Ramymahrose
Cairo, 02, Egypt
Completed
NCT Number: NCT03967392
Comparison of Bupivacaine Versus Bupivacaine-dexamethasone Infiltration for Postoperative Analgesia in Skin Graft Donor Sites
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
Completed
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Conditions
Age range
18 year–75 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Xylocaine
DrugTREATMENT
Primary outcomes
-
Numeric Rating scale for pain assesment during the first postoperative 12 hours
Time frame: 4 MONTHS
TREATMENT
Sponsors and collaborators
Lead sponsor
Ain Shams University
Other
Registry information
Official study title
Comparison of Bupivacaine Versus Bupivacaine-dexamethasone Infiltration for Postoperative Analgesia in Skin Graft Donor Sites, a Randomized Trial
Important dates
- Study start
- 2018
- Primary completion
- 2019
- Study completion
- 2019
- First posted
- May 30, 2019
- Registry last updated
- May 30, 2019
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.