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

Sponsor

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization (Other)

Overall Status

Completed

CT.gov ID

NCT05688813

Collaborator

(none)

150

Enrollment

Location

Arms

12.9

Actual Duration (Months)

11.6

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain Children, Only	Procedure: Regional anesthesia intervention	N/A

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

Study Design

Study Type:

Interventional

Actual Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Care Provider, Outcomes Assessor)

Masking Description:

A nurse was blinded to collect the pain score. An anesthesiologist was blinded to data collection about the analgesic requirements and postoperative complications.

Primary Purpose:

Prevention

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

Actual Study Start Date :

May 1, 2021

Actual Primary Completion Date :

May 1, 2022

Actual Study Completion Date :

May 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Caudal block group An echogenic block needle (22 Gauge 50 mm) was then advanced into the sacral canal through the sacrococcygeal membrane while a longitudinal position was used, continuing with the in-plane technique. After ensuring that there is no blood or cerebrospinal fluid with aspiration, 0.5 ml/kg 0.25% bupivacaine was administered while observing caudal epidural space dilation or turbulent flow with Doppler.	Procedure: Regional anesthesia intervention Ultrasound-guided caudal and sacral erector spinae blocks were administered
Experimental: Sacral erector spinae block Following antiseptic preparation of block site linear ultrasound probe was placed longitudinally to midline just above the sacrum. After the median sacral crests and erector spinae were identified, a 22G, 50 mm block needle was advanced from the cranial to the caudal direction until it touched the top of the 4th median sacral crest with the in-plane technique. After hydrodissection was achieved with 1 ml of saline, 0.5 ml/kg of 0.25% bupivacaine was administered after negative aspiration.	Procedure: Regional anesthesia intervention Ultrasound-guided caudal and sacral erector spinae blocks were administered

Arm

Intervention/Treatment

Experimental: Caudal block group

An echogenic block needle (22 Gauge 50 mm) was then advanced into the sacral canal through the sacrococcygeal membrane while a longitudinal position was used, continuing with the in-plane technique. After ensuring that there is no blood or cerebrospinal fluid with aspiration, 0.5 ml/kg 0.25% bupivacaine was administered while observing caudal epidural space dilation or turbulent flow with Doppler.

Procedure: Regional anesthesia intervention

Ultrasound-guided caudal and sacral erector spinae blocks were administered

Experimental: Sacral erector spinae block

Following antiseptic preparation of block site linear ultrasound probe was placed longitudinally to midline just above the sacrum. After the median sacral crests and erector spinae were identified, a 22G, 50 mm block needle was advanced from the cranial to the caudal direction until it touched the top of the 4th median sacral crest with the in-plane technique. After hydrodissection was achieved with 1 ml of saline, 0.5 ml/kg of 0.25% bupivacaine was administered after negative aspiration.

Procedure: Regional anesthesia intervention

Ultrasound-guided caudal and sacral erector spinae blocks were administered

Outcome Measures

Primary Outcome Measures

Analgesic efficiency [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 Outcome Measures

Time of Postoperative analgesic requirement [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
Rate of Postoperative complications [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 7 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)