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NCT Number: NCT06766474

The Rule of Bupivacaine Hydrochloride in Skin Graft Donor Site

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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Key information

Conditions

Skin Graft Complications Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain Management Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Minia University Hospital

Minya, Minya Governorate, 61519, Egypt

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacain

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.

Primary outcomes

  1. 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

  2. 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).

Secondary outcomes

  1. side effects

    Time frame: 24 hours

    recording any side effects such as convulsions and myocardial depression.

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 9, 2025
Registry last updated
Jan 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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