Clinical trial NCT05688813: Comparison of Caudal Block and Sacral Erector Spinae Block for Postoperative Analgesia
Official title: Comparison of Caudal Block and Sacral Erector Spinae Block for Postoperative Analgesia in Circumcision in Pediatric Patients: A Double-blind, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Children, Only
Keywords: Ultrasound
Pain
Sacral erector spinae block
Caudal block
Lead sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Sponsor class: OTHER
First posted: 2023-01-18
Enrollment: 150
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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)

Primary outcomes:
measure: Analgesic efficiency
timeFrame: Up to 24 hours
Secondary outcomes:
measure: Time of Postoperative analgesic requirement
timeFrame: Up to 24 hours
measure: Rate of Postoperative complications
timeFrame: Up to 6 hours
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Prof. Dr. Cemil Tascioglu City Hospital
Study officials:
References:
citation: Aksu C, Sen MC, Akay MA, Baydemir C, Gurkan Y. Erector Spinae Plane Block vs Quadratus Lumborum Block for pediatric lower abdominal surgery: A double blinded, prospective, and randomized trial. J Clin Anesth. 2019 Nov;57:24-28. doi: 10.1016/j.jclinane.2019.03.006. Epub 2019 Mar 6.
citation: Ozen V, Yigit D. A Comparison of the Postoperative Analgesic Effectiveness of Ultrasound-Guided Dorsal Penile Nerve Block and Ultrasound-Guided Pudendal Nerve Block in Circumcision. Urol Int. 2020;104(11-12):871-877. doi: 10.1159/000509173. Epub 2020 Aug 13.
citation: Desai N, Chan E, El-Boghdadly K, Albrecht E. Caudal analgesia versus abdominal wall blocks for pediatric genitourinary surgery: systematic review and meta-analysis. Reg Anesth Pain Med. 2020 Nov;45(11):924-933. doi: 10.1136/rapm-2020-101726. Epub 2020 Sep 14.