Nonopioid Analgesia After Rotator Cuff Repair

NCT03818919 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 123191
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, single blinded, standard of care controlled clinical trial. This project aims to compare postoperative pain control in patients in two treatment arms of rotator cuff repair: a treatment group given a nonopioid pain control regimen, and a standard of care control group given standard opioid pain control regimen

Conditions

Rotator Cuff Tear

Outcome Measures

Primary Outcomes (2)

• Pain Levels

  Patients record pain levels using Visual analog scales for 10 days post-operatively. The visual analog scale ranges from 0 (no pain) to 10 (worst pain). Average daily pain was calculated for each patient. Higher values portend worse control.

  day 10 post-operative

• Patient-Reported Outcomes Measurement Information System

  Patient-Reported Outcomes Measurement Information System Pain Interference (PROMIS PI) for 10 days post-operatively. PROMIS-PI scale ranges from 0 (no pain interference ) to 100 (most pain interference). Average PROMIS PI values were calculated. A higher score indicates more pain interference.

  day 10 post-operative

Study Arms (2)

Post-Operative Non Opioid Pain Protocol

EXPERIMENTAL

Patients in this group will be administered a novel multimodal pain protocol post-operatively consisting of: Celecoxib, Ketorolac, Gabapentin, Acetaminophen, Diazepam

Drug: Celecoxib; Drug: Ketorolac; Drug: Gabapentin; Drug: Acetaminophen; Drug: Diazepam

Post-Operative Traditional Pain Protocol

ACTIVE COMPARATOR

Patients will be administered a traditional post-operative pain protocol consisting of: Hydrocodone-Acetaminophen Cap 5-500

Drug: Hydrocodone-Acetaminophen

Interventions

Celecoxib DRUG

Post-Operative Non Opioid Pain Protocol

Also known as: Celebrex

Post-Operative Non Opioid Pain Protocol

Ketorolac DRUG

Post-Operative Non Opioid Pain Protocol

Also known as: Tylenol

Post-Operative Non Opioid Pain Protocol

Gabapentin DRUG

Post-Operative Non Opioid Pain Protocol

Also known as: Neurontin

Post-Operative Non Opioid Pain Protocol

Acetaminophen DRUG

Post-Operative Non Opioid Pain Protocol

Also known as: Tylenol

Post-Operative Non Opioid Pain Protocol

Diazepam DRUG

Post-Operative Non Opioid Pain Protocol

Also known as: Valium

Post-Operative Non Opioid Pain Protocol

Hydrocodone-Acetaminophen DRUG

Traditionally used narcotic pain protocol

Also known as: Norco

Post-Operative Traditional Pain Protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All adult patients over age 18 and scheduled for a primary or revision rotator cuff repair

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Health Ford Health System

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Celecoxib; Ketorolac; Acetaminophen; Gabapentin; Diazepam; oxycodone-acetaminophen

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Acetanilides; Anilides; Aniline Compounds; Amines; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Benzodiazepinones; Benzodiazepines; Benzazepines

Results Point of Contact

• Title: Dr. Toufic Jildeh
• Organization: Henry Ford Health System

touficjildeh@gmail.com

(517)2308511

Study Officials

• Toufic R Jildeh, MD

  Resident

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Staff

Study Record Dates

• First Submitted: January 22, 2019
• First Posted: January 28, 2019
• Study Start: January 22, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: April 2, 2024
• Results First Posted: April 2, 2024

Record last verified: 2024-03

Locations

US (1)