Comparison of Bupivacaine Versus Bupivacaine-dexamethasone Infiltration for Postoperative Analgesia in Skin Graft Donor Sites
Primary Purpose
Postoperative Pain Atskin Graft Site
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Xylocaine
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain Atskin Graft Site focused on measuring Bupivacaine,dexamethasone,Analgesia,Skin Graft ,Donor
Eligibility 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.
Sites / Locations
- Ramymahrose
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
GROUP X(xylocaine)
GROUPX(Dxylocaine and dexamethasone)
Arm Description
20 ml bupivacaine 0.5% + 20 ml normal saline.
20 ml bupivacaine 0.5% + 18 ml normal saline + 8 mg dexamethasone 2 ml
Outcomes
Primary Outcome Measures
Numeric Rating scale for pain assesment during the first postoperative 12 hours
TREATMENT
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03967392
Brief Title
Comparison of Bupivacaine Versus Bupivacaine-dexamethasone Infiltration for Postoperative Analgesia in Skin Graft Donor Sites
Official Title
Comparison of Bupivacaine Versus Bupivacaine-dexamethasone Infiltration for Postoperative Analgesia in Skin Graft Donor Sites, a Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
October 10, 2018 (Actual)
Primary Completion Date
February 10, 2019 (Actual)
Study Completion Date
February 10, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain Atskin Graft Site
Keywords
Bupivacaine,dexamethasone,Analgesia,Skin Graft ,Donor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
DOUBLE BLINDED RANDOMELY CONTROLLED
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GROUP X(xylocaine)
Arm Type
Active Comparator
Arm Description
20 ml bupivacaine 0.5% + 20 ml normal saline.
Arm Title
GROUPX(Dxylocaine and dexamethasone)
Arm Type
Active Comparator
Arm Description
20 ml bupivacaine 0.5% + 18 ml normal saline + 8 mg dexamethasone 2 ml
Intervention Type
Drug
Intervention Name(s)
Xylocaine
Intervention Description
TREATMENT
Primary Outcome Measure Information:
Title
Numeric Rating scale for pain assesment during the first postoperative 12 hours
Description
TREATMENT
Time Frame
4 MONTHS
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
18-75 YEARS
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Ramymahrose
City
Cairo
ZIP/Postal Code
02
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of Bupivacaine Versus Bupivacaine-dexamethasone Infiltration for Postoperative Analgesia in Skin Graft Donor Sites
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