跳至主要内容
临床试验/CTRI/2024/11/076103
CTRI/2024/11/076103尚未招募不适用

Comparison of efficacy of Nalbuphine-Levobupivacaine combination with Levobupivacaine alone in ultrasound guided Transversus Abdominis Plane block in open inguinal hernia repair surgeries : A randomised control trial

Himanshi Singh1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年11月4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
60
试验地点
1
主要终点
To assess the time of first rescue analgesic (duration of analgesia)

研究概览

简要总结

Pain after open Hernia Repair surgeries can be moderate to severe and may be associated with prolonged hospital stay, increase in sympathetic activity leading to increase in heart rate, blood pressure, respiratory rate and even delirium. Transversus Abdominis Plane (TAP) Block is a recent modality used for postoperative analgesia with minimal side effects in Inguinal Hernia Repair surgeries. A local anaesthetic solution is deposited between the plane of Internal Oblique (IO) and Transversus Abdominis (TA) muscles. The  efficacy of Nalbuphine has been explored as an adjuvant to other drugs in central neuraxial blocks by epidural, caudal and intrathecal routes. But there is limited data of use of Nalbuphine in combination with Levobupivacaine in TAP block. So this study is planned to evaluate the analgesic efficacy of Nalbuphine with Levobupivacaine and Levobupivacaine alone in TAP block in hernia surgeries. The aim of the present study is to compare the analgesic efficacy of Nalbuphine with Levobupivacaine versus Levobupivacaine alone in  TAP block in Inguinal Repair Hernia surgeries. The objective is to assess the time of first rescue analgesic (duration of analgesia), to observe the visual analogue score (VAS)  (resting and ambulatory) for 24 hours, total number of analgesics required in 24 hours, to assess the haemodynamic parameters postoperatively and to observe the side effects.

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
20.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Informed consent, all patients undergoing unilateral open inguinal hernioplasty, ASA class 1 and 2.

排除标准

  • ASA grade III and IV, Allergy to the study drug, Communication difficulties being unable to comprehend visual analogue scale, Bleeding diathesis, Patients with deranged liver and kidney functions, BMI less than 18 and more than 35, Surgery duration of more than 2 hours.

结局指标

主要结局

To assess the time of first rescue analgesic (duration of analgesia)

时间窗: 0 mintues, 30 min, 60 min, 90 min, 120 min, 4 hours, 8 hours, 12 hours, 16 hours, 20 hours, 24 hours

次要结局

  • To observe the visual analogue score (resting and ambulatory) for 24 hours, total number of analgesics required in 24 hours, to assess the haemodynamic parameters postoperatively, to observe the side effects(24 hours)

研究者

发起方
Himanshi Singh
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Himanshi Singh

Ananta institute of medical sciences and research centre, Nathdwara, Rajsamand

研究点 (1)

Loading locations...

相似试验