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Post Operative Pain Management for ACL Reconstruction

Rothman Institute Orthopaedics logo

Rothman Institute Orthopaedics

Status and phase

Invitation-only
Phase 3

Conditions

Pain, Postoperative

Treatments

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

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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