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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

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

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

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

NCT ID

NCT03967392

First Posted

May 22, 2019

Last Updated

May 26, 2019

Sponsor

Ain Shams University

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

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

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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