Comparing Liposomal Bupivacaine and Lidocaine for Pain Relief at Skin Graft Donor Sites
Prospective Study of Liposomal Bupivacaine for Pain Control of Split Thickness Skin Graft Donor Sites
This study is testing whether a new pain relief option called liposomal bupivacaine works better than the standard lidocaine for managing pain after skin grafts in burn patients.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Kansas Medical Center Academic / other |
| Locations | 1 site (Kansas City, Kansas) |
| Trial ID | NCT03854344 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of liposomal bupivacaine compared to lidocaine for managing postoperative pain at skin graft donor sites in patients with burn injuries. It consists of two phases: the first phase is a randomized controlled trial comparing standard lidocaine injections to liposomal bupivacaine during skin graft harvesting. The second phase involves administering regional nerve blocks preoperatively and comparing outcomes to historical controls from the first phase. Pain levels and opioid consumption will be measured postoperatively using validated assessment scales.
Who should consider this trial
Good fit: Ideal candidates are Spanish or English-speaking patients with less than 20% total body surface area (TBSA) burns and less than 5% deep partial or full thickness burns.
Not a fit: Patients with chronic pain syndromes, greater than 20% TBSA burns, or allergies to local anesthetics 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 skin graft procedures.
How similar studies have performed: Other studies have shown promising results with liposomal bupivacaine in pain management, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Spanish/English speaking * \<20%TBSA; \<5% TBSA deep partial or full thickness burns Exclusion Criteria: * chronic pain syndrome * \> 20% TBSA burn injury; \> 5% TBSA deep partial or full thickness burn * pregnant * allergy to lidocaine or other local anesthetics * burns to anterior thighs
Where this trial is running
Kansas City, Kansas
- The University of Kansas Health System — Kansas City, Kansas, United States (Recruiting)
Study contacts
- Study coordinator: Jessica Reynolds, BSN
- Email: jreynolds11@kumc.edu
- Phone: 913-588-0044
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.