Fascia Iliaca Block Supplemented With Perineural Vs Intravenous Dexamethasone

Phase 4

• Conditions: Postoperative Pain
• Interventions: Drug: Dexamethasone; Drug: Placebo

• Registration Number: NCT04561856
• Lead Sponsor: Assiut University

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2020-09
• Study First Submitted: 2020-09-20
• Study First Submitted QC: 2020-09-22
• Last Update Submitted: 2020-09-22
• Study First Posted: 2020-09-24
• Last Update Posted: 2020-09-24
• Study Start: 2020-09-30
• Primary Completion: 2021-09-30
• Study Completion: 2022-04-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 99

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group1	Dexamethasone	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.
Group2	Dexamethasone	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.
Group3	Placebo	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.

Primary Outcome Measures

Name	Time	Method
Time of first postoperative analgesia requirement using FLACC score	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.

Secondary Outcome Measures

Name	Time	Method
Intraoperative blood pressure	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.
Intraoperative heart rate	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.