The Rule of Bupivacaine Hydrochloride in Skin Graft Donor Site

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2024-10-30

Brief Summary

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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

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Detailed Description

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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 .

Conditions

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Skin Graft Complications Pain Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Group I (soaked dressing group)

the donor site dressing was kept soaked in an aqueous solution of bupivacaine HCL in a concentration of 0.25%.

Group Type EXPERIMENTAL

Bupivacain

Intervention Type DRUG

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.

Group II (subcutaneous infiltration group)

Subcutaneous infiltration of the study medication.

Group Type EXPERIMENTAL

Bupivacain

Intervention Type DRUG

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.

Group III (control group)

the conventional dressing was applied without any adjectives

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Bupivacain

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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No