Clinical trial NCT05284734: Comparison of Caudal Block and Erector Spinae Block for Postoperative Analgesia
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Circumcision
Lower Abdominal Surgery
Keywords: Ultrasound
Pain
Caudal block
Erector spinae block
Lead sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Sponsor class: OTHER
First posted: 2022-03-17
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: Level of Postoperative pain
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 24 hours
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Prof. Dr. Cemil Tascioglu City Hospital
Study officials:
affiliation: Prof. Dr. Cemil Tascıoglu City Hospital
name: Volkan Özen, Asso.Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tulgar S, Selvi O, Senturk O, Serifsoy TE, Thomas DT. Ultrasound-guided Erector Spinae Plane Block: Indications, Complications, and Effects on Acute and Chronic Pain Based on a Single-center Experience. Cureus. 2019 Jan 2;11(1):e3815. doi: 10.7759/cureus.3815.
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: Ozen V, Yigit D. Caudal epidural block versus ultrasound-guided dorsal penile nerve block for pediatric distal hypospadias surgery: A prospective, observational study. J Pediatr Urol. 2020 Aug;16(4):438.e1-438.e8. doi: 10.1016/j.jpurol.2020.05.009. Epub 2020 May 20.