Clinical trial NCT06766474: The Rule of Bupivacaine Hydrochloride in Skin Graft Donor Site
Official title: Bupivacaine Hydrochloride-Soaked Dressing Versus Subcutaneous Infiltration for Postoperative Analgesia in Skin Graft Donor Site: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Skin Graft Complications
Pain Management
Keywords: bupivacaine
skin graft
pain
donor site
local anesthesia
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2025-01-09
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Split Thickness Skin Graft is frequently utilized for reconstructing skin loss of various causes. Unfortunately, the donor site of the STSG has an unavoidable, annoying post-operative pain

Detailed description: The primary objective of this study was to compare the efficacy of bupivacaine hydrochloride-soaked dressing versus bupivacaine HCL subcutaneous infiltration for postoperative donor site pain control for patients undergoing STSG procedures. The patients were divided in 3 equal groups, investigated soaked dressing vs subcutaneous infiltration vs conventional dressing .

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists Physical Status classification I-II
* scheduled for STSG harvested from a single thigh donor site to reconstruct skin loss post burn or trauma

Exclusion Criteria:

* uncooperative
* refusing patient,
* under immunosuppressive treatment
* diabetics
* lower-limb neuropathy
* under corticosteroids treatment
* allergy to the study drug,
* STSG procedures performed under spinal anesthesia
* pregnancy
* had a history of opioid abuse

Primary outcomes:
measure: screening pain
timeFrame: 24 hours
measure: frequency of analgesia and the fentanyl requirement
timeFrame: 24 hours
Secondary outcomes:
measure: side effects
timeFrame: 24 hours
Other outcomes:
Locations:
city: Minia
country: Egypt
facility: Minia University Hospital
Study officials:
affiliation: Lecturer of plastic and reconstructive surgery
name: MOHAMED SABRY, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistant professor of anesthesia and Intensive Care
name: Shadwa Rabea, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistant lecturer of plastic and reconstructive surgery
name: Mohab Elsayed, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shahzad F. Management of skin graft donor site in pediatric patients with tumescent technique and AQUACEL(R) Ag foam dressing. J Plast Surg Hand Surg. 2021 Oct;55(5):309-314. doi: 10.1080/2000656X.2021.1883632. Epub 2021 Feb 16.
citation: Liu SS, Richman JM, Thirlby RC, Wu CL. Efficacy of continuous wound catheters delivering local anesthetic for postoperative analgesia: a quantitative and qualitative systematic review of randomized controlled trials. J Am Coll Surg. 2006 Dec;203(6):914-32. doi: 10.1016/j.jamcollsurg.2006.08.007. Epub 2006 Oct 25. No abstract available.
citation: Sinha S, Schreiner AJ, Biernaskie J, Nickerson D, Gabriel VA. Treating pain on skin graft donor sites: Review and clinical recommendations. J Trauma Acute Care Surg. 2017 Nov;83(5):954-964. doi: 10.1097/TA.0000000000001615.
citation: Bittner EA, Shank E, Woodson L, Martyn JA. Acute and perioperative care of the burn-injured patient. Anesthesiology. 2015 Feb;122(2):448-64. doi: 10.1097/ALN.0000000000000559.
citation: Akan M, Yildirim S, Misirlioglu A, Ulusoy G, Akoz T, Avci G. An alternative method to minimize pain in the split-thickness skin graft donor site. Plast Reconstr Surg. 2003 Jun;111(7):2243-9. doi: 10.1097/01.PRS.0000060087.93322.2F.