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
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Analgesic Efficiency
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
盲法说明
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.
入排标准
- 年龄范围
- 1 Year 至 7 Years(Child)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Analgesic Efficiency
时间窗: 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.
次要结局
- Analgesic Requirements:(1 day)
- Postoperative Complications:(1 day)
研究者
Engin Ihsan Turan
DR
Kanuni Sultan Suleyman Training and Research Hospital
