Rotator Cuff Pathway

NCT ID: NCT03717753

Last Updated: 2024-12-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-07
• Study Completion Date: 2020-03-01

Brief 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.

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.

Conditions

Shoulder Pain

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Before Group

We plan to have 70 patients studied prior to initiation of a pathway.

Group Type: NO_INTERVENTION

No interventions assigned to this group

After Group

We plan to have 70 patients studied after initiation of a pathway.

Group Type: EXPERIMENTAL

Pathway

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital for Special Surgery, New York

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacques YaDeau

Role: PRINCIPAL_INVESTIGATOR

Hospital for Special Surgery, New York

Locations

Hospital of Special Surgery

New York, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33720071 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2018-0814

Identifier Type: -

Identifier Source: org_study_id