Post Operative Pain Management for ACL Reconstruction

NCT05316168 | Unknown Phase 3 FDA Drug

• 1 other identifier: ftjo21D.1099
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (2)

• Post operative pain management

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

  14 days

• Post operative pain management 2

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

  6 months

Study Arms (2)

isolated adductor canal block (ACB)

ACTIVE COMPARATOR

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

Drug: Bupivacaine HCl 0.5% Injectable Solution; Drug: Dexamethasone; Drug: Percocet 5Mg-325Mg Tablet

isolated adductor canal block (ACB) + IPACK

ACTIVE COMPARATOR

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

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

Interventions

Bupivacaine HCl 0.5% Injectable Solution DRUG

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

isolated adductor canal block (ACB); isolated adductor canal block (ACB) + IPACK

Dexamethasone DRUG

During adductor canal block participants will receive 2mg Dexamethasone

isolated adductor canal block (ACB); isolated adductor canal block (ACB) + IPACK

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

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

isolated adductor canal block (ACB) + IPACK

Percocet 5Mg-325Mg Tablet DRUG

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

isolated adductor canal block (ACB); isolated adductor canal block (ACB) + IPACK

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Rothman Institute Orthopaedics: lead

Study Sites (1)

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine; Dexamethasone; oxycodone-acetaminophen

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: April 7, 2022
• Study Start: September 30, 2023
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

US (1)