The Rule of Bupivacaine Hydrochloride in Skin Graft Donor Site

NCT06766474 | Completed Phase 2 FDA Drug

• 1 other identifier: bupivacaine analgesia
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

Skin Graft Complications; Pain Management

Keywords

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

Outcome Measures

Primary Outcomes (2)

• screening pain

  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

  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 Outcomes (1)

• side effects

  24 hours

Study Arms (3)

Group I (soaked dressing group)

EXPERIMENTAL

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

Drug: Bupivacain

Group II (subcutaneous infiltration group)

EXPERIMENTAL

Subcutaneous infiltration of the study medication.

Drug: Bupivacain

Group III (control group)

NO INTERVENTION

the conventional dressing was applied without any adjectives

Interventions

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.

Group I (soaked dressing group); Group II (subcutaneous infiltration group)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Minia University Hospital

Minya, Minya Governorate, 61519, Egypt

Location

Related Publications (5)

• Shahzad F. Management of skin graft donor site in pediatric patients with tumescent technique and AQUACEL(R) Ag foam dressing. J Plast Surg Hand Surg. 2021 Oct;55(5):309-314. doi: 10.1080/2000656X.2021.1883632. Epub 2021 Feb 16.

  PMID: 33591240 BACKGROUND

• Liu SS, Richman JM, Thirlby RC, Wu CL. Efficacy of continuous wound catheters delivering local anesthetic for postoperative analgesia: a quantitative and qualitative systematic review of randomized controlled trials. J Am Coll Surg. 2006 Dec;203(6):914-32. doi: 10.1016/j.jamcollsurg.2006.08.007. Epub 2006 Oct 25. No abstract available.

  PMID: 17116561 BACKGROUND

• Sinha S, Schreiner AJ, Biernaskie J, Nickerson D, Gabriel VA. Treating pain on skin graft donor sites: Review and clinical recommendations. J Trauma Acute Care Surg. 2017 Nov;83(5):954-964. doi: 10.1097/TA.0000000000001615.

  PMID: 28598907 BACKGROUND

• Bittner EA, Shank E, Woodson L, Martyn JA. Acute and perioperative care of the burn-injured patient. Anesthesiology. 2015 Feb;122(2):448-64. doi: 10.1097/ALN.0000000000000559.

  PMID: 25485468 BACKGROUND

• Akan M, Yildirim S, Misirlioglu A, Ulusoy G, Akoz T, Avci G. An alternative method to minimize pain in the split-thickness skin graft donor site. Plast Reconstr Surg. 2003 Jun;111(7):2243-9. doi: 10.1097/01.PRS.0000060087.93322.2F.

  PMID: 12794466 BACKGROUND

MeSH Terms

Conditions

Agnosia; Pain

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of plastic and reconstructive surgery, Minia University

Study Record Dates

• First Submitted: January 4, 2025
• First Posted: January 9, 2025
• Study Start: March 1, 2023
• Primary Completion: October 15, 2024
• Study Completion: October 30, 2024
• Last Updated: January 13, 2025

Record last verified: 2025-01

Locations

EG (1)