Rotator Cuff Pathway

Shoulder Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03717753
• Other study ID #: 2018-0814
• Status: Completed
• Phase: N/A
• Start date: September 7, 2018
• Est. completion date: March 1, 2020

Study information

• Verified date: September 2023
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: March 1, 2020
• Est. primary completion date: January 26, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Shoulder Pain

Intervention

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.

Locations

Country	Name	City	State
United States	Hospital of Special Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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