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NCT Number: NCT05688813

Comparison of Caudal Block and Sacral Erector Spinae Block for Postoperative Analgesia

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

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Key information

Conditions

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

Age range

1 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prof. Dr. Cemil Tascioglu City Hospital

Istanbul, 34384, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Regional anesthesia intervention

Procedure

Ultrasound-guided caudal and sacral erector spinae blocks were administered

Primary outcomes

  1. 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

  1. Time of Postoperative analgesic requirement

    Time frame: Up to 24 hours

    It was assessed five times after the operation with Face, Legs, Activity, Cry, Consolability (FLACC) scale. The lowest scale score is 0 points and the highest 10 points. Significant pain behavior for the scale has been identified as 4 points or more. Following transfer from the recovery unit to the ward, the 30 minutes, 1st, 2nd, 4th, and 6th hour pain levels were evaluated by the ward nurse. Paracetamol was administered IV at a dose of 10 mg/kg if the scale score was 4 or higher

  2. Rate of Postoperative complications

    Time frame: Up to 6 hours

    The presence of urinary retention, motor block, and ecchymosis or hematoma at the injection site was evaluated in the postoperative period by the anesthesiologist who was blind to the study groups

Sponsors and collaborators

Lead sponsor

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 18, 2023
Registry last updated
Jan 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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