Post Operative Pain Management for ACL Reconstruction

NCT ID: NCT05316168

Last Updated: 2023-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-30

Study Completion Date

2024-09-30

Brief Summary

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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

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Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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isolated adductor canal block (ACB)

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

Group Type ACTIVE_COMPARATOR

Bupivacaine HCl 0.5% Injectable Solution

Intervention Type DRUG

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

Dexamethasone

Intervention Type DRUG

During adductor canal block participants will receive 2mg Dexamethasone

Percocet 5Mg-325Mg Tablet

Intervention Type DRUG

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

isolated adductor canal block (ACB) + IPACK

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

Group Type ACTIVE_COMPARATOR

Bupivacaine HCl 0.5% Injectable Solution

Intervention Type DRUG

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

Dexamethasone

Intervention Type DRUG

During adductor canal block participants will receive 2mg Dexamethasone

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

Intervention Type PROCEDURE

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

Percocet 5Mg-325Mg Tablet

Intervention Type DRUG

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

Interventions

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Bupivacaine HCl 0.5% Injectable Solution

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

Intervention Type DRUG

Dexamethasone

During adductor canal block participants will receive 2mg Dexamethasone

Intervention Type DRUG

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

Intervention Type PROCEDURE

Percocet 5Mg-325Mg Tablet

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rothman Institute Orthopaedics

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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ftjo21D.1099

Identifier Type: -

Identifier Source: org_study_id

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