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临床试验/CTRI/2024/10/075846
CTRI/2024/10/075846尚未招募4 期

Comparison of effect of two different doses of oral Pregabalin in reducing postoperative analgesia in patients receiving neuraxial anaesthesia for surgical procedures - A randomized controlled trial

SRM1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年11月5日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
SRM
入组人数
90
试验地点
1
主要终点
To compare the duration of postoperative analgesia between the 3 groups using Visual Analogue Scale

研究概览

简要总结

A total of 90 patients belonging to the age group of 18-65 years, assessed under ASA I and ASA II, scheduled for elective surgeries under spinal anesthesia blockade will be prospectively studied. In this double-blinded randomised controlled trial, a total of 90 participants will be allocated into three groups- Group A(Conventional Spinal Anaesthesia), Group B(150mg T.Pregabalin preoperatively) and Group C(300mg T.Pregabalin preoperatively). Patients will receive either their allocated drug or a placebo in the conventional group 1 hour before surgery. Their level of sedation will be assessed after the hour using Ramsay Sedation Scale before shifting the patients to the OT. All patients will receive 0.5% hyperbaric bupivacaine 0.3mg/kg intrathecally at L3-L4 space with 25G Quincke needle under aseptic precautions. All patients will be assessed for their pain using the Visual Analogue Scale postoperatively for 24 hours. Data collection will be done by observation and measurement of various parameters.

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

  • Patients scheduled to undergo elective surgeries under neuraxial anaesthesia
  • ASA I and ASA II patients
  • Patients aged 18-65 years
  • Patients with BMI less than 24.9.

排除标准

  • Patient refusal
  • Spinal deformities
  • Raised ICP
  • Infection at site of procedure
  • Coagulation disorders.

结局指标

主要结局

To compare the duration of postoperative analgesia between the 3 groups using Visual Analogue Scale

时间窗: 1hr, 3hr, 6hr, 12hr, 24hr

次要结局

  • To assess level of sedation using Ramsay Sedation Scale both preoperatively and postoperatively(1hr, 1.5hr, 2hr, 2.5hr, 3hr, 3.5hr, 4hr, 4.5hr, 5hr, 5.5hr, 6hr)
  • The number of rescue analgesic doses required in the first 24 hours(1hr, 6hr, 12hr, 24hr)

研究者

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

Dr Nanditha Padikkasu

SRM Medical College Hospital and Research Centre

研究点 (1)

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