NCT06561035

ACL-R Opioid Sparing Study

Opiate Sparing Pain Management Protocol After Anterior Cruciate Ligament Reconstruction Surgery

• Status: Enrolling By Invitation
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Campbell Clinic · Academic / Other
• Sex: All
• Age: 14 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized control trial to investigate the effectiveness of a multimodal opiate sparing analgesic regimen in controlling post-operative pain and potentially reduce post-operative opioid consumption in patients undergoing Anterior Cruciate Ligament Reconstruction (ACL-R).

Detailed description

There is increased attention on opioid prescription patterns and post-operative narcotic consumption in light of the ongoing opioid crisis in the United States. Patients with opioid use disorders often have their first exposure to opioids following a medical or surgical procedure (Shah et al., 2019). Approximately 6% of patients who were opioid native preoperatively and received opioids postoperatively became long term users. As orthopedic surgeons account for approximately 8% of all dispensed opioid prescriptions (Volkow et al., 2011), surgeons have investigated the effectiveness of multimodal analgesic regimens in controlling post-operative pain and reducing the amount of opioid consumption. Recent studies have shown that an opiate sparing regimen consisted of nonsteroidal anti-inflammatory drugs can control post-operative pain adequately while reducing opioid consumption in patients who underwent arthroscopic knee or shoulder surgeries (Gazendam et al., 2022; Jones et al., 2022). Currently, there is no clear consensus on pain management regimen after anterior cruciate ligament reconstruction. The purpose of this study is to 1) investigate the difference in pain score and opioid consumption among patients who receive the opioid-based protocol and those who receive opioid-sparing protocol; 2) minimize and potentially eliminate the utilization of narcotics following anterior cruciate ligament reconstruction (ACL-R) surgery.

Conditions

• Anterior Cruciate Ligament Injuries

Interventions

Type	Name	Description
DRUG	Opiate Sparing	Subjects will receive medications in the Opiate Sparing arm for pain control.
DRUG	Opiate Based	Subjects will receive medications in the Opiate Based arm for pain control.

Timeline

• Start date: 2024-09-01
• Primary completion: 2025-08-01
• Completion: 2026-06-01
• First posted: 2024-08-19
• Last updated: 2024-08-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study