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临床试验/CTRI/2025/08/093761
CTRI/2025/08/093761尚未招募4 期

EFFECT OF ADDITION OF BUPRENORPHINE VS NALBUPHINE TO 0.75 PERCENT HYPERBARIC ROPIVACAINE FOR THE SUBARACHNOID BLOCK IN INFRA-UMBILICAL SURGERIES

Adesh University1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2025年9月20日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
105
试验地点
1
主要终点
To compare the characteristics of sensory and motor blockade as well as the total duration of

研究概览

简要总结

Subarachnoid block , also known as spinal anaesthesia , is a regional anaesthesia technique that involves the injection of a local anaesthetic into the subarachnoid space. This technique provides effective intraoperative anaesthesia and contributes significantly to postoperative pain management , which remains a critical component of enhanced recovery protocols in modern surgical practice. Ropivacaine has emerged as a suitable alternative local anaesthetic for subarachnoid blocks , offering reliable sensory and motor blockade with a favourable safety profile compared to other local anaesthetic.

Buprenorphine , a partial mu receptor agonist and kappa receptor antagonist ,offers unique pharmacological advantages , high potency, long duration of action, less potential for respiratory depression , minimal dependency and abuse potential.

Similarly nalbuphine a synthetic opioid agonist-antagonist acting primarily on kappa-receptors and partially inhibiting mu-receptors ,has gained attention for its ability to provide effective analgesia with potentially fewer side effects than pure mu-agonists.

Recent studies have demonstrated the efficacy of both buprenorphine and nalbuphine as intrathecal adjuvants, but comparative studies directly evaluating their relative benefits in combination with ropivacaine are scarce.

Given the evolving landscape of multi-modal analgesia and the move away from pure mu-agonists like fentanyl because of their side effects ,there is increasing interest in partial agonist drugs like nalbuphine and buprenorphine .

研究设计

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

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • ASA grade I and II patients of all genders Patients posted for elective surgeries below umbilicus.

排除标准

  • Contraindications to spinal anaesthesia (coagulopathy, local infection, severe hypovolemia) History of allergy to study medications Significant cardiovascular, respiratory, renal, or hepatic dysfunction Pregnancy or lactation Patients on chronic analgesic therapy Patients with psychiatric disorders.

结局指标

主要结局

To compare the characteristics of sensory and motor blockade as well as the total duration of

时间窗: T0- 15min | T1- 30 min | T2-45 min | T3-60 min

effective analgesia across all three groups.

时间窗: T0- 15min | T1- 30 min | T2-45 min | T3-60 min

次要结局

  • 1. Hemodynamic parameters (SBP, DBP, MAP, HR, SPO2 & RR) at baseline & at 5, 10,(15, 30, 60, 90, & 120 minutes after spinal anaesthesia.)
  • Sedation score using Ramsay sedation scale.(Time Sedation Score)
  • Incidence of side effects like nausea & vomiting (PONV), pruritus, respiratory(depression, hypotension, bradycardia.)
  • Patient satisfaction score on a 5-point Likert scale (1=very dissatisfied, 5=very satisfied)(using a specially designed questionnaire.)

研究者

发起方
Adesh University
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Roopkamal Kaur Dhami

Adesh Institute Of Medical Sciences And Research

研究点 (1)

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