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临床试验/CTRI/2025/04/084897
CTRI/2025/04/084897尚未招募不适用

Comparison of preoperative administration of pregabalin and duloxetine for postoperative pain

Dayanand medical college and hospital Ludhiana Punjab1 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2025年4月27日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
260
试验地点
1
主要终点
To compare the analgesic efficacy of oral Pregabalin and Duloxetine using VAS score

研究概览

简要总结

The pain pattern after laparoscopic cholecystectomy is complex and distinct from postoperative pain after other laparoscopic procedures, suggesting that procedure specific optimal analgesic management plans should be proposed. Duloxetine is a SNRI  which is being used as an adjunct for management of neuropathic pain and attenuation of postoperative pain especially in lower limb surgeries. Pregabalin ,a structural analogue of GABA , reduces opioid consumption and postoperative pain after major surgeries. However, the comparison of these drugs on global postoperative quality of recovery in laparoscopic surgeries has yet to be evaluated. An interventional randomised study will be conducted in 260 adult patients of American Society of Anesthesiologists(ASA) grade I-III aged 18-65 years scheduled for laparoscopic cholecystectomy under general anesthesia who will be randomly and equally divided into two groups I,II. Group I 130 patients will be administered preoperatively 75 mg of capsulePregabalin orally and group II 130 patients 60 mg of capsule Duloxetine orally one hour prior to the surgery. Postoperative analgesic efficacy will be compared in both the two groups by using VAS score at 0 min, 1,2,4,8,12,24 hours along with assessment of sedation using Numeric Sedation Scale at 0,1,2,4,8,12 and 24 hours, time to first rescue analgesia and total amount of rescue analgesia required in first 24 hours.

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-III patients
  • Adult patients (18-65 years)
  • Either gender
  • Patients scheduled for laparoscopic cholecystectomy under general anaesthesia.

排除标准

  • Patient with known allergy to any of the study drug
  • ASA grade IV or more
  • Patients with underlying psychiatric disorders
  • Patients on antiepileptics or MAO inhibitors
  • Patients on chronic pain medications
  • Patients with H/O SIADH • Patients with H/O syncope • Lactating and pregnant females • Patient refusal.

结局指标

主要结局

To compare the analgesic efficacy of oral Pregabalin and Duloxetine using VAS score

时间窗: VAS score at PACU at 0 minutes (on shifting to PACU), 1, 2, 4, 8, 12, 24 hours postoperatively

次要结局

  • 1. To compare the consumption of total rescue analgesic in first 24 hours postoperatively(2. Postoperative sedation using five point NSS scale)

研究者

发起方
Dayanand medical college and hospital Ludhiana Punjab
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Gurpreeti Kaur

Dayanand Medical College and Hospital

研究点 (1)

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