Fascia Iliaca Block Supplemented With Perineural Vs Intravenous Dexamethasone

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-30

Study Completion Date

2022-04-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Dexamethasone as Adjuvant to Bupivacaine in Suprazygomatic Maxillary Nerve Block

NCT05530811

Nerve Block

UNKNOWN NA

Effect of Intravenous Dexamethasone With Pudendal Nerve Block on Postoperative Pain in Pediatric Hypospadias Repair

NCT03902249

Postoperative Pain Hypospadias

COMPLETED PHASE4

Dexamethasone and Block Duration in Upper Extremity

NCT01756573

Duration of Pain Relief

TERMINATED NA

Dexamethasone vs Dexmedetomidine vs Combination as Adjuvants to Popliteal Sciatic Nerve Block in Children

NCT07289620

Ankle Disease Foot Diseases

RECRUITING NA

Effect of Dexamethasone as an Adjuvant to Bupivacaine in Bilateral Erector Spinae Block on Postoperative Pain and Diaphragmatic Function After Pediatric Cardiac Surgeries : A Randomized Controlled Clinical Trial

NCT05536063

Pediatric Cardiac Surgery

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

Intravenous 4mg

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.

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

Perineural 4mg

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Normal Saline 2ml

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dexamethasone

Intravenous 4mg

Intervention Type DRUG

Dexamethasone

Perineural 4mg

Intervention Type DRUG

Placebo

Normal Saline 2ml

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No