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Clinical Trials/NCT05284734
NCT05284734
Completed
Not Applicable

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

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization1 site in 1 country60 target enrollmentJanuary 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Circumcision
Sponsor
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Enrollment
60
Locations
1
Primary Endpoint
Level of Postoperative pain
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

Caudal block (CB), a regional anesthesia technique, is the most commonly used neuraxial block method for postoperative pain control in sub-umbilical surgeries in children. However, peripheral nerve blocks have been reported to be preferred in recent years in the literature since they provide longer and safer analgesia. One of these blocks, the erector spina plane (ESP) block, has been shown to provide effective postoperative analgesia when administered from the lumbar level for sacral and lower abdominal surgeries and urogenital surgeries in pediatric patients.

Detailed Description

Circumcision and any lower abdominal surgery in the pediatric population result in a very painful postoperative period, even when each procedure is evaluated separately. Caudal block (CB), a regional anesthesia technique, is the most commonly used neuraxial block method for postoperative pain control in sub-umbilical surgeries in children. However, peripheral nerve blocks have been reported to be preferred in recent years in the literature since they provide longer and safer analgesia. One of these blocks, the erector spina plane (ESP) block, has been shown to provide effective postoperative analgesia when administered from the lumbar level for sacral and lower abdominal surgeries and urogenital surgeries in pediatric patients. As far as we know, there is no previous study in the literature comparing CB and ESP block in pediatric patients.

Registry
clinicaltrials.gov
Start Date
January 1, 2021
End Date
December 15, 2021
Last Updated
4 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 and unilateral lower abdominal surgery at the same session
  • 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

Level of Postoperative pain

Time Frame: Up to 24 hours

It was assessed seven times after the operation with Face, Legs, Activity, Cry, Consolability (FLACC) scale. The lowest scale score is 0 points and the highest 10 points. Following transfer from the recovery unit to the ward, the 1st, 2nd, 4th, 6th, 12th and 24th hour pain levels were evaluated by the ward nurse.

Secondary Outcomes

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

Study Sites (1)

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