Comparison of the Efficacy of Sacral Espb and Caudal Block for Pain Management After Urogenital Surgeries in Children

Not Applicable

Completed

• Conditions: Pain, Postoperative; Urogenital Diseases; Nerve Block
• Interventions: Procedure: Ultrasound-guided caudal block; Procedure: Ultrasound-guided sacral erector spinae plane block

• Registration Number: NCT06373185
• Lead Sponsor: Giresun University

Brief Summary

The aim of this study was to compare the efficacy of caudal block and sacral espb used as a postoperative analgesia method in urogenital pediatric surgery cases.

Detailed Description

The parents of the patients who will undergo urogenital surgery will be included in the study after being informed and written consent is obtained. They will be randomised and divided into two groups. After general anaesthesia, sacral espb will be performed in the 1st group and caudal block will be performed in the 2nd group and postoperative pain will be evaluated with Face, Leg, Activity, Cry, Consolability (FLACC) score.

Study Timeline

• Study First Submitted: 2024-04-15
• Study First Submitted QC: 2024-04-17
• Study First Posted: 2024-04-18
• Study Start: 2024-04-22
• Primary Completion: 2024-06-22
• Status Verified: 2024-07
• Study Completion: 2024-07-18
• Last Update Submitted: 2024-07-18
• Last Update Posted: 2024-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients aged 1-7 years undergoing paediatric urogenital surgery
• Patients in American Society of Anesthesiologist (ASA) class I-II

Exclusion Criteria

• Patients whose parents do not give consent
• Patients with anatomical changes in the sacral region, previous surgery, scar and infection,
• Patients with known local anaesthetic allergy
• Patients for whom regional anaesthesia is contraindicated
• Known neurological or muscular disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CAUDAL	Ultrasound-guided caudal block	Participants received ultrasound-guided caudal block before the surgery
SESPB	Ultrasound-guided sacral erector spinae plane block	Participants received ultrasound-guided SESPB before the surgery

Primary Outcome Measures

Name	Time	Method
Face, Leg, Activity, Cry, Consolability (FLACC) score	baseline ,and 24 hours	The FLACC is an observational pain scale. It is widely used in the paediatric population to assess pain in infants and children who are unable to verbally express their pain.Each category is scored on the 0-2 scale which results in a total score of 0-10.

Secondary Outcome Measures

Name	Time	Method
Analgesic requirement	baseline, and 24 hours	If the FLACC\>4 and above rescue analgesics will be made
Satisfaction of the patient's parents	24. hours	A questionnaire will be used in which patient's parents will indicate their satisfaction from 0 to 10. 0: not at all satisfied, 10: very satisfied
Satisfaction of the surgeons	24.hours	A questionnaire will be used in which surgeon's will indicate their satisfaction from 0 to 10. 0: not at all satisfied, 10: very satisfied

Trial Locations

Locations (1)

Giresun Research and Training Hospital; 🇹🇷 Gi̇resun, Central, Turkey