Comparison of the Effects of Caudal Block and Retrolaminar Block on Analgesic Consumption in Postoperative Pain Management for Pediatric Undescended Testis Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Postoperative Pain Scores
研究概览
简要总结
This study compares the postoperative analgesic effectiveness of Caudal Block (CB) and Retrolaminar Block (RLB) in pediatric patients undergoing undescended testis surgeries. Both techniques aim to manage pain effectively and reduce reliance on systemic analgesics, improving recovery and minimizing complications.
The double-blind, randomized controlled trial will include 1-7-year-old ASA I-II patients at two hospitals. Patients with specific contraindications (e.g., spinal anomalies, allergies, or infections) will be excluded. Randomization divides participants into two groups (CB and RLB), with pain assessments performed using the FLACC pain scale by a blinded nurse.
Procedures:
CB: 0.125% bupivacaine (1 mL/kg, max 20 mL) injected into the sacral canal under ultrasound guidance.
RLB: 0.25% bupivacaine (0.1 mL/kg) injected into the retrolaminar space at the L4 level under ultrasound guidance.
Postoperative pain will be evaluated at various intervals (30 minutes to 24 hours). Intravenous paracetamol or tramadol will be administered based on pain scores.
The study aims to compare pain scores, time to first analgesic requirement, and postoperative complications, contributing valuable data on these two regional anesthesia techniques in pediatric surgery.
详细描述
Pediatric lower abdominal surgeries, especially undescended testis surgeries, are procedures that can cause significant pain in the postoperative period. Effective pain management in such surgeries is crucial to accelerate recovery in children and reduce complications associated with analgesic medications. Among the most commonly used regional anesthesia techniques for pediatric lower abdominal surgeries is the caudal block, which has provided effective pain management for many years. However, in recent years, ultrasound-guided trunkal nerve blocks have gained popularity due to their targeted and prolonged analgesic effects. One such block, the retrolaminar block (RLB), is a relatively new technique applied around the spinal laminae with local anesthetics and has been increasingly utilized in pediatric surgeries.
While the caudal block is widely used in lower abdominal surgeries, ensuring proper distribution of the anesthetic agent and monitoring for potential side effects during the procedure is necessary. In contrast, the retrolaminar block, performed reliably under ultrasound guidance, is suggested to provide longer-lasting analgesia compared to the caudal block. The RLB allows for broader spread of the local anesthetic in the paraspinal region, potentially affecting both lower and upper areas. However, studies comparing the postoperative analgesic effects of RLB and caudal block in pediatric patients are quite limited in the literature.
This study aims to compare the postoperative analgesic effectiveness of caudal block and retrolaminar block in pediatric patients undergoing undescended testis surgeries. The study evaluates differences between these two regional anesthesia techniques in terms of postoperative pain scores, time to first analgesic requirement, and postoperative complications. The limited data available on these block methods in the literature highlight the potential scientific contribution of this study.
This double-blind, randomized controlled trial will be conducted at Prof. Dr. Cemil Taşçıoğlu City Hospital and Zincirlikuyu Medicana Hospitals. Following clinical ethics committee approval, the study will include pediatric patients aged 1 to 7 years who are classified as ASA I-II and scheduled for unilateral undescended testis surgeries.
Patients under 1 year or over 7 years, those with neurological deficits, bleeding disorders, a history of allergies to local anesthetics, signs of redness or infection at the injection site during physical examination, congenital spinal anomalies, mental retardation, psychiatric disorders, liver or kidney disease, and those who do not consent to participate will be excluded from the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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 1-7 years. ASA (American Society of Anesthesiologists) physical status I or II. Scheduled for unilateral undescended testis surgery. Parental/guardian consent provided for study participation.
排除标准
- •Age under 1 year or over 7 years. Neurological deficits. Coagulopathy or bleeding disorders. History of allergy to local anesthetics. Signs of redness, infection, or other abnormalities at the injection site. Congenital spinal anomalies. Intellectual disability or psychiatric disorders. Hepatic or renal impairment. Refusal to participate in the study by parents or guardians.
研究组 & 干预措施
Retrolaminar block group
Pediatric patients in this group will receive a retrolaminar block (RLB) using 0.25% bupivacaine (0.1 mL/kg) injected into the retrolaminar space at the L4 vertebral level under ultrasound guidance after general anesthesia induction.
干预措施: Retrolaminar Block (RLB) (Procedure)
Caudal Block (CB) Group
Pediatric patients in this group will receive a caudal block (CB) using 0.125% bupivacaine (1 mL/kg, maximum 20 mL) injected into the sacral canal under ultrasound guidance after general anesthesia induction.
干预措施: Caudal Block (CB) (Procedure)
结局指标
主要结局
Postoperative Pain Scores
时间窗: Up to 24 hours postoperatively.
Assessment of postoperative pain scores using the FLACC scale (Face, Legs, Activity, Cry, Consolability) at predefined intervals (30 minutes, 1, 2, 4, 6, 12, and 24 hours postoperatively). Scores range from 0 to 10, with higher scores indicating greater pain intensity.
次要结局
- Time to First Analgesic Requirement(Up to 24 hours postoperatively.)
- Total Analgesic Consumption(Up to 24 hours postoperatively.)
- Incidence of Postoperative Complications(Up to 24 hours postoperatively.)
研究者
Engin Ihsan Turan
anesthesiology and reanimation specialist
Kanuni Sultan Suleyman Training and Research Hospital
