Comparison of Bupivacaine Versus Bupivacaine-dexamethasone Infiltration for Postoperative Analgesia in Skin Graft Donor Sites
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|ClinicalTrials.gov Identifier: NCT03967392|
Recruitment Status : Completed
First Posted : May 30, 2019
Last Update Posted : May 30, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||DOUBLE BLINDED RANDOMELY CONTROLLED|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Active Comparator: GROUP X(xylocaine)
20 ml bupivacaine 0.5% + 20 ml normal saline.
Active Comparator: GROUPX(Dxylocaine and dexamethasone)
20 ml bupivacaine 0.5% + 18 ml normal saline + 8 mg dexamethasone 2 ml
- Numeric Rating scale for pain assesment during the first postoperative 12 hours [ Time Frame: 4 MONTHS ]TREATMENT
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03967392
|Cairo, Egypt, 02|