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临床试验/CTRI/2024/03/064341
CTRI/2024/03/064341
尚未招募
4 期

Comparison among Ultrasound guided Pudendal Nerve Block Dorsal Penile Nerve Block and Caudal Block for perioperative analgesia on pediatric patients undergoing penile surgeries

All India Institute Of Medical Sciences Patna1 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2024年3月29日最近更新:

概览

阶段
4 期
状态
尚未招募
发起方
All India Institute Of Medical Sciences Patna
入组人数
114
试验地点
1
主要终点
To evaluate postoperative pain scores during 24 hours at different time points (0h, 2h,

概览

简要总结

Pediatric penile surgery done under general anesthesia requires adequate analgesia. Selecting an efficient regional anesthesia for penile surgery on pediatric patients is crucial for lowering postoperative discomfort, cutting down on systemic opioid use and promoting early recovery. We expect to find out the optimal regional anesthesia/nerve block method in the peri operative period for pediatric patients undergoing penile surgeries.

After premedication with midazolam 0.1mg/kg, the patients will be taken into the operating room for application of all ASA monitoring and anesthesia induction will be achieved with Fentanyl (2mcg/kg), Propofol (2mg/kg) & sevoflurane in titrated dose. Laryngeal Mask Airways or Endotracheal tube of the appropriate size to be inserted after muscle relaxant administration as Atracurium (0.5mg/kg).

In Dorsal Penile nerve block group (A- group/ DPNB), Dorsal penile nerve will be achieved in the supine position. After skin sterilization, by using linear probe putting on the symphysis pubis & perforating the Scarpa’s fascia with 25G needle under ultrasound guided technique, injecting 0.25% bupivacaine mixture of 0.3ml/kg volume on the midline into the dorsal base of penis, between the pubis and the penis under Scarpa’s fascia.

In Pudendal nerve block group (B- group/ PDNB), block will be performed in lithotomy position. After the appropriate skin sterilization 22-24G needle, 50-100 mm will be inserted under ultrasound guided technique from inferomedial aspect of ischial tuberosities. Inj. Bupivacaine will be administered as a 0.25% mixture of 0.3ml/kg. This procedure will be performed bilaterally. In Caudal block group (C-group/ CDB), caudal block will be performed under ultrasound guided technique in the lateral decubitus position, the sacral hiatus area will be sterilized with an antiseptic solution and a 24G needle will be used for puncture. Local anesthetics inj. Bupivacaine 0.25% will be given as 0.5ml/kg after confirming the absence of blood and cerebrospinal fluid by aspiration.

The FLACC pain scale will be used to gauge the patients’ level of discomfort. The FLACC postoperative scores at 0 minutes, 2 hour, 4 hours, 6 hours, 12 hours and 24 hours will be noted. Paracetamol 15 mg/kg will be given intravenously at an interval of 6 hours, the first dose to be given intraoperatively. A rescue analgesic to patients will be administered with a score of more than 4, in the form of Inj. Tramadol 1-1.5 mg/kg. In case the analgesia is still inadequate after 30 minutes, inj. Morphine 0.05 mg/kg will be given as and the three techniques will be compared based on FLACC pain scale and with regard to analgesic consumption.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
1.00 Year(s) 至 7.00 Year(s)(—)
性别
Male

入选标准

  • 1-7 years of age ASA I-II Undergoing elective surgery.

排除标准

  • Patients with known allergies to the study drug Coagulopathy Patients with neurological disorders Patients with spinal deformities Emergency surgeries.

结局指标

主要结局

To evaluate postoperative pain scores during 24 hours at different time points (0h, 2h,

时间窗: 0h, 2h, 4h, 6h, 12h, 24h

4h, 6h, 12h, 24h) using FLACC pain scale (Face, Leg, Activity, Cry and Consolability)

时间窗: 0h, 2h, 4h, 6h, 12h, 24h

delivering postoperative analgesia.

时间窗: 0h, 2h, 4h, 6h, 12h, 24h

次要结局

  • To assess perioperative opioid consumption among the three groups during 24 hours(within 24 hours)
  • Time to first rescue analgesia(within 24 hours)
  • To assess parent’s satisfaction with perioperative analgesia(after 24 hours)

研究者

发起方
All India Institute Of Medical Sciences Patna
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Saikat Das

AIIMS Patna

研究点 (1)

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