Fascia Iliaca Block Supplemented With Perineural Vs Intravenous Dexamethasone

NCT04561856 | Unknown Phase 4

• 1 other identifier: FIBS
• Study Type: interventional
• Target: 99
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Time of first postoperative analgesia requirement using FLACC score

  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 Outcomes (2)

• Intraoperative blood pressure

  24 Hours

• Intraoperative heart rate

  24 Hours

Study Arms (3)

Group1

ACTIVE COMPARATOR

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

Group2

ACTIVE COMPARATOR

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

Group3

PLACEBO COMPARATOR

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

Interventions

Dexamethasone DRUG

Intravenous 4mg

Group1

Placebo DRUG

Normal Saline 2ml

Group3

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (6)

• Sinha S, Schreiner AJ, Biernaskie J, Nickerson D, Gabriel VA. Treating pain on skin graft donor sites: Review and clinical recommendations. J Trauma Acute Care Surg. 2017 Nov;83(5):954-964. doi: 10.1097/TA.0000000000001615.

  PMID: 28598907 RESULT

• Shank ES, Martyn JA, Donelan MB, Perrone A, Firth PG, Driscoll DN. Ultrasound-Guided Regional Anesthesia for Pediatric Burn Reconstructive Surgery: A Prospective Study. J Burn Care Res. 2016 May-Jun;37(3):e213-7. doi: 10.1097/BCR.0000000000000174.

  PMID: 25412051 RESULT

• Shteynberg A, Riina LH, Glickman LT, Meringolo JN, Simpson RL. Ultrasound guided lateral femoral cutaneous nerve (LFCN) block: safe and simple anesthesia for harvesting skin grafts. Burns. 2013 Feb;39(1):146-9. doi: 10.1016/j.burns.2012.02.015. Epub 2012 May 30.

  PMID: 22657583 RESULT

• Suresh S, Ecoffey C, Bosenberg A, Lonnqvist PA, de Oliveira GS Jr, de Leon Casasola O, de Andres J, Ivani G. The European Society of Regional Anaesthesia and Pain Therapy/American Society of Regional Anesthesia and Pain Medicine Recommendations on Local Anesthetics and Adjuvants Dosage in Pediatric Regional Anesthesia. Reg Anesth Pain Med. 2018 Feb;43(2):211-216. doi: 10.1097/AAP.0000000000000702.

  PMID: 29319604 RESULT

• Hewson D, Bedforth N, McCartney C, Hardman J. Dexamethasone and peripheral nerve blocks: back to basic (science). Br J Anaesth. 2019 Apr;122(4):411-412. doi: 10.1016/j.bja.2019.02.004. Epub 2019 Feb 25. No abstract available.

  PMID: 30857596 RESULT

• Veneziano G, Martin DP, Beltran R, Barry N, Tumin D, Burrier C, Klingele K, Bhalla T, Tobias JD. Dexamethasone as an Adjuvant to Femoral Nerve Block in Children and Adolescents Undergoing Knee Arthroscopy: A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial. Reg Anesth Pain Med. 2018 May;43(4):438-444. doi: 10.1097/AAP.0000000000000739.

  PMID: 29377866 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

Hany Ahmed Ibrahim El morabaa, Professor

CONTACT

01005203980; hany.ibrahim@med.au.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 20, 2020
• First Posted: September 24, 2020
• Study Start: September 30, 2020
• Primary Completion: September 30, 2021
• Study Completion: April 20, 2022
• Last Updated: September 24, 2020

Record last verified: 2020-09