Rotator Cuff Pathway

NCT03717753 | Completed Results

• 1 other identifier: 2018-0814
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Total Opioid Use

  Post Op Days 1,2,7,14

• Patient Satisfaction With Pain Management

  Post Op Days 1,2,7,14

• Pain Score at Rest

  Post Op Days 1,2,7,14

• Block Duration

  Through Post Op Day 2

Study Arms (2)

Before Group

NO INTERVENTION

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

After Group

EXPERIMENTAL

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

Other: Pathway

Interventions

Pathway 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.

After Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital of Special Surgery

New York, New York, 10021, United States

Location

Related Publications (1)

• 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.

  PMID: 33720071 DERIVED

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Jacques YaDeau, MD PhD
• Organization: Hospital for Special Surgery

yadeauj@hss.edu

212- 606-1206

Study Officials

• Jacques YaDeau

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2018
• First Posted: October 24, 2018
• Study Start: September 7, 2018
• Primary Completion: January 26, 2020
• Study Completion: March 1, 2020
• Last Updated: December 27, 2024
• Results First Posted: January 11, 2023

Record last verified: 2024-12

Locations

US (1)