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

NCT03967392 | Completed Phase 4

• 1 other identifier: Ain Shams UNIVER
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Postoperative Pain Atskin Graft Site

Keywords

Bupivacaine,dexamethasone,Analgesia,Skin Graft ,Donor

Outcome Measures

Primary Outcomes (1)

• Numeric Rating scale for pain assesment during the first postoperative 12 hours

  TREATMENT

  4 MONTHS

Study Arms (2)

GROUP X(xylocaine)

ACTIVE COMPARATOR

20 ml bupivacaine 0.5% + 20 ml normal saline.

Drug: Xylocaine

GROUPX(Dxylocaine and dexamethasone)

ACTIVE COMPARATOR

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

Drug: Xylocaine

Interventions

Xylocaine DRUG

TREATMENT

GROUP X(xylocaine); GROUPX(Dxylocaine and dexamethasone)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: 18-75 YEARS
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Anesthesiologists Physical Status classification I-II and scheduled for split thickness skin grafting to cover full thickness skin burn or degloving injury after trauma.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ramymahrose

Cairo, 02, Egypt

Location

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia at faculty of medicine ain shams university

Model Details: DOUBLE BLINDED RANDOMELY CONTROLLED

Study Record Dates

• First Submitted: May 22, 2019
• First Posted: May 30, 2019
• Study Start: October 10, 2018
• Primary Completion: February 10, 2019
• Study Completion: February 10, 2019
• Last Updated: May 30, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)