Phase 3 N=90 Randomized Single-blind Treatment

Nonopioid Analgesia After Anterior Cruciate Ligament Reconstruction

Anterior Cruciate Ligament Injury

Bottom Line

View on ClinicalTrials.gov: NCT03818932 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2026

Primary outcome: Primary: Pain Levels Using the Visual Analog Scale — 2.5; 4.06 score on a scale (0-10 on VAS pain scale — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Celecoxib (Drug); Hydrocodone-Acetaminophen (Drug); Ketorolac (Drug); Gabapentin (Drug); Acetaminophen (Drug); Diazepam (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Henry Ford Health System
Primary completion: Jan 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Pain Levels Using the Visual Analog Scale	2.5; 4.06	<0.001 sig
PRIMARY Patient-Reported Outcomes Measurement Information System	61.4; 66.3	<0.001 sig

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

Eligibility Criteria

Eligibility Criteria:

Inclusion Criteria

All adult patients over age 18 and scheduled for a primary or revision anterior cruciate ligament reconstruction

Exclusion Criteria

Exclusion criteria will include patients with a medical history of known allergies or intolerance to allergies or intolerance to Celebrex, Tylenol, Neurontin, dexamethasone, tramadol, substantial alcohol or drug abuse, and pregnancy, history of narcotics within 6 months of surgery, renal impairment, peptic ulcer disease, GI bleeding. Secondary exclusion criterion is an intact anterior cruciate ligament reconstruction

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03818932). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.