Skip to main content
Clinical Trials/NCT06584292
NCT06584292WithdrawnNot Applicable

Comparison of Caudal Block and Retrolaminar Block for Postoperative Analgesia in Concurrent Circumcision and Low Abdominal Surgery in Pediatric Patients: A Double-blind, Randomized Controlled Trial

Kanuni Sultan Suleyman Training and Research Hospital1 site in 1 country60 target enrollmentStarted: September 27, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Enrollment
60
Locations
1
Primary Endpoint
Analgesic Efficiency

Study Overview

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.

Detailed Description

This study is a double-blind, randomized controlled trial designed to compare the analgesic efficacy and safety of the retrolaminar block (RL) versus the caudal block (CB) in pediatric patients undergoing concurrent circumcision and lower abdominal surgery. The trial adheres to the ethical principles outlined in the Declaration of Helsinki and was conducted in the Anesthesiology and Reanimation department of a tertiary education and research hospital.

Study Population The study included pediatric patients aged 1 to 7 years who were classified as American Society of Anesthesiologists (ASA) physical status I or II. These patients were scheduled for elective, unilateral lower abdominal surgery (such as orchiopexy or hydrocelectomy) combined with circumcision. The inclusion criteria ensured the selection of otherwise healthy children with no significant comorbidities. Exclusion criteria included patients younger than 1 year or older than 7 years, those with neurological deficits, bleeding disorders, allergy to local anesthetics, infection at the injection site, congenital spinal anomalies, intellectual disabilities, psychiatric disorders, liver and/or kidney diseases, and those who declined to participate.

Randomization and Blinding Participants were randomly assigned to one of two groups (RL block or CB block) using a computer-generated randomization table. The randomization process was designed to ensure an equal distribution of patients across both groups. Both patients and the healthcare professionals involved in postoperative care were blinded to the type of block administered. To maintain blinding, both blocks were performed under sterile conditions, and identical transparent drapes were used to cover the injection sites. An anesthesiologist who was not involved in the block administration was responsible for data collection related to postoperative analgesic requirements and complications.

General Anesthesia Protocol All patients received 0.5 mg/kg of oral midazolam as premedication. In the operating room, standard monitoring was applied, and anesthesia was induced with intravenous (IV) propofol (2 mg/kg) and fentanyl (0.5 µg/kg). After the loss of the eyelash reflex, an appropriately sized laryngeal mask airway (LMA) was placed without the use of neuromuscular blocking agents. Anesthesia was maintained with sevoflurane (2%) in a mixture of 50% oxygen and air. Demographic data, including age, weight, type of surgery, duration of the procedure, and any complications, were recorded.

Regional Anesthesia Procedure Following the induction of general anesthesia and airway management, the patients were placed in the left lateral decubitus position for the regional block procedure. All blocks were performed by a single experienced operator skilled in pediatric ultrasound-guided regional anesthesia, using a 22-G, 50-mm echogenic needle. The ultrasound guidance was provided by a high-frequency (6.5-18 MHz) linear probe.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Double (Participant, Care Provider)

Masking Description

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.

Eligibility Criteria

Ages
1 Year to 7 Years (Child)
Sex
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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.

Exclusion Criteria

  • •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.

Arms & Interventions

Caudal block

Active Comparator

Caudal Block (CB) will applied to the patients.

Intervention: caudal block (Procedure)

Retrolaminar Block

Active Comparator

Retrolaminar Block (RL) will applied to the patients.

Intervention: Retrolaminar block (Procedure)

Outcomes

Primary Outcomes

Analgesic Efficiency

Time Frame: 1 day

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.

Secondary Outcomes

  • Analgesic Requirements:(1 day)
  • Postoperative Complications:(1 day)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Engin Ihsan Turan

principal investigator

Kanuni Sultan Suleyman Training and Research Hospital

Study Sites (1)

Loading locations...

Similar Trials