Ultrasound Guided Subgluteal Sciatic Nerve Block Versus Caudal Analgesia for Cerebral Palsy Patients Undergoing Lower Limb Corrective Surgeries

NCT05774132 | Completed

• 1 other identifier: FMASU R24/ 2023
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Both caudal and peripheral nerve blocks are widely used for postoperative analgesia in pediatric population .The safety of both techniques has been documented especially after the application of ultrasound guidance for their performance. Patients with cerebral palsy usually require lower limb orthopedic surgeries,that extend from minor soft tissue releases, like tenotomies, tendon lengthening or transfer, to major osteotomies for correction of their limb deformities. Study objective: to compare the efficacy of ultrasound guided caudal block with subgluteal sciatic nerve block for postoperative pain control in pediatric patients with cerebral palsy who will undergo soft tissue surgeries for knee and ankle deformities correction. Methods: This study patients will be randomly distributed to 2 Groups to receive either US guided caudal block or US subgluteal sciatic nerve block after induction of general anesthesia.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• The time till the first postoperative analgesia demand

  within 24 hours after surgery

Secondary Outcomes (14)

• Postoperative revised FLACC scores

  2 hours postoperative

• Postoperative revised FLACC scores

  4 hours postoperative

• Postoperative revised FLACC scores

  6 hours postoperative

• Postoperative revised FLACC scores

  8 hours postoperative

• Postoperative revised FLACC scores

  10 hours postoperative

Study Arms (2)

ultrasound guided Subgluteal sciatic nerve block group

ACTIVE COMPARATOR

using 0.25% bupivacaine ( 0.3ml/Kg )

Procedure: ultrasound guided Subgluteal sciatic nerve block

ultrasound guided Caudal block group

ACTIVE COMPARATOR

using 0.25% bupivacaine ( 1ml/Kg)

Procedure: ultrasound guided Caudal block

Interventions

ultrasound guided Subgluteal sciatic nerve block PROCEDURE

Patients will be positioned in lateral decubitus and the ultrasound scanning for the sciatic nerve in the subgluteal region will be started between the two bony landmarks (greater trochanter and ischial tuberosity ) using high frequency linear probe then approached via 5 cm block needle under ultrasound guidance after which bupivacaine 0.25% (0.3 ml/kg) will be administered in increments .

ultrasound guided Subgluteal sciatic nerve block group

ultrasound guided Caudal block PROCEDURE

Patients will be positioned in lateral decubitus and their sacral hiatus will be palpated under the scanning of the ultrasound using high frequency linear probe then approached via 5 cm block needle that pierce the sacrococcygeal ligament then will be advanced to caudal canal under ultrasound guidance after which bupivacaine 0.25% (1 ml/kg) will be administered in increments.

ultrasound guided Caudal block group

Eligibility Criteria

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

You may qualify if:

• Patient with spastic cerebral palsy
• Age 2 -12 years
• Both gender
• ASA ( American society of anesthesiologists) physical status II

You may not qualify if:

• Parents' refusal to study participation.
• Patients with dyskinetic or ataxic cerebral palsy
• Patients need surgery for hip contracture/deformity
• Severe mental dysfunction
• Poor controlled epilepsy
• Advanced respiratory,renal or hepatic impairment
• Allergy to study medications
• Block contraindication as skin infection near to the block site, gross deformities and bleeding disorders.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Abassia

Cairo, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia , Intensive care and pain management

Study Record Dates

• First Submitted: March 4, 2023
• First Posted: March 17, 2023
• Study Start: March 20, 2023
• Primary Completion: September 27, 2023
• Study Completion: September 27, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)