Liposomal Bupivacaine With Dexamethasone for Foot Surgery

Post Operative Pain Clinical Trial

Official title:

Single-Shot Liposomal Bupivacaine vs. Liposomal Bupivacaine Combined With Dexamethasone Prior to Foot and Ankle Procedures: A Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06465992
• Other study ID #: DPED20242471
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: June 17, 2024
• Est. completion date: June 30, 2025

Study information

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

Clinical Trial Summary

This study aims to understand the ideal formulation to utilize in saphenous nerve and popliteal nerve blocks for foot and ankle procedures. It will examine the use of liposomal bupivacaine alone or liposomal bupivacaine with dexamethasone prior to foot and ankle procedures in peripheral nerve blocks. We will compare liposomal bupivacaine (Exparel) and liposomal bupivacaine (Exparel) combined with dexamethasone to determine if the addition of dexamethasone significantly decreases postoperative narcotic use and prolongs analgesic effects when administered in a popliteal and saphenous block prior to foot and ankle orthopedic procedures.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 126
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participants with foot and ankle procedures at Jefferson Surgery Center, Navy Yard

• Participants with foot and ankle orthopedic procedures requiring a preoperative nerve block

• Age 18 and older

• English speaking

• Ability to complete surveys by phone or in person

• Ability to provide informed consent

Exclusion Criteria:

• Revision foot and ankle cases

• 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

• Participants who are pregnant, plan to become pregnant, or are breastfeeding.

Related Conditions & MeSH terms

• Ankle Surgery
• Foot Surgery
• Pain, Postoperative
• Popliteal Nerve Block
• Post Operative Pain

Intervention

Drug:
• Exparel 266 MG Per 20 ML Injection
20 mL Liposomal bupivacaine (Exparel, 266 mg) will be administered in the popliteal and saphenous block
• Bupivacaine Hcl 0.75% Inj
10 mL of 0.75% bupivacaine will be administered in popliteal and saphenous block
• Dexamethasone
1 mL of 10 mg Dexamethasone will be administered in the popliteal and saphenous 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	Amount of pain medication used after surgery	Collected as tablets taken since all participants will be prescribed oxycodone	14 days
Primary	Pain level after surgery	Participants will be asked daily what their pain levels are using the Visual Analog (VAS) pain scale	14 days