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The Rule of Bupivacaine Hydrochloride in Skin Graft Donor Site

Bupivacaine Hydrochloride-Soaked Dressing Versus Subcutaneous Infiltration for Postoperative Analgesia in Skin Graft Donor Site: a Randomized Controlled Clinical Trial

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06766474
Enrollment
90
Registered
2025-01-09
Start date
2023-03-01
Completion date
2024-10-30
Last updated
2025-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain Management, Skin Graft Complications

Keywords

bupivacaine, skin graft, pain, donor site, local anesthesia

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 .

Interventions

DRUGBupivacain

to our knowledge, this study is the 1st to compare the efficacy of bupivacaine hydrochloride-soaked dressing versus subcutaneous infiltration for postoperative donor site pain control for patients undergoing STSG procedures.

Sponsors

Minia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
screening pain24 hoursNumerical 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 requirement24 hours1g 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

MeasureTime frameDescription
side effects24 hoursrecording any side effects such as convulsions and myocardial depression.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026