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
Verified date | June 2024 |
Source | Rothman Institute Orthopaedics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Rothman Orthopaedic Institute | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Rothman Institute Orthopaedics |
United States,
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 |
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