Fascia Iliaca Block Supplemented With Perineural Vs Intravenous Dexamethasone (Interventional)

September 22, 2020 updated by: Aya Mahmoud Abbas, Assiut University

Fascia Iliaca Block Supplemented With Perineural Vs Intravenous Dexamethasone: Effect On Post-Operative Pain In Children Undergoing Split Thickness Skin Grafting.

Split-thickness skin grafting is the current standard of care for the reconstructive procedures in managing burn injuries and traumatic tissue defects. Harvesting split-thickness skin creates a new partial thickness wound that is referred to as the donor site . Donor site pain is one of the most distressing symptoms reported by patients in the early postoperative period. Larger donor sites stimulate a greater number of pain receptors and consequently pain is proportional to the size of the graft harvested.Often, the donor site is reported to be more painful than the recipient site,affecting early mobilization, sleep, and need for analgesics postoperatively.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Most commonly split thickness auto-grafts are harvested from a convenient and minimally aesthetically intrusive site; often the lateral thigh area, which is innervated by lateral femoral cutaneous nerve (LFCN). However if a larger graft area in needed then it will be obtained from the anterior aspect of the thigh, which is innervated by the femoral nerve.

Regional nerve blockade has been proposed for skin graft harvest and proofed to provide better and longer standing analgesia. Application of fascia iliaca compartment block involves the distribution of anesthesia to the territories of the femoral and lateral cutaneous nerves.

American society of regional anesthesia and pain medicine recommendations on local anesthetics in pediatric regional anesthesia in 2018 stated that the ultrasound guided fascial plane blocks as fascia iliaca block can be successfully and safely performed using a recommended dose of 0.25-0.75 mg/kg of bupivacaine 0.25%.

Prolongation of analgesia after surgery under regional anaesthesia is a goal for clinicians. Many investigators have sought that the ideal analgesic adjuvant that would both prolongs pain relief and avoids side effects after a single-shot peripheral nerve block. Although many agents have failed this test (opioids, ketamine, clonidine, etc.), the perineural addition of dexamethasone to local anaesthetic has been shown in several studies to prolong the analgesic effect and its use has become common in clinical practice around the world. Not surprisingly, much research has been performed with the aim of providing Level 1 evidence via randomized controlled trials design and systematic review and meta-analysis. Despite this, there is still no adequate answer as to whether perineural dexamethasone is superior to systemic administration alone.

Study Type

Interventional

Enrollment (Anticipated)

99

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria: • Age 2 -12 years.

  • ASA I - II
  • Scheduled for split thickness grafting.
  • Availability and suitability of lateral and anterior aspects of the thigh as a donor site.

Exclusion Criteria:

  • Patient's guardian refusal to participate in the study.
  • Known allergy to local anesthetics
  • Children known to be diabetic.
  • Coagulopathy.
  • Children with motor or sensory deficits in lower extremities.
  • Children who are morbidly obese (BMI≥35) because ultrasound guided regional anesthesia could be technically difficult.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group1
will include 33 patients: each one will receive US guided fascia-iliaca block with 0.7 ml/kg of bupivacaine 0.25% plus 2 ml of normal saline perinural plus 0.15 mg/kg dexamethasone (maximum of 4 mg) in 2 ml volume intravenously.
Drug: Dexamethasone
Intravenous 4mg
Drug: Dexamethasone
Perineural 4mg
Active Comparator: Group2
will include 33 patients: each one will receive US guided fascia-iliaca block with 0.7 ml/kg of bupivacaine 0.25% plus 0.15 mg/kg dexamethasone (maximum of 4 mg) in 2 ml volume perinural plus 2 ml of normal saline intravenously.
Drug: Dexamethasone
Intravenous 4mg
Drug: Dexamethasone
Perineural 4mg
Placebo Comparator: Group3
will include 33 patients: each one will receive US guided fascia-iliaca block with 0.7 ml/kg of bupivacaine 0.25% plus 2 ml of normal saline perinural plus 2 ml of normal saline intravenously.
Drug: Placebo
Normal Saline 2ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time of first postoperative analgesia requirement using FLACC score
Time Frame: 24 Hours
FLACC Score for the first 24 hours postoperative; 0 = Relaxed and comfortable, 1-3 = Mild discomfort, 4-6 = Moderate pain, 7-10 = Severe discomfort/pain or both.And The total consumption of postoperative rescue analgesics (total of paracetamol doses) will be recorded over 24 hours.
24 Hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative blood pressure
Time Frame: 24 Hours
Intraoperative blood pressure will be recorded every 3 minutes till the end of the procedure then postoperative at 1,2, 4,8,12,16 and 24 hours.
24 Hours
Intraoperative heart rate
Time Frame: 24 Hours
Intraoperative heart rate will be recorded every 3 minutes till the end of the procedure then postoperative at 1,2, 4,8,12,16 and 24 hours.
24 Hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 30, 2020

Primary Completion (Anticipated)

September 30, 2021

Study Completion (Anticipated)

April 20, 2022

Study Registration Dates

First Submitted

September 20, 2020

First Submitted That Met QC Criteria

September 22, 2020

First Posted (Actual)

September 24, 2020

Study Record Updates

Last Update Posted (Actual)

September 24, 2020

Last Update Submitted That Met QC Criteria

September 22, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIBS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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