Comparing pain control methods after hernia repair surgery
The Evaluation of Post-operative Pain Control With a TAP Block Using Exparel vs. Marcaine for Hernia Repairs
EARLY_PHASE1 · Our Lady of the Lake Hospital · NCT05177991
This study is testing whether a new pain control method using Liposomal bupivacaine can help people feel better after minimally invasive hernia repair surgery compared to the traditional bupivacaine.
Quick facts
| Phase | EARLY_PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Our Lady of the Lake Hospital (other) |
| Locations | 1 site (Baton Rouge, Louisiana) |
| Trial ID | NCT05177991 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of two different anesthetic techniques for postoperative pain control in patients undergoing minimally invasive hernia repairs. Approximately 200 participants will be randomly assigned to receive either a TAP block using Liposomal bupivacaine (Exparel) or traditional bupivacaine (Marcaine). The study will utilize a permuted block randomization algorithm, ensuring that participants remain blinded to their assigned treatment while surgeons and anesthesiologists will know the anesthetic used. The trial will standardize surgical techniques and anesthesia administration to ensure consistency across all procedures.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a ventral or inguinal hernia requiring surgical repair.
Not a fit: Patients with chronic pain, significant hernia defects, or certain medical histories may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for patients undergoing hernia repair surgeries.
How similar studies have performed: Previous studies have shown promising results with TAP blocks for pain control, but direct comparisons between Exparel and bupivacaine are limited, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years of age or older * Have a ventral or inguinal hernia requiring surgical repair Exclusion Criteria: * Less than 18 years of age * Chronic pain patients * Having a defect \>10 cm in transverse dimension * Having a defect \<4 cm * Has an allergy to bupivacaine * Has recurrent hernias as per medical history * A TAP block performed at any time aside from just prior to the start of the procedure * If bupivacaine is mixed with other anesthetics * Under the instance of an emergency surgery (trauma) * Concomitant surgery * History of EtOH abuse * History of liver/kidney dysfunction * If the procedure must be converted to open * Inidividual's weight \< 50kg * Individual's BMI \> 45
Where this trial is running
Baton Rouge, Louisiana
- Karl LeBlanc — Baton Rouge, Louisiana, United States (RECRUITING)
Study contacts
- Study coordinator: Christine LeBoeuf, DNP
- Email: Christine.LeBoeuf@fmolhs.org
- Phone: 225-765-5956
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Inguinal Hernia, Ventral Hernia