Post Operative Pain Management for ACL Reconstruction

Sponsor

Rothman Institute Orthopaedics (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05316168

Collaborator

(none)

154

Enrollment

Location

Arms

8.1

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative	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	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

154 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Mar 30, 2022

Anticipated Primary Completion Date :

Dec 2, 2022

Anticipated Study Completion Date :

Dec 2, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: isolated adductor canal block (ACB) Adductor Canal Block with 20cc 0.5% bupivacaine HCl + 2mg dexamethasone.	Drug: Bupivacaine HCl 0.5% Injectable Solution During adductor canal block participants will receive 20cc of Bupivacaine HCl 0.5% Drug: Dexamethasone During adductor canal block participants will receive 2mg Dexamethasone Drug: Percocet 5Mg-325Mg Tablet Participant will receive 20 Percocet 5/325mg tablets post surgery for pain control
Active Comparator: isolated adductor canal block (ACB) + IPACK 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 During adductor canal block participants will receive 20cc of Bupivacaine HCl 0.5% Drug: Dexamethasone During adductor canal block participants will receive 2mg Dexamethasone Procedure: 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 Drug: Percocet 5Mg-325Mg Tablet Participant will receive 20 Percocet 5/325mg tablets post surgery for pain control

Arm

Intervention/Treatment

Active Comparator: isolated adductor canal block (ACB)

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

Drug: Bupivacaine HCl 0.5% Injectable Solution

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

Drug: Dexamethasone

During adductor canal block participants will receive 2mg Dexamethasone

Drug: Percocet 5Mg-325Mg Tablet

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

Active Comparator: isolated adductor canal block (ACB) + IPACK

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

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

Drug: Dexamethasone

During adductor canal block participants will receive 2mg Dexamethasone

Procedure: 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

Drug: Percocet 5Mg-325Mg Tablet

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

Outcome Measures

Primary Outcome Measures

Post operative pain management [14 days]
This will be measured by the participants completing a pain and medication Use questionnaire
Post operative pain management 2 [6 months]
Participants will also complete the International Knee Documentation Committee (IKDC) questionnaires

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rothman Orthopaedic Institute	Philadelphia	Pennsylvania	United States	19107

Sponsors and Collaborators

Rothman Institute Orthopaedics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rothman Institute Orthopaedics

ClinicalTrials.gov Identifier:

NCT05316168

Other Study ID Numbers:

ftjo21D.1099

First Posted:

Apr 7, 2022

Last Update Posted:

Apr 7, 2022

Last Verified:

Dec 1, 2021

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

Additional relevant MeSH terms:

Pain, Postoperative

Dexamethasone

Bupivacaine

Study Results

No Results Posted as of Apr 7, 2022