The Rule of Bupivacaine Hydrochloride in Skin Graft Donor Site

January 9, 2025 updated by: MOHAMED SABRY, Minia University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Minia, Egypt, 61519
        • Minia University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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%.
Drug: 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.
Experimental: Group II (subcutaneous infiltration group)
Subcutaneous infiltration of the study medication.
Drug: 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.
No Intervention: Group III (control group)
the conventional dressing was applied without any adjectives

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
screening pain
Time Frame: 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
24 hours
frequency of analgesia and the fentanyl requirement
Time Frame: 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).
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
side effects
Time Frame: 24 hours
recording any side effects such as convulsions and myocardial depression.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minia University

Investigators

  • Principal Investigator: MOHAMED SABRY, MD, Lecturer of plastic and reconstructive surgery
  • Principal Investigator: Shadwa Rabea, MD, Assistant professor of anesthesia and Intensive Care
  • Principal Investigator: Mohab Elsayed, Phd, Assistant lecturer of plastic and reconstructive surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Actual)

October 15, 2024

Study Completion (Actual)

October 30, 2024

Study Registration Dates

First Submitted

January 4, 2025

First Submitted That Met QC Criteria

January 4, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 9, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • bupivacaine analgesia

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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