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

NCT05688813 | Completed

• 1 other identifier: 2021.51
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Conditions

Postoperative Pain; Children, Only

Keywords

Ultrasound; Pain; Sacral erector spinae block; Caudal block

Outcome Measures

Primary Outcomes (1)

• 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

  Up to 24 hours

Secondary Outcomes (2)

• Time of Postoperative analgesic requirement

  Up to 24 hours

• Rate of Postoperative complications

  Up to 6 hours

Study Arms (2)

Caudal block group

EXPERIMENTAL

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

Sacral erector spinae block

EXPERIMENTAL

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

Interventions

Regional anesthesia intervention PROCEDURE

Ultrasound-guided caudal and sacral erector spinae blocks were administered

Caudal block group; Sacral erector spinae block

Eligibility Criteria

• Age: 1 Year - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization: lead

Study Sites (1)

Prof. Dr. Cemil Tascioglu City Hospital

Istanbul, 34384, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 30851499 BACKGROUND

• 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.

  PMID: 32791500 BACKGROUND

• 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.

  PMID: 32928996 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: A nurse was blinded to collect the pain score. An anesthesiologist was blinded to data collection about the analgesic requirements and postoperative complications.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: January 18, 2023
• Study Start: May 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: May 30, 2022
• Last Updated: January 18, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)