Clinical Trials Logo
  1. Home
  2. Post-operative Pain
  3. NCT03304444

A Comparison of Exparel to Bupivacaine in TAP Block for Abdominal Gynecologic Surgery

Post Operative Pain Clinical Trial

Official title:
A Pilot Study: A Comparison of Liposomal Bupivacaine to Bupivacaine HCl in Transversus Abdominis Planus Block for Abdominal Gynecologic Surgery

Clinical Trial Summary

This study evaluates the comparison between liposomal bupivacaine versus bupivacaine HCl in Transversus Abdominis Plane blocks for gynecologic surgery on the length of stay in the hospital, total narcotic use, and overall complications rates.

Clinical Trial Description

The proposed pilot study is evaluating the use of Exparel ™ in an anesthesia protocol for patients undergoing major lower abdominal gynecologic surgery. Exparel ™ is a formulation of liposomal bupivicaine that is reputed to have a much longer duration of action compares to bupivacaine. Exparel™ has been originally demonstrated to be safe and effective in bunionectomy and hemorrhoidectomy. It has recently gained FDA approval for all surgical site infiltration including TAP (Transversus Abdominis Planus block) blocks. Exparel™ has also been studied in other procedures and demonstrated reduction in opioid use and median length of stay (LOS).

Currently, patients on the gynecologic oncology service undergoing major abdominal surgery are receiving a type of regional anesthesia using bupivacaine HCl known as a TAP block as part of an effort to decrease narcotic use post-operatively and decrease hospital length of stay. Bupivacaine has a known eight to twelve hour duration of action, thus addressing immediate post operative pain. As Exparel™ is anticipated to have a longer duration of action, the purpose of this study is to determine if TAP blocks with Exparel™ have an advantage over standard TAP blocks with bupivacaine HCl in reducing length of hospital stay in a randomized controlled trial. Our hypothesis is that TAP blocks with Exparel™ will result in reduced length of stay contributing to significant hospital cost savings. Secondary outcomes include total narcotic use (hypothesized to be reduced) and overall complication rates (hypothesized to remain unchanged). Given there are no published data on the efficacy and safety of using Exparel™ in open gynecologic abdominal surgery, this will be a pilot study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03304444
Study type Interventional
Source Abington Memorial Hospital
Contact Heidi Ching, MD
Phone 215-481-4231
Email heidi.ching@jefferson.edu
Status Recruiting
Phase Phase 3
Start date August 2016
Completion date October 2017
View Details
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 NCT06065683 - Acute Postoperative Pain Prevalence and Intensity in the First 72 Hours
Completed NCT06082479 - The Effect of Intra Oral Cryotherapy in Patients With Symptomatic Apical Periodontitis N/A
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