Comparison of Bupivacaine Versus Bupivacaine-dexamethasone Infiltration for Postoperative Analgesia in Skin Graft Donor Sites

Comparison of Bupivacaine Versus Bupivacaine-dexamethasone Infiltration for Postoperative Analgesia in Skin Graft Donor Sites, a Randomized Trial

Background: Skin grafting; both partial and complete thickness is frequently used in reconstruction of traumatic soft tissue defects. It is of great value not only for functional and aesthetic purposes in the field of plastic surgery, but also for other surgical specialties.

Of all the problems in the early postoperative period, pain is considered the most important, ameliorating it can lead to significant reduction in postoperative morbidity and faster recovery of the skin donor site.

Objective: To evaluate use of dexamethasone as adjuvant for bupivacaine in subcutaneous local anesthesia infiltration for skin graft donor sites, on quality of pain relief and total dose of analgesic requirements in the early hours postoperatively.

Methods: 97 patients were randomly allocated to receive local bupivacaine infiltration (group LB), or dexamethasone plus bupivacaine (group LB + D) in skin donor site after skin harvesting. In addition to basic demographic data; patients were compared for Numerical Rating Scale (NRS), total dose of morphine or morphine equivalents, time to 1st breakthrough pain, and duration of surgery.

Keywords: Donor site. skin graft. Breakthrough pain. Rescue analgesia. Bupivacaine

Study Overview

• Status: Completed
• Conditions: Postoperative Pain Atskin Graft Site
• Intervention / Treatment: Drug: Xylocaine

Detailed Description

The patients included in the study were randomly allocated to 1 of 2 parallel groups: 1) bupivacaine plus dexamethasone (LB+D) group (n = 50): received 20 ml bupivacaine 0.5% + 18 ml normal saline + 8 mg dexamethasone 2 ml, 2) bupivacaine only (LB) group (n = 50): received 20 ml bupivacaine 0.5% + 20 ml normal saline. A random allocation sequence was generated electronically using online randomization service from https://www.random.org. The project medicine was prepared by 2 independent assistants not involved in other parts of the study. All persons involved were blinded to the randomized allocation.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 02
    • Ramymahrose

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Anesthesiologists Physical Status classification I-II and scheduled for split thickness skin grafting to cover full thickness skin burn or degloving injury after trauma.

Exclusion Criteria:

• were inability to cooperate.
• immunosuppressive therapy.
• Body Mass Index > 35.
• diabetes.
• lower-limb neuropathy.
• daily intake of glucocorticoids or opioids.
• patients who need area of coverage more than 10 cm2.
• allergy to any drug used in the study.
• alcohol or drug abuse.
• American Society of Anesthesiologists Physical Status classification III or more.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: GROUP X(xylocaine); 20 ml bupivacaine 0.5% + 20 ml normal saline.	Drug: Xylocaine; TREATMENT
Active Comparator: GROUPX(Dxylocaine and dexamethasone); 20 ml bupivacaine 0.5% + 18 ml normal saline + 8 mg dexamethasone 2 ml	Drug: Xylocaine; TREATMENT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric Rating scale for pain assesment during the first postoperative 12 hours	TREATMENT	4 MONTHS

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2018
• Primary Completion (Actual): February 10, 2019
• Study Completion (Actual): February 10, 2019

Study Registration Dates

• First Submitted: May 22, 2019
• First Submitted That Met QC Criteria: May 26, 2019
• First Posted (Actual): May 30, 2019

Study Record Updates

• Last Update Posted (Actual): May 30, 2019
• Last Update Submitted That Met QC Criteria: May 26, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Bupivacaine,dexamethasone,Analgesia,Skin Graft ,Donor
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: Ain Shams UNIVER

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No