Liposomal Bupivacaine With Dexamethasone for Foot Surgery

NCT06465992 | Enrolling By Invitation Phase 4 FDA Drug

• 1 other identifier: DPED20242471
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Foot Surgery; Ankle Surgery; Post Operative Pain; Popliteal Nerve Block

Outcome Measures

Primary Outcomes (2)

• Amount of pain medication used after surgery

  Collected as tablets taken since all participants will be prescribed oxycodone

  14 days

• Pain level after surgery

  Participants will be asked daily what their pain levels are using the Visual Analog (VAS) pain scale

  14 days

Study Arms (2)

Study Group 1: Foot/Ankle Surgery with Exparel Nerve Block

ACTIVE COMPARATOR

Prior to participants surgical procedure, the anesthesiologist will administer a popliteal and saphenous nerve block consisting of 20 mL Liposomal bupivacaine (Exparel) + 10 mL of 0.75% bupivacaine

Drug: Exparel 266 MG Per 20 ML Injection; Drug: Bupivacaine Hcl 0.75% Inj

Study Group 2: Foot/Ankle Surgery with Exparel + Dexamethasone Nerve Block

ACTIVE COMPARATOR

Prior to participants surgical procedure, the anesthesiologist will administer a popliteal and saphenous nerve block consisting of 20 mL Liposomal bupivacaine (Exparel) + 1 mL of 10 mg preservative free Dexamethasone + 10 cc's of 0.75% bupivacaine

Drug: Exparel 266 MG Per 20 ML Injection; Drug: Bupivacaine Hcl 0.75% Inj; Drug: Dexamethasone

Interventions

Exparel 266 MG Per 20 ML Injection DRUG

20 mL Liposomal bupivacaine (Exparel, 266 mg) will be administered in the popliteal and saphenous block

Study Group 1: Foot/Ankle Surgery with Exparel Nerve Block; Study Group 2: Foot/Ankle Surgery with Exparel + Dexamethasone Nerve Block

Bupivacaine Hcl 0.75% Inj DRUG

10 mL of 0.75% bupivacaine will be administered in popliteal and saphenous block

Study Group 1: Foot/Ankle Surgery with Exparel Nerve Block; Study Group 2: Foot/Ankle Surgery with Exparel + Dexamethasone Nerve Block

Dexamethasone DRUG

1 mL of 10 mg Dexamethasone will be administered in the popliteal and saphenous block

Study Group 2: Foot/Ankle Surgery with Exparel + Dexamethasone Nerve Block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rothman Institute Orthopaedics: lead

Study Sites (1)

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Injections; Bupivacaine; Dexamethasone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2024
• First Posted: June 20, 2024
• Study Start: June 17, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: June 20, 2024

Record last verified: 2024-06

Locations

US (1)