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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06006624
Other study ID # SHAM2023-2163
Secondary ID
Status Enrolling by invitation
Phase Phase 4
First received
Last updated
Start date August 21, 2023
Est. completion date October 30, 2024

Study information

Verified date June 2024
Source Rothman Institute Orthopaedics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Liposomal bupivacaine or Exparel (Pacira Biosciences) is a long-lasting nonopioid analgesic that was initially utilized as an infiltrative agent but has more recently become U.S. Food and Drug Administration (FDA) approved for use in interscalene brachial plexus nerve blockade as well as infiltrative blockade. Delivery in this form is reported to provide up to 72 hours of extended-release bupivacaine. Exparel's use as a regional anesthetic has also become increasingly common and has shown promise when utilized in Anterior Cruciate Ligament (ACL) reconstruction.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 154
Est. completion date October 30, 2024
Est. primary completion date October 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Paticipants with ACL rupture amenable to reconstruction with BTB autograft identified in clinic by one of 4 different surgeons - Primary ACL Reconstruction with Autograft +/- Partial meniscectomy +/- Lateral extra-articular tenodesis - Age 18 and older - English speaking - Ability to complete surveys by phone or in person - Ability to provide informed consent Exclusion Criteria: - Revision cases - Multi-ligamentous knee injuries - Cartilage or meniscal procedures that prevent adherence to immediate weight bearing and range of motion rehab protocol - ACL reconstruction utilizing non-bone-patellar tendon-bone autografts - Allergies to study medications - Non-English speakers - Known alcohol or narcotic abuse history - Existing contract with a pain specialist due to underlying preoperative pain syndrome - Preoperative opioid use within the 3 months prior to surgery

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Exparel 30 mL
30 mL Liposomal bupivacaine (Exparel) evenly distributed and administered in adductor canal block
0.5% bupivacaine
5 cc's of 0.5% bupivacaine evenly distributed and administered in adductor canal
Dexamethasone
10 mg preservative free Dexamethasone evenly distributed and administered in adductor canal
iPACK block
iPACK (Infiltration between the Popliteal artery and Capsule of the Knee) block

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 Postoperative Pain Daily postoperative VAS (visual analog scale for pain) scale will be collected from participants to assess pain 14 days
Primary Postoperative opioid use assessed using a participant daily diary of how much medication was taken daily for pain 14 days
Primary Postoperative Pain #2 Daily postoperative NRS (numerical rating scale for pain) scale will be collected from participants to assess pain 14 days
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