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

NCT ID: NCT05688813

Last Updated: 2023-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2022-05-30

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

Conditions

Postoperative Pain; Children, Only

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Regional anesthesia intervention

Intervention Type: PROCEDURE

Ultrasound-guided caudal and sacral erector spinae blocks were administered

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.

Group Type: EXPERIMENTAL

Regional anesthesia intervention

Intervention Type: PROCEDURE

Ultrasound-guided caudal and sacral erector spinae blocks were administered

Interventions

Regional anesthesia intervention

Ultrasound-guided caudal and sacral erector spinae blocks were administered

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

OTHER

Sponsor Role: lead

Responsible Party

Volkan Ozen

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Prof. Dr. Cemil Tascioglu City Hospital

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 30851499 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32791500 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32928996 (View on PubMed)

Other Identifiers

2021.51

Identifier Type: -

Identifier Source: org_study_id