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

NCT ID: NCT03967392

Last Updated: 2019-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-10
• Study Completion Date: 2019-02-10

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.

Conditions

Postoperative Pain Atskin Graft Site

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

GROUP X(xylocaine)

20 ml bupivacaine 0.5% + 20 ml normal saline.

Group Type: ACTIVE_COMPARATOR

Xylocaine

Intervention Type: DRUG

TREATMENT

GROUPX(Dxylocaine and dexamethasone)

20 ml bupivacaine 0.5% + 18 ml normal saline + 8 mg dexamethasone 2 ml

Group Type: ACTIVE_COMPARATOR

Xylocaine

Intervention Type: DRUG

TREATMENT

Interventions

Xylocaine

TREATMENT

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

RAMY AHMED

lecturer of anesthesia at faculty of medicine ain shams university

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ramymahrose

Cairo, , Egypt

Countries

Egypt

Other Identifiers

Ain Shams UNIVER

Identifier Type: -

Identifier Source: org_study_id