Post Operative Pain Management for ACL Reconstruction

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05316168
• Other study ID #: ftjo21D.1099
• Status: Enrolling by invitation
• Phase: Phase 3
• Start date: September 30, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: September 2023
• Source: Rothman Institute Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 154
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Bupivacaine HCl 0.5% Injectable Solution
During adductor canal block participants will receive 20cc of Bupivacaine HCl 0.5%
• 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

Locations

Country	Name	City	State
United States	Rothman Orthopaedic Institute	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post operative pain management	This will be measured by the participants completing a pain and medication Use questionnaire	14 days
Primary	Post operative pain management 2	Participants will also complete the International Knee Documentation Committee (IKDC) questionnaires	6 months