Post Operative Pain Management for ACL Reconstruction

Rothman Institute Orthopaedics

Status and phase: Invitation-only; Phase 3

Conditions: Pain, Postoperative

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05316168

ftjo21D.1099

Details and patient eligibility

About

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.

Enrollment: 154 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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154 participants in 2 patient groups

isolated adductor canal block (ACB)

Active Comparator group

Description:

Adductor Canal Block with 20cc 0.5% bupivacaine HCl + 2mg dexamethasone.

Treatment:

Drug: Dexamethasone

Drug: Bupivacaine HCl 0.5% Injectable Solution

Drug: Percocet 5Mg-325Mg Tablet

isolated adductor canal block (ACB) + IPACK

Active Comparator group

Description:

ACB with 20cc 0.5% bupivacaine HCl + 2mg dexamethasone, and iPACK with 20cc 0.5% bupivacaine + 2mg dexamethasone.

Treatment:

Drug: Dexamethasone

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

Drug: Bupivacaine HCl 0.5% Injectable Solution

Drug: Percocet 5Mg-325Mg Tablet