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

NCT06373185 | Completed

• 1 other identifier: 2023/21
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Urogenital Diseases; Nerve Block; Pain, Postoperative

Keywords

sacral erector spinae plane block; caudal block; nerve block; anesthesia, general; urogenital surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Analgesic requirement

  baseline, and 24 hours

• Satisfaction of the patient's parents

  24. hours

• Satisfaction of the surgeons

  24.hours

Study Arms (2)

SESPB

EXPERIMENTAL

Participants received ultrasound-guided SESPB before the surgery

Procedure: Ultrasound-guided sacral erector spinae plane block

CAUDAL

ACTIVE COMPARATOR

Participants received ultrasound-guided caudal block before the surgery

Procedure: Ultrasound-guided caudal block

Interventions

Ultrasound-guided sacral erector spinae plane block PROCEDURE

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

SESPB

Ultrasound-guided caudal block PROCEDURE

Patients were received ultrasound-guided caudal block, 1ml/kg %0.25 bupivacaine (max 20 ml), for postoperative pain management

CAUDAL

Eligibility Criteria

• Age: 1 Year - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Giresun University: lead

Study Sites (1)

Giresun Research and Training Hospital

Giresun, Central, 28100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urogenital Diseases; Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Officials

• Bilge Olgun Keleş

  Giresun University

  PRINCIPAL INVESTIGATOR

• Dilek Yeniay

  Giresun University

  STUDY CHAIR

• Elvan Tekir Yılmaz

  Giresun University

  STUDY CHAIR

• İlke Tamdoğan

  Giresun University

  STUDY CHAIR

• Mehmet Değermenci

  Giresun University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Randomisation using a closed envelope method based on computer-generated random numbers was to assign patients to two equal groups. Group 1 received midline US-guided sacral erector spinae plane block and Group 2 received caudal block. The experienced anesthetist who opened the envelope performed the block according to the group code and patients were followed postoperatively by an anesthetist blinded to which block was performed. Patients were also blinded as to which block was performed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized controlled double blind study

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 18, 2024
• Study Start: April 22, 2024
• Primary Completion: June 22, 2024
• Study Completion: July 18, 2024
• Last Updated: July 22, 2024

Record last verified: 2024-07

Locations

TU (1)