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临床试验/CTRI/2025/10/095897
CTRI/2025/10/095897尚未招募不适用

A prospective randomized study to compare Intravenous Ibuprofen versus Intravenous Paracetamol in post operative pain management of vaginal hysterectomy patients under spinal anesthesia.

GMERS Medical College and Hospital Gotri Vadodara1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年11月19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
40
试验地点
1
主要终点
Total opioid consumption in 24 hours with use of two study drugs

研究概览

简要总结

This prospective randomized controlled study is designed to compare the efficacy and safety of intravenous ibuprofen versus intravenous paracetamol in the management of postoperative pain in patients undergoing vaginal hysterectomy under spinal anesthesia.

Eligible patients will be randomized into two groups:

Group I (Ibuprofen group): will receive IV ibuprofen 800 mg every 8 hours.

Group P (Paracetamol group): will receive IV paracetamol 1 g every 8 hours.

•SAB using Inj Bupivacaine heavy (0.5%) 3.6 ml + Inj Butorphanol 0.2 mg , to make total volume of 3.8 ml injected into subarachnoid space using 23 Q Quincke’s spinal needle

•Immediately post operatively, a baseline VAS observed.

•Study drug administered 30 mins after shifting the patient to a recovery room.

• VAS Score assessed at 30 min, 60 min, 90 min, 2 hours and there after every 2 hours following the first dose till 24 hours.

• Rescue analgesia in the form of Inj Tramadol 2 mg/kg is given if VAS score more than 4

•T0 is the time of giving the first dose of study drug and the time from T0 to first rescue analgesia will be considered as the total duration of analgesia.

The primary outcome is to compare the total opioid consumption in 24 hours with the use of two study drugs.

The secondary outcomes such as to compare the duration of analgesia with either of the study drug (from first administration to requirement of rescue analgesia), assess hemodynamic stability of both drugs and to compare the incidence of adverse events

This study aims to evaluate and compare the analgesic efficacy, duration of pain relief, opioid sparing effect of IV ibuprofen (new formulation) and IV paracetamol in the clinical setting.

研究设计

研究类型
Interventional
分配方式
Na
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
35.00 Year(s) 至 65.00 Year(s)(—)
性别
Female

入选标准

  • Female patient posted for Vaginal hysterectomy under Spinal anesthesia consenting for participating in this study Patient aged between 35-65 years All elective surgeries of ASA I and II patients.

排除标准

  • 1.Patient’s refusal 2.History of allergy or hypersensitivity to NSAIDs 3.History of Peptic ulcer or intestinal Inflammatory disease.
  • 4.Contraindications for spinal anaesthesia 5.Coagulation disorders 6.Any systemic organ involvement or any other co morbidity.
  • 7.Duration of Surgery more than 2 hours.

结局指标

主要结局

Total opioid consumption in 24 hours with use of two study drugs

时间窗: Total opioid consumption in 24 hours with use of two study drugs

次要结局

  • To Compare the duration of analgesia with either of the study drug (from first administration to requirement of rescue analgesia)(To assess hemodynamic stability of both drugs)

研究者

发起方
GMERS Medical College and Hospital Gotri Vadodara
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr. Pooja Zala

GMERS Medical college and Hospital, Gotri, Vadodara

研究点 (1)

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