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Clinical Trials/NCT05688813
NCT05688813
Completed
Not Applicable

Comparison of Caudal Block and Sacral Erector Spinae Block for Postoperative Analgesia in Circumcision in Pediatric Patients: A Double-blind, Randomized Controlled Trial

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization1 site in 1 country150 target enrollmentMay 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative Pain
Sponsor
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Enrollment
150
Locations
1
Primary Endpoint
Analgesic efficiency
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Caudal block (CB) has been the method used for years to achieve adequate postoperative analgesia in pediatric patients, which is one of the main responsibilities of an anesthetist. CB, which has been proven to provide effective analgesia for many different indications, is the most commonly performed neuraxial block technique for postoperative pain control in urogenital surgeries. However, in the following years, truncal nerve blocks are recommended for postoperative analgesia by the literature both for more effective analgesia and for preventing complications of CB that may prevent early mobilization and prolong hospital discharge

Detailed Description

Circumcision, which is widely performed in male children for cultural and religious reasons in our country, is one of the daily urological surgical procedures with painful postoperative period. However, in the following years, truncal nerve blocks are recommended for postoperative analgesia by the literature both for more effective analgesia and for preventing complications of CB that may prevent early mobilization and prolong hospital discharge. Based on this knowledge, in order to provide postoperative analgesia in urogenital surgeries in male children sacral ESP (SESP) block can be used as an alternative to CB due to its undesirable effects

Registry
clinicaltrials.gov
Start Date
May 1, 2021
End Date
May 30, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Responsible Party
Principal Investigator
Principal Investigator

Volkan Ozen

Associate Professor

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Eligibility Criteria

Inclusion Criteria

  • 1-7 years of age
  • ASA (American Society of Anesthesiologists) I-II group
  • Scheduled for circumcision
  • Able to communicate in Turkish
  • Willing to participate to the study (parents and children)

Exclusion Criteria

  • Less than 1 or more than 7 years of age
  • A neurological deficit, bleeding diathesis, or a history of local anesthetic allergy; an infection or redness in the injection area, congenital lumbar anomaly, liver and/or kidney disorder, a psychiatric disorder, mental retardation, or communication problems detected during examination
  • Unwilling to to participate to the study ((parents or children)

Outcomes

Primary Outcomes

Analgesic efficiency

Time Frame: Up to 24 hours

The analgesic efficacy was evaluated based on postoperative pain scores via Face, Legs, Activity, Cry, Consolability (FLACC) scale. The lowest scale score is 0 points and the highest 10 points

Secondary Outcomes

  • Time of Postoperative analgesic requirement(Up to 24 hours)
  • Rate of Postoperative complications(Up to 6 hours)

Study Sites (1)

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