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Post Operative Pain Management Through Adductor Canal Block With Bupivacaine for ACL Reconstruction

NCT05161221 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2021-12-17

No results posted yet for this study

Summary

Liposomal bupivacaine injectable suspension (Exparel), manufactured by Pacira Pharmaceuticals, is an FDA-approved, long-lasting nonopioid analgesic that is indicated for single-dose infiltration in adults to produce postsurgical local analgesia. Exparel's extended bioavailability allows for 48 hours of pain control. Periarticular infiltration of liposomal bupivacaine has been safely and effectively used for total knee arthroplasty as an alternative to FNBs, avoiding transient quadriceps weakness and potential in-hospital falls. Recently Exparel has been FDA approved for interscalene brachial plexus nerve block to produce postsurgical regional analgesia for upper extremity/shoulder procedures. It is not yet approved for peripheral nerve blocks of the lower extremity.

No study to date, to our knowledge, has evaluated the efficacy of single-dose adductor canal blockade with Exparel compared to femoral nerve catheter with bupivacaine. We pose that Exparel used for an adductor canal block can offer the benefit of a single-dose injection with extended pain control without the burden of an indwelling catheter and to avoid adverse events of femoral nerve blockade related to quadriceps weakness and dysesthesias.

The purpose of this study is to determine whether adductor canal blockade with liposomal bupivacaine (Exparel) is a safe and effective alternative to femoral nerve catheters for post-operative pain control for patients undergoing ACL reconstruction.

Conditions

  • Pain, Postoperative
  • ACL

Interventions

DRUG

OxyCODONE 5 mg Oral Tablet

Participants will receive 20 OxyCODONE 5 mg Oral Tablet post surgery for pain control

DRUG

Naproxen 500 Mg

Participant will receive Naproxen 500 Mg post surgery for pain control

DRUG

Tylenol Pill

Participants will be instructed to take up to 1000mg of Tylenol by mouth for pain control

DRUG

Liposomal bupivacaine

Participants will receive pre-operative adductor canal block with liposomal bupivacaine (Exparel)

PROCEDURE

Femoral Nerve Catheter

Participants will receive pre-operative femoral nerve catheter

Sponsors & Collaborators

  • Rothman Institute Orthopaedics

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-06
Primary Completion
2022-12-31
Completion
2022-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05161221 on ClinicalTrials.gov