Comparison of Caudal Block and Retrolaminar Block for Circumcision

NCT06584292 | Withdrawn

• 1 other identifier: retrolaminar blok
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Outcome: Analgesic Efficiency: The primary outcome is the comparison of the analgesic efficacy of the retrolaminar block (RL) versus caudal block (CB) based on postoperative pain scores measured by the FLACC score. This outcome aims to evaluate how effectively each block controls postoperative pain. Secondary Outcomes: Analgesic Requirements: The amount of analgesic required within the first 24 hours postoperatively. The time to the first analgesic requirement. These will be recorded during postoperative follow-up visits at 30 minutes, 1, 2, 4, 6, 12, and 24 hours by an anesthesiologist who is blinded to the study groups. Postoperative Complications: Urinary Retention: Defined as a distended palpable bladder associated with pain. Motor Block: The presence of lower extremity motor block will be evaluated using the modified Bromage scale (0: No motor block; 1: Able to move the legs; 2: Unable to move the legs). Ecchymosis and Hematoma: The presence of ecchymosis (discoloration of the skin due to blood infiltration in the subcutaneous tissues) and hematoma (abnormal swelling or hardening caused by the accumulation of blood) at the injection site will be assessed.

Conditions

Regional Anesthesia

Keywords

Caudal block; Retrolaminar block; postoperative pain management

Outcome Measures

Primary Outcomes (1)

• Analgesic Efficiency

  The primary outcome is the comparison of the analgesic efficacy of the retrolaminar block (RL) versus caudal block (CB) based on postoperative pain scores measured by the Face, Legs, Activity, Cry, Consolability (FLACC) scale. The FLACC scale is used to assess pain in pediatric patients, with scores ranging from 0 to 10. A score of 0 indicates no pain, while a score of 10 represents severe pain. Therefore, higher scores indicate worse pain outcomes. This outcome aims to evaluate how effectively each block controls postoperative pain.

  1 day

Secondary Outcomes (2)

• Analgesic Requirements:

  1 day

• Postoperative Complications:

  1 day

Study Arms (2)

Caudal block

ACTIVE COMPARATOR

Caudal Block (CB) will applied to the patients.

Procedure: caudal block

Retrolaminar Block

ACTIVE COMPARATOR

Retrolaminar Block (RL) will applied to the patients.

Procedure: Retrolaminar block

Interventions

caudal block PROCEDURE

Caudal Block (CB) Procedure: The sacral hiatus was identified using an out-of-plane transverse ultrasound view at the level of the sacral cornua. The probe was then rotated longitudinally to visualize the sacrococcygeal ligament and sacral bone. A block needle was inserted through the sacrococcygeal membrane into the sacral canal using the in-plane technique, and 0.125% bupivacaine was administered at a dose of 1 mL/kg, with a maximum limit of 20 mL per side.

Caudal block

Retrolaminar block PROCEDURE

Retrolaminar Block (RL) Procedure: The RL block was performed with the patient in a lateral decubitus position. The ultrasound probe was positioned at the L4 vertebral level in a paramedian sagittal plane. The probe was moved medially until the vertebral laminae were visualized. The needle was inserted using the in-plane technique, advancing from the cephalad to caudal direction until it contacted the L4 lamina. A dose of 0.1 mL/kg of 0.25% bupivacaine was then injected into the retrolaminar space.

Retrolaminar Block

Eligibility Criteria

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

You may qualify if:

• Pediatric patients aged 1 to 7 years.
• Classified as American Society of Anesthesiologists (ASA) physical status I-II.
• Scheduled for elective, unilateral lower abdominal surgery (e.g., orchiopexy or hydrocelectomy) combined with circumcision.
• Patients whose parents or legal guardians provided written informed consent.

You may not qualify if:

• Patients younger than 1 year or older than 7 years.
• Presence of neurological deficits.
• Bleeding disorders.
• History of allergy to local anesthetic drugs.
• Presence of redness or infection at the injection site on physical examination.
• Any congenital spinal anomalies.
• Intellectual disabilities or psychiatric disorders.
• Liver and/or kidney disease.
• Patients or their guardians who declined to participate in the study.

Sponsors & Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital: lead

Study Sites (1)

Health Science University İstanbul Prof Dr Cemil Taşcıoğlu City Hospital

Istanbul, Okmeydanı, Turkey (Türkiye)

Location

Study Officials

• Volkan Özen, Associate Proffesor

  Health Science University İstanbul Prof Dr Cemil Taşcıoğlu City Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The nurse was blinded to the face, legs, activity, cry, and consolability (FLACC) scores. An anesthesiologist was blinded to data collection regarding analgesic requirement and postoperative complications. Transparent sterile drapes were applied to the injection sites, and both blocks were administered to all patients to evaluate postoperative complications. Thus, the anesthetist was blinded to the postoperative complications.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: September 2, 2024
• First Posted: September 4, 2024
• Study Start: September 27, 2022
• Primary Completion: December 15, 2024
• Study Completion: December 30, 2024
• Last Updated: February 19, 2025

Record last verified: 2025-02

Locations

TU (1)