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临床试验/CTRI/2025/05/086270
CTRI/2025/05/086270招募中2/3 期

A Comparative Study of Epidural Nalbuphine versus Tramadol as an adjuvant to Levobupivacaine for post operative Analgesia in lower abdominal surgeries in a tertiary care centre - A double blind randomises control trial

VARUN S1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年5月27日最近更新:

试验速览

阶段
2/3 期
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
VAS Score

研究概览

简要总结

Postoperative pain is a common and distressing experience for patients undergoing surgery. Effective pain management is crucial for patient comfort, early mobilization, and improved recovery outcomes. While regional anesthesia techniques like epidural and spinal anesthesia provide excellent intraoperative analgesia, postoperative pain often necessitates the use of opioid analgesics.

Opioids are effective in managing postoperative pain, but they can have significant side effects such as nausea, vomiting, respiratory depression, and constipation. Therefore, there is a continuous search for safer and more effective analgesics with fewer side effects.

This study aims to compare the efficacy and safety of two commonly used opioid analgesics, nalbuphine and tramadol, as adjuvants to bupivacaine for postoperative analgesia in patients undergoing lower abdominal surgeries.

Nalbuphine, a mixed agonist-antagonist opioid, has demonstrated analgesic efficacy with a lower incidence of respiratory depression compared to full agonists like morphine.

Tramadol, a synthetic opioid with a unique mechanism of action, also provides analgesia with a relatively lower risk of respiratory depression.

By comparing the analgesic efficacy, duration of analgesia, and side effect profiles of nalbuphine and tramadol, this study will provide valuable insights into the optimal choice of opioid adjuvant for postoperative pain management in lower abdominal surgeries.

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 60.00 Year(s)(—)
性别
All

入选标准

  • Age from 18 to 60 years Both male and females.

排除标准

  • Contraindications to regional anaesthesia Known allergy to any of the study drugs Lower segment Caeserean section Associated hepatic or renal dysfunction.

结局指标

主要结局

VAS Score

时间窗: 30 min, 1hr, 2hrs 4hrs, 8hrs,12 hrs,24 hrs, 36 hrs and 48 hrs after surgery

Ramsay sedation score

时间窗: 30 min, 1hr, 2hrs 4hrs, 8hrs,12 hrs,24 hrs, 36 hrs and 48 hrs after surgery

次要结局

  • Onset of analgesia(Duration of analgesia)

研究者

发起方
VARUN S
申办方类型
Other [Self funding]
责任方
Principal Investigator
主要研究者

Varun S

Karpaga Vinayaga Institute of Medical Sciences and Research Centre

研究点 (1)

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