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

July 18, 2024 updated by: Bilge Olgun Keles, Giresun University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Central
      • Gi̇resun, Central, Turkey, 28100
        • Giresun Research and Training Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SESPB
Participants received ultrasound-guided SESPB before the surgery
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
Active Comparator: CAUDAL
Participants received ultrasound-guided caudal block before the surgery
Procedure: Ultrasound-guided caudal block
Patients were received ultrasound-guided caudal block, 1ml/kg %0.25 bupivacaine (max 20 ml), for postoperative pain management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Face, Leg, Activity, Cry, Consolability (FLACC) score
Time Frame: 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.
baseline ,and 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analgesic requirement
Time Frame: baseline, and 24 hours
If the FLACC>4 and above rescue analgesics will be made
baseline, and 24 hours
Satisfaction of the patient's parents
Time Frame: 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
24. hours
Satisfaction of the surgeons
Time Frame: 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
24.hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Giresun University

Investigators

  • Study Chair: Elvan Tekir Yılmaz, Giresun University
  • Principal Investigator: Bilge Olgun Keleş, Giresun University
  • Study Chair: Dilek Yeniay, Giresun University
  • Study Chair: İlke Tamdoğan, Giresun University
  • Study Chair: Mehmet Değermenci, Giresun University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2024

Primary Completion (Actual)

June 22, 2024

Study Completion (Actual)

July 18, 2024

Study Registration Dates

First Submitted

April 15, 2024

First Submitted That Met QC Criteria

April 17, 2024

First Posted (Actual)

April 18, 2024

Study Record Updates

Last Update Posted (Actual)

July 22, 2024

Last Update Submitted That Met QC Criteria

July 18, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023/21

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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