The Rule of Bupivacaine Hydrochloride in Skin Graft Donor Site

Phase 2

Completed

• Conditions: Skin Graft Complications; Pain Management
• Interventions: Drug: Bupivacain

• Registration Number: NCT06766474
• Lead Sponsor: Minia University

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 .

Study Timeline

• Study Start: 2023-03-01
• Primary Completion: 2024-10-15
• Study Completion: 2024-10-30
• Status Verified: 2025-01
• Study First Submitted: 2025-01-04
• Study First Submitted QC: 2025-01-04
• Study First Posted: 2025-01-09
• Last Update Submitted: 2025-01-09
• Last Update Posted: 2025-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I (soaked dressing group)	Bupivacain	the donor site dressing was kept soaked in an aqueous solution of bupivacaine HCL in a concentration of 0.25%.
Group II (subcutaneous infiltration group)	Bupivacain	Subcutaneous infiltration of the study medication.

Primary Outcome Measures

Name	Time	Method
screening pain	24 hours	Numerical rating scale (NRS), 0, 1, 2, 4, 8, 12, 18 and 24h, a tool for screening pain, often utilized to evaluate pain intensity on a 0-10 scale, where zero indicates no pain and 10 signifies the worst pain possible, in the 1st 24h postoperatively
frequency of analgesia and the fentanyl requirement	24 hours	1g of paracetamol IV was given to all patients every 8 h and if NRS \>3 in the donor site patient received 30 mg IV of ketorolac (the frequency of analgesia), if the pain still, the patient was given fentanyl 50 mcg per time (fentanyl requirement) in the three studied groups Registration of the frequency of time of 1st analgesia, frequency of analgesia (ketorolac) and the fentanyl requirement over 1st 24 h as (0, 1, 2, 4, 8, 12, 18 and 24h).

Secondary Outcome Measures

Name	Time	Method
side effects	24 hours	recording any side effects such as convulsions and myocardial depression.

Trial Locations

Locations (1)

Minia University Hospital; 🇪🇬 Minia, Egypt