Nonopioid Analgesia After Anterior Cruciate Ligament Reconstruction

NCT03818932 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 123192
• Study Type: interventional
• Target: 90
• 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 anterior cruciate ligament reconstruction: a treatment group given a nonopioid pain control regimen, and a standard of care control group given standard opioid pain control regimen

Conditions

Anterior Cruciate Ligament Injury

Outcome Measures

Primary Outcomes (2)

• Pain Levels Using the Visual Analog Scale

  Patients record pain levels using Visual analog scales for 10 days post-operatively. The visual analog scale is a validated measure for pain where 0 is no pain and 10 is the worst pain. Average daily pain was calculated for each patient. Higher values portend worse control.

  10 days post-operatively

• Patient-Reported Outcomes Measurement Information System

  Patient-Reported Outcomes Measurement Information System Physical Function (PROMIS PF) scores will be collected once preoperatively and at 10 days postoperatively. The PROMIS PF is scored on a 0-point to 100-point scale, with a population mean of 50 and SD of 10. 0 is equivalent to no physical function and 100 is equivalent to total physical function.

  From preoperative visit to 10 days post-operatively

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

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: Toradol

Post-Operative Non Opioid Pain Protocol

Hydrocodone-Acetaminophen DRUG

Traditionally used narcotic pain protocol

Also known as: Norco

Post-Operative Traditional Pain Protocol

Gabapentin DRUG

Post-Operative Non Opioid Pain Protocol

Also known as: Neurotin

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

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 anterior cruciate ligament reconstruction

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

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

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and 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; 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; Acetanilides; Anilides; Aniline Compounds; Benzodiazepinones; Benzodiazepines; Benzazepines

Limitations and Caveats

Patients were aware of the medicines they were taking, and knowledge of the treatment may have led to cognitive bias; however, data were recorded by a blinded observer with no knowledge of patient randomization in order to eliminate associated statistical bias.

Results Point of Contact

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

touficjildeh@gmail.com

15172308511

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: SPONSOR

Study Record Dates

• First Submitted: January 23, 2019
• First Posted: January 28, 2019
• Study Start: January 22, 2019
• Primary Completion: January 20, 2020
• Study Completion: May 20, 2020
• Last Updated: March 19, 2026
• Results First Posted: March 19, 2026

Record last verified: 2024-03

Locations

US (1)