跳至主要内容
临床试验/CTRI/2025/04/085756
CTRI/2025/04/085756尚未招募Phase 3 4

Ultrasound-guided caudal epidural Versus PENG Block as a part of the opioid-sparing multimodal analgesic regime for pediatric open hip surgery: A comparative prospective Randomized Clinical Trial

Nizams Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年12月5日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
入组人数
70
试验地点
1
主要终点
to evaluate the postoperative pain scores in the first 24 hours after surgery in patients undergoing hip surgery receiving either PENG or caudal epidural block.

研究概览

简要总结

Management of postoperative pain after open hip joint surgery in the pediatric population is often challenging, necessitating the use of systemic opioids.[1]Globally, opioid-sparing strategies and enhanced recovery after surgery programs are making their appearance in pediatric surgical specialties.[2]Regional anesthesia and a robust plan for multimodal analgesia are the primary methods being used to decrease opioid use.[3, 4]

The most frequently used method of regional analgesia in pediatric hip surgery is caudal epidural blocks.[5] However, it is known to be associated with numerous adverse effects like bilateral motor blockade, hypotension, and accidental dural puncture.[6] Regional blocks such as Pericapsullar nerve group (PENG) block in adjuvant with general anesthesia is an alternative perioperative analgesic technique and have been reported in many case series to cause unilateral sensory blockade with an excellent safety profile in pediatric surgical patients.[7] The Pericapsullar nerve group (PENG) block is a novel motor-sparing regional anesthetic technique where the local anesthetic agent is deposited in the musculofascial plane between the psoas tendon and the pubic ramus. The main target is the genicular branches of the femoral, obturator, and accessory obturator nerve, which innervate the hip capsule.[8]

However, pediatric peripheral RA lags behind adult practice in the type of RA offered and the percentage of cases performed with a regional technique among eligible patients. No prospective randomized trials compare the analgesic efficacy of PENG block with the traditional caudal epidural block in pediatric patients.

This study is carried out to assess ultrasound-guided PENG block versus caudal block for its analgesic efficacy, opioid-sparing effects, and safety in pediatric hip surgery. The primary objective is to evaluate the postoperative pain scores in the first 24 hours after surgery in patients undergoing hip surgery receiving either PENG or caudal epidural block. The secondary objectives include time to first request opioid analgesics, total opioid consumption in 24 hours, adverse effects, and parents’ satisfaction. We hypothesize that the PENG blocks could offer superior perioperative analgesia compared to caudal epidural for hip surgery in children.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
1.00 Year(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • American Society of Anesthesiologists (ASA) physical status class I–II and scheduled for elective unilateral hip surgery due to hip avascular necrosis, dislocation, dysplasia or fracture.

排除标准

  • Children diagnosed with neurological, spinal, or coagulation disorders, infections suspected or confirmed to be related to block sites, histories of allergies to local anesthetics (LAs), bilateral or redo hip surgeries, and parents who refused to participate in the study will be excluded.

结局指标

主要结局

to evaluate the postoperative pain scores in the first 24 hours after surgery in patients undergoing hip surgery receiving either PENG or caudal epidural block.

时间窗: intraoperatively after administration of the block and at 30,60,90,120min,6,12 and 24hours postoperatively.

次要结局

  • time to first request opioid analgesics, total opioid consumption in 24 hours, adverse effects, and parents’ satisfaction.(intraoperatively after administration of the block and at 30,60,90,120min,6,12 and 24hours postoperatively.)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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