drugset / Trial / NCT03818932

Nonopioid Analgesia After Anterior Cruciate Ligament Reconstruction

NCT03818932 ↗

Phase 2/3 Completed 90 enrolled Henry Ford Health System
RandomizedParallel-groupSingle-blindTreatment

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

Timeline

Start
2019-01-22
Primary completion
2020-01-20
Completion
2020-05-20

Outcome

Mixed primary results

registry MEAN Post-Operative Non Opioid Pain Protocol: 2.5 (2.29 to 2.71) score on a scale (0-10 on VAS pain scale NCT03818932 ↗

registry analysis (superiority test); Post-Operative Non Opioid Pain Protocol vs Post-Operative Traditional Pain Protocol; p <0.001; t-test, 2 sided NCT03818932 ↗

registry MEAN Post-Operative Non Opioid Pain Protocol: 61.4 (Standard Deviation 8.9) score on a scale NCT03818932 ↗

registry MEAN Post-Operative Traditional Pain Protocol: 66.3 (Standard Deviation 8.2) score on a scale NCT03818932 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Acetaminophen Small molecule — —
Subject Celecoxib Other / unclassified — —
Subject Diazepam Small molecule — —
Subject Gabapentin Unknown — —
Comparator Hydrocodone-Acetaminophen Unknown — —
Subject Ketorolac Other / unclassified — —

Indications

No indication recorded.