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Post Operative Pain Management for ACL Reconstruction

NCT05316168 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2023-09-21

No results posted yet for this study

Summary

Health care providers are seeking methods to limit post-operative pain and opioid prescriptions to reduce the burden of the national opioid use epidemic. Adductor canal block (ACB) is a peripheral nerve block that has been shown to reduce pain and opioid usage with minimal effect on quadriceps function in patients undergoing arthroscopic knee surgery. Infiltration between Popliteal Artery and Capsule of the Knee (iPACK) block has also shown promise in reducing pain and opioid usage, specifically reducing posterior knee pain, which ACB is not able to achieve. To our knowledge, there is currently no study in the orthopedic literature comparing post-operative pain and opioid consumption in ACL reconstruction (ACLR) patients who received isolated ACB versus ACB with IPACK.

The primary aim of this study is to investigate the role of IPACK in combination with ACB in reducing peri-operative (14-days) pain levels in ACLR patients. The secondary aim is to determine the effectiveness of IPACK in reducing post-operative opioid use. The tertiary aim is to determine any effect of IPACK on post-operative functional outcomes.

Conditions

  • Pain, Postoperative

Interventions

DRUG

Bupivacaine HCl 0.5% Injectable Solution

During adductor canal block participants will receive 20cc of Bupivacaine HCl 0.5%

DRUG

Dexamethasone

During adductor canal block participants will receive 2mg Dexamethasone

PROCEDURE

Infiltration between Popliteal Artery and Capsule of the knee (iPACK)

Prior to closing the surgical wound participants will receive a local injections of 20cc 0.5% bupivacaine mixed with 2mg dexamethasone

DRUG

Percocet 5Mg-325Mg Tablet

Participant will receive 20 Percocet 5/325mg tablets post surgery for pain control

Sponsors & Collaborators

  • Rothman Institute Orthopaedics

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-30
Primary Completion
2024-09-30
Completion
2024-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05316168 on ClinicalTrials.gov