Comparison of Caudal Block and Erector Spinae Block for Postoperative Analgesia

Circumcision Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05284734
• Other study ID #: 2021.42
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: December 15, 2021

Study information

• Verified date: March 2022
• Source: Prof. Dr. Cemil Tascioglu Education and Research Hospital Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 15, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 7 Years

Eligibility

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)

Related Conditions & MeSH terms

• Circumcision
• Lower Abdominal Surgery

Intervention

Procedure:
• Regional anesthesia intervention
Ultrasound-guided caudal and erector spinae blocks were administered

Locations

Country	Name	City	State
Turkey	Prof. Dr. Cemil Tascioglu City Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Dr. Cemil Tascioglu Education and Research Hospital Organization

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of Postoperative pain	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.	Up to 24 hours
Secondary	Time of Postoperative analgesic requirement	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. Significant pain behavior for the scale has been identified as 4 points or more. Following transfer from the recovery unit to the ward, the 1st, 2nd, 6th, 12th and 24th 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.	Up to 24 hours
Secondary	Rate of Postoperative complications	Urinary retention, hematoma, ecchymosis, motor block were postoperative complications. They were assessed by an anesthesiologist.	Up to 24 hours