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临床试验/CTRI/2024/08/072494
CTRI/2024/08/072494招募中不适用

Comparison of Quadratus Lumborum Block using Bupivacaine with Dexmedetomidine versus Intrathecal Morphine for Postoperative Analgesia in Laparoscopic Nephrectomies-A randomized study

All India Institute of Medical Sciences Sijua Patrapada Bhubaneswar, Odisha India1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年8月27日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
90
试验地点
1
主要终点
To compare postoperative rescue analgesia as Oral morphine milligram equivalent ( OMME) over 24 hours.

研究概览

简要总结

Laparoscopic Nephrectomies are complex surgical procedures that often result in significant postoperative pain. Effective pain management is crucial for patient recovery and satisfaction. Intrathecal Morphine (ITM) and various regional blocks like Quadratus Lumborum Block (QLB), Erector Spinae Plane Block (ESPB), and Transverse Abdominis Plane (TAP) Block have been used as a part of multimodal analgesia. [1] Intrathecal Morphine (ITM) provide better analgesia for around 24 hours at a significantly lower dose in comparison to intravenous opioids [2]. However, it does have an increased risk for side effects like pruritus, nausea, vomiting, and respiratory depression.  There is paucity of clinical studies exploring the comparative efficacy of Intrathecal Morphine versus Quadratus Lumborum block using Bupivacaine with Dexmedetomidine in laparoscopic nephrectomies, so we have planned this study to compare these two modalities.

References:

1. Srinivasan S, Subramaniam R, Chhabra A, Baidya D, Arora M, Maitra S, et al. Comparison of transversus abdominis plane block and intrathecal morphine for laparoscopic donor  nephrectomy: Randomized controlled trial. Indian J Anaesth. 2020 Jun 1;64(6):507–12. â€‹

2. Koning M V., Klimek M, Rijs K, Stolker RJ, Heesen MA. Intrathecal hydrophilic opioids for abdominal surgery: a meta-analysis, meta-regression, and trial sequential analysis. Vol. 125, British Journal of Anaesthesia. Elsevier Ltd; 2020. p. 358–72.

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 75.00 Year(s)(—)
性别
All

入选标准

  • ASA I/II, 18-75 years male &female patients planned for laparoscopic nephrectomy surgery.

排除标准

  • Patients with known allergy to the drugs used Patients with contraindications for QLB, ITM Patient refusal for consent BMI more than 35.

结局指标

主要结局

To compare postoperative rescue analgesia as Oral morphine milligram equivalent ( OMME) over 24 hours.

时间窗: First 24 hours postoperatively.

次要结局

  • Numeric Rating Scale (NRS) scores at 2,4,8,12,18, & 24hrs(b) Total dose of Intraoperative Opioid used)

研究者

发起方
All India Institute of Medical Sciences Sijua Patrapada Bhubaneswar, Odisha India
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Neha Singh

All India Institute of Medical Sciences, Bhubaneswar

研究点 (1)

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