Post Operative Pain Management for ACL Reconstruction

Phase 3

• Conditions: Pain, Postoperative
• Interventions: Drug: Bupivacaine HCl 0.5% Injectable Solution; Drug: Dexamethasone; Drug: Percocet 5Mg-325Mg Tablet; Procedure: Infiltration between Popliteal Artery and Capsule of the knee (iPACK)

• Registration Number: NCT05316168
• Lead Sponsor: Rothman Institute Orthopaedics

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-02
• Study First Submitted QC: 2022-03-30
• Study First Posted: 2022-04-07
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-18
• Last Update Posted: 2023-09-21
• Study Start: 2023-09-30
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 154

Inclusion Criteria

• All patients undergoing primary ACLR for ACL tear, including patients with concomitant meniscectomy or meniscal repair.

Exclusion Criteria

• Revision ACLR, worker's compensation, pregnancy, age<18 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
isolated adductor canal block (ACB)	Percocet 5Mg-325Mg Tablet	Adductor Canal Block with 20cc 0.5% bupivacaine HCl + 2mg dexamethasone.
isolated adductor canal block (ACB) + IPACK	Dexamethasone	ACB with 20cc 0.5% bupivacaine HCl + 2mg dexamethasone, and iPACK with 20cc 0.5% bupivacaine + 2mg dexamethasone.
isolated adductor canal block (ACB)	Bupivacaine HCl 0.5% Injectable Solution	Adductor Canal Block with 20cc 0.5% bupivacaine HCl + 2mg dexamethasone.
isolated adductor canal block (ACB) + IPACK	Bupivacaine HCl 0.5% Injectable Solution	ACB with 20cc 0.5% bupivacaine HCl + 2mg dexamethasone, and iPACK with 20cc 0.5% bupivacaine + 2mg dexamethasone.
isolated adductor canal block (ACB) + IPACK	Infiltration between Popliteal Artery and Capsule of the knee (iPACK)	ACB with 20cc 0.5% bupivacaine HCl + 2mg dexamethasone, and iPACK with 20cc 0.5% bupivacaine + 2mg dexamethasone.
isolated adductor canal block (ACB) + IPACK	Percocet 5Mg-325Mg Tablet	ACB with 20cc 0.5% bupivacaine HCl + 2mg dexamethasone, and iPACK with 20cc 0.5% bupivacaine + 2mg dexamethasone.
isolated adductor canal block (ACB)	Dexamethasone	Adductor Canal Block with 20cc 0.5% bupivacaine HCl + 2mg dexamethasone.

Primary Outcome Measures

Name	Time	Method
Post operative pain management	14 days	This will be measured by the participants completing a pain and medication Use questionnaire
Post operative pain management 2	6 months	Participants will also complete the International Knee Documentation Committee (IKDC) questionnaires

Trial Locations

Locations (1)

Rothman Orthopaedic Institute; 🇺🇸 Philadelphia, Pennsylvania, United States