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Post Operative Pain Management for ACL Reconstruction

Primary Purpose

Pain, Postoperative

Status

Enrolling by invitation

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Bupivacaine HCl 0.5% Injectable Solution

Dexamethasone

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

Percocet 5Mg-325Mg Tablet

About this trial

This is an interventional prevention trial for Pain, Postoperative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Rothman Orthopaedic Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

isolated adductor canal block (ACB)

isolated adductor canal block (ACB) + IPACK

Arm Description

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

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

Outcomes

Primary Outcome Measures

Post operative pain management

This will be measured by the participants completing a pain and medication Use questionnaire

Post operative pain management 2

Participants will also complete the International Knee Documentation Committee (IKDC) questionnaires

Secondary Outcome Measures

Full Information

NCT ID

NCT05316168

First Posted

December 2, 2021

Last Updated

September 18, 2023

Sponsor

Rothman Institute Orthopaedics

1. Study Identification

Unique Protocol Identification Number

NCT05316168

Brief Title

Post Operative Pain Management for ACL Reconstruction

Official Title

Isolated Adductor Canal Block vs Adductor Canal Block With IPACK in ACL Reconstruction: A Randomized, Prospective Trial

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Enrolling by invitation

Study Start Date

September 30, 2023 (Anticipated)

Primary Completion Date

September 30, 2024 (Anticipated)

Study Completion Date

September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rothman Institute Orthopaedics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Postoperative

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

154 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

isolated adductor canal block (ACB)

Arm Type

Active Comparator

Arm Description

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

Arm Title

isolated adductor canal block (ACB) + IPACK

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Bupivacaine HCl 0.5% Injectable Solution

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Intervention Description

During adductor canal block participants will receive 2mg Dexamethasone

Intervention Type

Procedure

Intervention Name(s)

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

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Percocet 5Mg-325Mg Tablet

Intervention Description

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

Primary Outcome Measure Information:

Title

Post operative pain management

Description

This will be measured by the participants completing a pain and medication Use questionnaire

Time Frame

14 days

Title

Post operative pain management 2

Description

Participants will also complete the International Knee Documentation Committee (IKDC) questionnaires

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Rothman Orthopaedic Institute

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

12. IPD Sharing Statement

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Post Operative Pain Management for ACL Reconstruction

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