 
 
References: 
Kahn, RL, et al. Perineural Low Dose Dexamethasone Prolongs Inter-Scalene Block 
Analgesia with Bupivacaine Compared to Systemic Dexamethasone: A Randomized Trial. 
(Accepted to RAPM) 
Todd KH, Funk KG, Funk JP, et al. Clinical significance of reported changes in pain severity. 
Ann Emerg Med 1996; 27(4): 485–489 
Harrell, FE. Regression Modeling Strategies, with Applications to Linear Models, Logistic 
and Ordinal Regression, and Survival Analysis, second edition ed. New York: Springer, 
2015. 
 
ADVERSE EVENT ASSESSMENT 
All Adverse Events (AEs) will be reported in the final study report. Definitions for Adverse 
Event (AE) used in this study are listed below and are based on FDA and international 
guidelines: 
 
8.1 
Adverse Event (AE) 
Participation in this research involves the potential risk of a break of confidentiality to 
stored health information. HSS tries to minimize those risks by (i) removing some 
direct identifiers from stored information (i.e., names, social security numbers, 

 
  
 
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medical record numbers); (ii) securing, in a separate location, and limiting access to 
information that would be identifiable; and (iii) limiting access to information stored to 
HSS investigators. 
The likelihood of a breach of confidentiality is minimal. 
8.2 
Serious Adverse Events (SAE) 
N/A 
8.3 
Subsequent Surgical Interventions Definitions 
N/A 
8.4 
Adverse Event Reporting 
All adverse events will be reported to the DSMB and IRB within five working days of 
the event. 
9.0 INVESTIGATOR RESPONSIBILITIES, RECORD AND REPORTS 
 
9.1 
Subject Consent and Information 
Written/signed consent will be collected from participants in the holding area before surgery. 
 
9.2 
Subject Data Protection 
o HSS tries to minimize those risks by (i) removing some direct identifiers from 
information stored [(i.e., names, social security numbers, medical record 
numbers)]; (ii) securing, in a separate location, and limiting access to information 
linking codes (i.e., linkage codes) assigned to the registry information with direct 
participant identifiers; and (iii) limiting access to information stored to HSS 
investigators.  
o Access to the REDCap program is password-protected, and access to a specific 
study's information within the program is limited to the research assistant and 
other IRB-approved study personnel who have been given permission to view 
and/or enter study data. REDCap program access is authorized by the CTSC; 
particular study access is granted by the research assistant. For data exports, 
fields marked as protected health information (PHI) in REDCap will be de-
identified, if feasible. 
o All transmission of data will occur via encrypted networks in password-protected 
files. Any paper-based data sheets utilized for the study will have personal 
identifiers removed whenever possible and will be stored in the department's 
locked office. Each subject will be assigned a unique study number for 
identification, and that number will not be derived from or related to information 
about the individual. Presentations and publications that result from this study will 
not contain any individual identifiers (at most the unique study numbers may be 

 
  
 
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referred to). Thus our research presents a minimal risk of harm to subjects' 
privacy. 
 
 

 
  
 
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