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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03967392
Recruitment Status : Completed
First Posted : May 30, 2019
Last Update Posted : May 30, 2019
Sponsor:
Information provided by (Responsible Party):
RAMY AHMED, Ain Shams University

Brief Summary:

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


Condition or disease Intervention/treatment Phase
Postoperative Pain Atskin Graft Site Drug: Xylocaine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: DOUBLE BLINDED RANDOMELY CONTROLLED
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Bupivacaine Versus Bupivacaine-dexamethasone Infiltration for Postoperative Analgesia in Skin Graft Donor Sites, a Randomized Trial
Actual Study Start Date : October 10, 2018
Actual Primary Completion Date : February 10, 2019
Actual Study Completion Date : February 10, 2019


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




Primary Outcome Measures :
  1. Numeric Rating scale for pain assesment during the first postoperative 12 hours [ Time Frame: 4 MONTHS ]
    TREATMENT



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   18-75 YEARS
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03967392


Locations
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Egypt
Ramymahrose
Cairo, Egypt, 02
Sponsors and Collaborators
Ain Shams University
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Responsible Party: RAMY AHMED, lecturer of anesthesia at faculty of medicine ain shams university, Ain Shams University
ClinicalTrials.gov Identifier: NCT03967392    
Other Study ID Numbers: Ain Shams UNIVER
First Posted: May 30, 2019    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by RAMY AHMED, Ain Shams University:
Bupivacaine,dexamethasone,Analgesia,Skin Graft ,Donor
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action