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

Primary Purpose

Postoperative Pain, Children, Only

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Regional anesthesia intervention
Sponsored by
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain focused on measuring Ultrasound, Pain, Sacral erector spinae block, Caudal block

Eligibility Criteria

1 Year - 7 Years (Child)All SexesDoes not accept 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)

Sites / Locations

  • Prof. Dr. Cemil Tascioglu City Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Caudal block group

Sacral erector spinae block

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Analgesic efficiency
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
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
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

Full Information

First Posted
January 9, 2023
Last Updated
January 9, 2023
Sponsor
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
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1. Study Identification

Unique Protocol Identification Number
NCT05688813
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
May 1, 2022 (Actual)
Study Completion Date
May 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Children, Only
Keywords
Ultrasound, Pain, Sacral erector spinae block, Caudal block

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes 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.
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Caudal block group
Arm Type
Experimental
Arm Description
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.
Arm Title
Sacral erector spinae block
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Regional anesthesia intervention
Intervention Description
Ultrasound-guided caudal and sacral erector spinae blocks were administered
Primary Outcome Measure Information:
Title
Analgesic efficiency
Description
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
Time Frame
Up to 24 hours
Secondary Outcome Measure Information:
Title
Time of Postoperative analgesic requirement
Description
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
Time Frame
Up to 24 hours
Title
Rate of Postoperative complications
Description
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
Time Frame
Up to 6 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Prof. Dr. Cemil Tascioglu City Hospital
City
Istanbul
ZIP/Postal Code
34384
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30851499
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.
Results Reference
background
PubMed Identifier
32791500
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.
Results Reference
background
PubMed Identifier
32928996
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.
Results Reference
background

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

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