"Comparison of Analgesic Effects of USG-Guided Caudal Versus Ilioinguinal/Iliohypogastric Nerve Block Techniques for Inguinal Surgeries in Children, a Randomized Controlled Trial."
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Degree of pain relief
研究概览
简要总结
This study is designed to compare the analgesic effectiveness of caudal analgesia to ilioinguinal regional analgesia techniques in children undergoing inguinal surgeries. Both techniques will be done under ultrasound gaudiness, using the same local anesthesia. 128 patients will be included in this study, 64 for each technique. This study aims to know the best regional analgesia technique in children undergoing inguinal surgeries, reduction in rescue analgesia postoperatively, postoperative length of stay, and early resumption of postoperative activity.
The patients will be followed up 30 minutes after the end of anesthesia in PACU, postoperatively in Ward at 2 Hours, 3 hours, 6 hours from the end of anesthesia, and or at the time of discharge from the ward & on days 2 and 7. Patient privacy and safety will be respected at all times. An interim analysis will be done after recruiting 25% of cases (16 cases) in both arms. Once the sample size is reached, the data will be sent for statistical analysis with coded patient identity.
Based on study findings, the practice will be optimized with the aim of improvement in pain relief, reduction in opioid requirements, and enhanced recovery after surgery (ERAS), reducing the bed occupancy time in the hospital.
详细描述
Introduction Inguinal surgeries are commonly performed in children. Pain is a dreaded side effect of any surgery and should be adequately assessed and treated. It has been shown that even minor procedures can cause significant pain in children.
- Assessment of adequate analgesia is complex in children. Inadequate analgesia can cause neurological, metabolic, pulmonary, and other bodily effects.
- Postoperative analgesia for inguinal surgeries can be provided with caudal and ilioinguinal/iliohypogastric nerve blocks. These techniques are safe and reduce the requirement for opioids postoperatively. This can help in early discharge from the hospital and faster resumption of daily activities.
The caudal block involves an injection of local anesthetic agents into the caudal space. The caudal space is the sacral portion of epidural space involving needle penetration of sacrococcygeal ligament covering sacral hiatus. This block is commonly done to provide analgesia for urogenital, rectal, and inguinal surgeries. This block was primarily performed as a blind technique. The onset of action is typically in 8.8 minutes, as per NYSORA guidelines. Fortunately, serious complications occur infrequently. Potential complications include epidural abscess, meningitis, epidural hematoma, dural puncture, post-dural puncture headache, subdural injection, pneumocephalus, air embolism, back pain, and intracranial hypotension headache after uncomplicated caudal epidural injection. Ilioinguinal/iliohypogastric nerve block is commonly performed for inguinal surgeries. This nerve penetrates the transversus abdominis muscle above the iliac crest and supplies the muscle, and provides cutaneous innervation to the skin of the scrotum and adjacent thigh. This block is known to abolish pain following inguinal surgeries in the pediatric population effectively.
The primary objective of the study is to find a better analgesia technique out of caudal and ilioinguinal/iliohypogastric blocks. The secondary objective is to compare the reduction in the use of rescue analgesics and find a technique that provides earlier resumption of activities.
Methods:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The participant (patient) and the outcome assessor will be masked. Whereas the investigator who performs the block will not be masked.
入排标准
- 年龄范围
- 6 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 6 months to 12 years
- •ASA I and II
- •Type of surgery (Inguinal surgeries)
排除标准
- •Refusal of consent
- •ASA III and higher risk group
- •Hemodynamically unstable
- •Local infection over the insertion site
- •Coagulopathy
- •Known allergy to Local Anaesthetic medications
- •Difficult anatomy
结局指标
主要结局
Degree of pain relief
时间窗: upto 1-2 days
Degree of analgesia will be checked postoperatively at 30 minutes after anesthesia in PACU, postoperatively in ward at 2, 3 and 6 hours from end of anesthesia and or at time of discharge from ward whichever is earlier.
次要结局
- Change in use of rescue analgesia postoperatively(upto 1-2 days)