Rotator Cuff Pathway

The Association Between a Comprehensive Multimodal Pathway And Pain 0-48 Hours After Arthroscopic Rotator Cuff Repair: A Before-and After Study

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. The specific aim is to determine whether a comprehensive pathway that includes a well-defined regional technique and multimodal analgesia will reduce the worst pain with movement 0-48 hours after block placement compared to the current standard practice. This is a 'before and after' study. We plan to have 70 patients studied prior to initiation of a pathway, and 70 patients studied after initiation of a pathway. Both groups will receive identical postoperative follow-up.

Study Overview

• Status: Completed
• Conditions: Shoulder Pain
• Intervention / Treatment: Other: Pathway

Detailed Description

Previous study in shoulder arthroplasty patients demonstrated low pain scores and minimal intravenous opioid use when utilizing a clinical pathway that included peripheral nerve block and preemptive non-opioid analgesia (Goon et al. 2014). These surgeries were done as inpatient and patients had availability of intravenous opioids. Assessment of the current approach to managing rotator cuff repairs demonstrated an average worst pain score after surgery of 7.0, SD 2.1 (Kahn) which is often categorized as "severe" pain. Given that most rotator cuff repairs are done as outpatients, it is important to develop a clinical pathway that mitigates the worst pain experienced after surgery. With outpatient surgery, there are obvious limitations regarding availability of rescue pain medications. Therefore, the pathway needs to emphasize patient education and strategies to reduce the pain as peripheral nerve block subsides. Given these issues, we believe there is an advantage to prolonging the analgesia from the nerve block (Rosenfeld et al. 2016, Yadeau et al. 2016, Kahn) and educating patients regarding the importance of preemptive analgesia and when to take opioid medications. This study will evaluate whether the clinical pathway might mitigate the worst pain after surgery that occurs with the current standard practice.

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Hospital of Special Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Before Group; We plan to have 70 patients studied prior to initiation of a pathway.
Experimental: After Group; We plan to have 70 patients studied after initiation of a pathway.	Other: Pathway; The study team emphasizes that all components of the pathway are considered standard of care at this institution. The objective of this study is to ensure that the study patients assigned to the pathway will receive these standard of care components. Both groups will receive identical postoperative follow-up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Outcome - Worst NRS With Movement	worst NRS with movement. A lower score is a better outcome. The score range is between 0 and 10.	0-48 hours after block placement

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Score at Rest	a NRS score on a scale from 0 to 10. 0 means no pain and 10 is the worst pain imaginable. A lower score is a better outcome.	Post Op Days 1,2,7,14
Total Opioid Use	The total opioid consumption measured in morphine milligram equivalents (MME). Although recorded at different time points, the total MME per patient was calculated.	Post Op Days 1,2,7,14
Patient Satisfaction With Pain Management	Measures the patient's satisfaction with their pain management on a scale of 0-10. A higher score is a better outcome.	Post Op Days 1,2,7,14
Block Duration	Measures the duration of the block from: the time the block started to the time the block completely wore off the time the block started to the time the patient first noticed pain the time the block started to the time the patient felt normal sensation	Through Post Op Day 2

Collaborators and Investigators

• Sponsor: Hospital for Special Surgery, New York
• Investigators: Principal Investigator: Jacques YaDeau, Hospital for Special Surgery, New York

Publications and helpful links

General Publications

• YaDeau JT, Soffin EM, Tseng A, Zhong H, Dines DM, Dines JS, Gordon MA, Lee BH, Kumar K, Kahn RL, Kirksey MA, Schweitzer AA, Gulotta LV. A Comprehensive Enhanced Recovery Pathway for Rotator Cuff Surgery Reduces Pain, Opioid Use, and Side Effects. Clin Orthop Relat Res. 2021 Aug 1;479(8):1740-1751. doi: 10.1097/CORR.0000000000001684.

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2018
• Primary Completion (Actual): January 26, 2020
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: September 12, 2018
• First Submitted That Met QC Criteria: October 23, 2018
• First Posted (Actual): October 24, 2018

Study Record Updates

• Last Update Posted (Actual): October 3, 2023
• Last Update Submitted That Met QC Criteria: September 14, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Shoulder Pain
• Other Study ID Numbers: 2018-0814 (Other Identifier: Institutional Review Board)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No