Clinical Trials Logo

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06465992
Other study ID # DPED20242471
Secondary ID
Status Enrolling by invitation
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


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
See also
  Status Clinical Trial Phase
Completed NCT05619796 - Assessment of Clinical & Radiographic Efficiency of Manual & Pediatric Rotary Systems in Primary Root Canal Preparation N/A
Recruiting NCT05338671 - Effect of Post-Operative Anesthetics on Post-Operative Pain in Patients Receiving Endodontic Treatment Phase 4
Completed NCT05593341 - Opioid Education in Total Knee Arthroplasty N/A
Completed NCT05584696 - Effectiveness of Green Color Exposure on Dental Anxiety N/A
Not yet recruiting NCT05255146 - Cryoanalgesia and Post-thoracotomy Pain in Minimally Invasive Cardiothoracic Surgery N/A
Not yet recruiting NCT06020196 - The Safety and Efficacy of Surgical Rectus Sheath Block for Postoperative Analgesia After Elective Cesarean Delivery N/A
Completed NCT01697748 - Prospective Study on Cesarean Wound Outcomes N/A
Completed NCT01681966 - A Single-dose Open-Label Study to Assess the Safety and Preliminary Efficacy of PRF 110 in Open Herniorrhaphy Surgery Phase 2
Completed NCT01442818 - Patient Satisfaction and Pain Control Following Reconstructive Vaginal Surgery N/A
Completed NCT00625911 - Ketamine Improves Post-Thoracotomy Analgesia N/A
Terminated NCT05494125 - Effects of Continuous ESP Catheters on Recovery, Pain and Opioid Consumption After Multilevel Spine Surgery N/A
Recruiting NCT04767399 - Comparison of Postoperative Pain After Instrumentation in Different Visits With Different Single File Systems. N/A
Not yet recruiting NCT05863624 - Open and Endoscopic Technique in Female Inguinal Hernia Repair. FemaleHernia N/A
Completed NCT06048744 - Ultrasound Guided Erector Spinae Plane Block vs External Oblique Intercostal Plane Block for Nephrectomy N/A
Active, not recruiting NCT05374499 - Double-Blinded Randomized Controlled Study Investigating the Efficacy of Exparel (Liposomal Bupivacaine) for Postoperative Pain Relief in Mandibular Third Molar Extractions Phase 4
Completed NCT06082479 - The Effect of Intra Oral Cryotherapy in Patients With Symptomatic Apical Periodontitis N/A
Completed NCT06065683 - Acute Postoperative Pain Prevalence and Intensity in the First 72 Hours
Completed NCT05552391 - Dexametomedine Versus Ketamine as an Adjuvant in Erector Spinae Block for Perioperative Thoracotomy Pain Control Phase 4
Completed NCT05510947 - Acute Postoperative Pain and Catastrophizing in Patients Undergoing Unicompartmental Knee Arthroplasty
Recruiting NCT04909060 - Does the Newborn Infant Parasympathetic Evaluation (NIPE) Index Predict Postsurgical Pain in Children