Ketorolac as an Adjuvant Agent for Postoperative Pain Control Following Arthroscopic ACL Surgery

Phase 3

Completed

• Conditions: ACL Injury; Postoperative Pain
• Interventions: Drug: Oxycodone-Acetaminophen; Drug: Ketorolac

• Registration Number: NCT04246554
• Lead Sponsor: University Hospitals Cleveland Medical Center

Brief Summary

1. The investigators aim to examine the use of IV and oral ketorolac as an adjunctive agent to the standard of care pain protocol for postoperative pain control following ACL reconstruction surgery.

2. The investigators hypothesize that the use of IV and oral ketorolac in addition to the standard of care pain protocol will reduce postoperative opioid consumption following ACL reconstruction surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-21
• Study First Submitted: 2020-01-24
• Study First Submitted QC: 2020-01-28
• Study First Posted: 2020-01-29
• Primary Completion: 2020-10-09
• Study Completion: 2021-01-01
• Results First Submitted: 2021-10-18
• Status Verified: 2021-11
• Results First Submitted QC: 2021-11-24
• Last Update Submitted: 2021-11-24
• Results First Posted: 2021-12-21
• Last Update Posted: 2021-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

• Patients between 18 and 89 years old
• Patients undergoing primary anterior cruciate ligament (ACL) reconstruction surgery

Exclusion Criteria

• Patients below age 18 or above age 89
• Illiterate or non-English speaking individuals
• Patients with contraindications to Ketorolac
• History of chronic alcohol or drug abuse
• Chronic use of psychotropic or analgesic drugs
• Known peptic ulcer disease or bleeding diasthesis
• Renal dysfunction (estimated glomerular filtration rate < 50 mL/min/1.73m2)
• Breastfeeding women
• Pregnant women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Oxycodone-Acetaminophen	Patients receive oxycodone- acetaminophen (5mg-325mg) 28 tablets PRN for pain following ACL reconstruction surgery
Ketorolac	Ketorolac	Patients receive IV ketorolac followed by ketorolac 10 mg every 6 hours for 3 days following ACL reconstruction surgery. Patients are additionally discharged with oxycodone- acetaminophen (5mg-325mg) 28 tablets PRN for additional pain control

Primary Outcome Measures

Name	Time	Method
Postoperative Visual Analogue Scale Scores	Up to 8 weeks postoperative	Patients will record their pain on a visual analogue scale with a minimum score of 0 and a maximum score of 100 where lower values indicate a lower pain level, and higher values indicate a higher pain level.

Secondary Outcome Measures

Name	Time	Method
Narcotic Medication	5 days	Number of oxycodone-acetaminophen tablets

Trial Locations

Locations (1)

UH Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States