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临床试验/CTRI/2025/02/080148
CTRI/2025/02/080148尚未招募2 期

External oblique intercostal block vs Oblique subcostal transversus abdominis plane block for postoperative pain management in surgeries with modified Makuuchi incision- A Randomised Controlled Study (OBLIQUES

Angshuman Rudrapal1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年2月15日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
24 hours intravenous morphine consumption in mg

研究概览

简要总结

The modified Makuuchi incision involves a vertical midline cut that meets a horizontal incision at the umbilical level involving T6-T10 dermatomes. The horizontal incision takes a reversed L-shape, following the contour of the abdominal skinfold, ending at the midpoint between the lowest rib and the anterior superior iliac spine. This incision is often employed for upper abdominal surgeries like radical cholecystectomy, hepatectomy, Whipple’s procedure and radical nephrectomy. The institutional practice is to give bilateral oblique subcostal TAP block in these surgeries for postoperative analgesia as a part of an enhanced recovery protocol. This blocks the anterior cutaneous branches but spares the lateral cutaneous branches of T6-T10 intercostal nerves and hence does not cover the

horizontal part of the incision. The external oblique intercostal block (EOIB),initially described by Elsharkawy et al, is a novel fascial plane block indicated for upper abdominal

procedures. It blocks the anterior and lateral cutaneous branches of the T6–T10 intercostal nerves and can be performed easily under ultrasound guidance due to the superficial location of the fascial plane between the external oblique and intercostal muscles. To our knowledge, analgesic efficacy of EOIB vs OSTAP in surgeries involving modified Makuuchi

incision has not been investigated yet in a randomised controlled trial. So, this single centre, randomised, double-blind controlled trial has been designed to investigate the analgesic

efficacy of EOIB vs OSTAP in surgeries involving modified Makuuchi incision. 35 patients will be analysed in each group. Eligible patients undergoing elective abdominal surgeries with modified Makuuchi incision or reversed L- shaped incision will be included in our study. Our primary outcome is the 24 hour postoperative morphine consumption, while secondary outcomes include 48-hours and 72-hours intravenous morphine consumption in mg, QOR-15 score at postoperative day 1 and postoperative day 3, Postoperative rescue fentanyl requirements in mcg in the first 48 hours, Numeric Rating Scale (NRS) of static and dynamic pain, Modified Ramsay Sedation Score at various time intervals, complications like postoperative respiratory depression, PONV, pruritus, time to enteric resumption, ambulation and flatus pass, patient satisfaction score, length of hospital stay.

研究设计

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

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Patients undergoing elective abdominal surgeries with modified Makuuchi incision or reversed L- shaped incision.
  • American Society of Anaesthesiology Physical Score (ASA-PS) score of I.

排除标准

  • Patients requiring postoperative mechanical ventilation.
  • Contraindications to spinal anaesthesia Contraindications to study medication Documented obstructive sleep apnea Patients with life threatening arrhythmias Patients with left ventricular ejection fraction less than 40% Coagulopathy Pre Existing neurological illness Significant liver dysfunction (liver enzymes more than 3 times normal) Significant renal dysfunction (creatinine more than 2 times normal) Psychiatric illness Opioid abuse Patients receiving systemic opioids for chronic pain within last 30 days.

结局指标

主要结局

24 hours intravenous morphine consumption in mg

时间窗: 24 hours intravenous morphine consumption in mg

次要结局

  • 1. 48-hours and 72-hours intravenous morphine consumption in mg(2. QOR-15 score at postoperative day 1 and postoperative day 3)

研究者

发起方
Angshuman Rudrapal
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Angshuman Rudrapal

Tata Medical Center

研究点 (1)

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