## Protocol Section
### Identification Module
**NCT ID:** NCT06427174

**Brief Title:** Analgesic Efficacy of Us Guided Fascia Iliaca Block Versus Caudal Block in Pediatric Graft Surgeries

**Official Title:** Analgesic Efficacy of Us Guided Fascia Iliaca Block Versus Caudal Block in Pediatric Graft Surgeries

#### Organization Study ID Info
**ID:** FB vs CB
#### Organization
**Class:** OTHER
**Full Name:** Assiut University
### Status Module
#### Completion Date
**Date:** 2026-05

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-18

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-04

**Type:** ESTIMATED

#### Start Date
**Date:** 2025-03

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-18
**Study First Submit QC Date:** 2024-05-18
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Assiut University

#### Responsible Party

**Investigator Affiliation:** Assiut University

**Investigator Full Name:** Ahmed Atef Ahmed

**Investigator Title:** Dr

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** The study is aimed to determine which of the two methods , either the fascia iliaca block or the caudal block is better in managing the post operative pain and by which decreasing the consumption of analgesic drugs post operatively and making the patient more comfortable.

**Detailed Description:** 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.(1) Donor site pain is one of the most distressing symptoms reported by patients in the early postoperative period.4,5 Larger donor sites stimulate a greater number of pain receptors and consequently pain is proportional to the size of the graft harvested.6 Often, the donor site is reported to be more painful than the recipient site,7 affecting early mobilization, sleep, and need for analgesics postoperatively.(1) 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.(2) Regional nerve blockade has been proposed for skin graft harvest and proofed to provide better and longer standing analgesia.(2) Application of fascia iliaca compartment block involves the distribution of anesthesia to the territories of the femoral and lateral cutaneous nerves(3) 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%.(4) Prolongation of analgesia after any surgery is the goal of any phsyician ,and Fascia Iliaca Block (FIB), which is widely used for postoperative analgesia in many surgeries, is a nerve block technique with proven efficacy. but which has the superior effect of numbing the pain ..Is it the fascia iliaca erve block or the caudal block .

The objective of this study is to compare post operative analgesic effect and safety of fascia iliaca nerve block versus caudal block in pediatric patient undergoing a graft surgery .

### Conditions Module

**Conditions:**

- Fascia Iliaca Block, Analgesia, Pediatric Surgeries

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Masking Description:** Patients and anesthesiologist won't know which group is patients will selected

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** For the group who will receive the fascia iliaca block .... After induction of the general anesthesia and before skin incision, fascia iliaca block will be performed in the patient while he is in the supine position after sterilization of skin over the groin area at the side from which split thickness graft will be taken, high frequency ultrasound probe

**Intervention Names:**

- Drug: Fascia iliaca block

**Label:** Fascia iliaca group

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** And the second group will receive the caudal block, we use bupivacaine 0.5 mg / kg.

With the patient in the left lateral decubitus position and the hips and knees flexed, the sacral hiatus can be identified .First of all, the posterior superior iliac spines are palpated via anatomical landmarks, the line between both spines (Tuffier's line) representing the base of an equilateral triangle the tip of which indicates the position of the sacral hiatus. The sacrococcygeal ligament can be palpated between the two sacral cornua, which is where the needle should penetrate the skin at an approximate 45° angle. Once the ligament has been passed, a flatter angle is adjusted by descending the needle before it can be advanced to the correct final position.

**Intervention Names:**

- Drug: Caudal block

**Label:** Caudal block

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Fascia iliaca group

**Description:** For the group who will receive the fascia iliaca block .... After induction of the general anesthesia and before skin incision, fascia iliaca block will be performed in the patient while he is in the supine position

**Name:** Fascia iliaca block

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Caudal block

**Description:** second group will receive the caudal block, we use bupivacaine 0.5 mg / kg.

**Name:** Caudal block

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Postoperative analgesia using FLACC score

**Measure:** Postoperative analgesia using FLACC score

**Time Frame:** 1-24 hour postiperative

### Eligibility Module

**Eligibility Criteria:** 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 gaurdian refusal to participate in the study. Known allergy to local anesthetics Coagulopathy. Patient with motor or sensory deficits in lower extremities. Prior surgery of the inguinal or suprainguinal area . Children who are morbidly obese (BMI≥30) because ultrasound guided regional anesthesia could be too technically difficult.

**Healthy Volunteers:** True

**Maximum Age:** 12 Years

**Minimum Age:** 2 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** Tal3t200985@yahoo.com

**Name:** Ahmed Mohamed Atef

**Phone:** 00201003029794

**Role:** CONTACT

**Contact 2:**

**Email:** M.talaat8888@gmail.com

**Name:** Mohamed Talaat Mohamed

**Phone:** 00201062012031

**Role:** CONTACT

### References Module

#### References

**Citation:** Wiegele M, Marhofer P, Lonnqvist PA. Caudal epidural blocks in paediatric patients: a review and practical considerations. Br J Anaesth. 2019 Apr;122(4):509-517. doi: 10.1016/j.bja.2018.11.030. Epub 2019 Feb 1.

**PMID:** 30857607

**Citation:** Bromage PR. A comparison of the hydrochloride salts of lignocaine and prilocaine for epidural analgesia. Br J Anaesth. 1965 Oct;37(10):753-61. doi: 10.1093/bja/37.10.753. No abstract available.

**PMID:** 5847259

**Citation:** Sessler CN, Gosnell MS, Grap MJ, Brophy GM, O'Neal PV, Keane KA, Tesoro EP, Elswick RK. The Richmond Agitation-Sedation Scale: validity and reliability in adult intensive care unit patients. Am J Respir Crit Care Med. 2002 Nov 15;166(10):1338-44. doi: 10.1164/rccm.2107138.

**PMID:** 12421743

**Citation:** Merkel SI, Voepel-Lewis T, Shayevitz JR, Malviya S. The FLACC: a behavioral scale for scoring postoperative pain in young children. Pediatr Nurs. 1997 May-Jun;23(3):293-7.

**PMID:** 9220806

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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

## Derived Section

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Analg

- Name: Analgesics

### Intervention Browse Module - Browse Leaves

- ID: M5315

- Name: Bupivacaine

- Relevance: LOW

- As Found: Unknown

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M4032

- Name: Analgesics

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
