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临床试验/CTRI/2024/05/066857
CTRI/2024/05/066857尚未招募2/3 期

Evaluation of pre-emptive use of pregabalin for attenuation of post operative pain after laparoscopic abdominal surgeries.

Dr Shrish Satish Shetty1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年5月13日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
To compare the time of requirement for the first dose of rescue analgesic.

研究概览

简要总结

Preemptive analgesia is an antinociceptive treatment that prevents establishment of altered processing of afferent input, which amplifies postoperative pain. Various pharmacological agents and techniques like local infiltration, epidural analgesia, nonsteroidal anti-inflammatory drugs, opioids, Gabapentin, pregabalin, alpha**-**2 agonist, cox-2 inhibitors are used to produce analgesia. Gabapentinoids are anti-convulsants with membrane stabilizing and anti-nociceptive effects. These drugs bind to the presynaptic a2–d subunit voltage-dependent calcium channel. The anti-nociceptive effect is believed to be related to the reduction of the Ca2+ influx at presynaptic terminals in hyperexcited neurons, which may lead to the reduction of the release of several excitatory neurotransmitters, including glutamate, norepinephrine, substance P, and calcitonin gene-related peptide. Thus, gabapentinoids appear to reduce the hyperexcitability of dorsal horn neurons that is induced by tissue damage.  Evidence supporting the postoperative analgesic efficacy of pregabalin is limited to randomized controlled trials in patients undergoing dental surgery, spinal fusion surgery, laparoscopic hysterectomy and day-case gynaecological laparoscopic surgery. Few of these trials has investigated the role of preoperative single-dose administration of pregabalin in attenuating postoperative pain after laparoscopic abdominal surgeries. The present study was therefore designed to evaluate the role of preoperative single dose of pregabalin for attenuating postoperative pain and analgesic consumption in patients undergoing laparoscopic abdominal surgeries.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1.Planned surgeries of either sex 2.Patients aged 18 to 60 years 3.ASA Grade I,II, 4.Undergoing elective laparoscopic surgeries under general anaesthesia.

排除标准

  • 1.Patient refusal.
  • 2.ASA 3 and
  • 3.Patients with other lung and cardiac pathologies.
  • 4.Patients with hypertension, uncontrolled diabetes mellitus, systemic infection,,history of malignancy, history of alcohol or drug abuse.
  • 5.Patient with a history of allergy to pregabalin.

结局指标

主要结局

To compare the time of requirement for the first dose of rescue analgesic.

时间窗: Pain profile is measured in terms of VAS score postoperatively, at 1st, 2nd, 4th, 6th,12th,24th hours

次要结局

  • To compare(1)The amount of rescue analgesic needed postoperatively in first 24 hrs)

研究者

发起方
Dr Shrish Satish Shetty
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Shrish Satish Shetty

B.J.Medical College and Civil Hospital Ahmedabad

研究点 (1)

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