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

Pain, Postoperative Clinical Trial

— SESPB  

Official title:

Comparison of the Effects of Sacral Erector Spinae Plane Block and Caudal Block on Postoperative Pain Control in Pediatric Urogenital Surgery Cases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06373185
• Other study ID #: 2023/21
• Status: Recruiting
• Phase: N/A
• Start date: April 22, 2024
• Est. completion date: June 2024

Study information

• Verified date: April 2024
• Source: Giresun University
• Contact: Bilge Olgun Keles
• Phone: 05317338805
• Email: bilge.olgun[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Nerve Block
• Pain, Postoperative
• Urogenital Diseases

Intervention

Procedure:
• Ultrasound-guided sacral erector spinae plane block
Patients were received ultrasound-guided sacral erector spinae plane block, 1ml/kg %0.25 bupivacaine (max 20 ml), for postoperative pain management
• Ultrasound-guided caudal block
Patients were received ultrasound-guided caudal block, 1ml/kg %0.25 bupivacaine (max 20 ml), for postoperative pain management

Locations

Country	Name	City	State
Turkey	Giresun Research and Training Hospital	Gi?resun	Central

Sponsors (1)

Lead Sponsor	Collaborator
Giresun University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Face, Leg, Activity, Cry, Consolability (FLACC) score	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.	baseline ,and 24 hours
Secondary	Analgesic requirement	If the FLACC>4 and above rescue analgesics will be made	baseline, and 24 hours
Secondary	Satisfaction of the patient's parents	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	24. hours
Secondary	Satisfaction of the surgeons	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	24.hours