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临床试验/CTRI/2026/02/103040
CTRI/2026/02/103040尚未招募2/3 期

Comparing Efficacy Of Post Operative Analgesia Between Hyperbaric Levobupivacaine 0.5 Percentage And Hyperbaric Ropivacaine 0.75 Percentage Intrathecally In All Infra Umbilical Surgeries

Vinayaka Missions Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2026年2月18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
62
试验地点
1

研究概览

简要总结

Spinal anaesthesia is widely used for lower abdominal and lower limb surgeries as it provides effective pain relief, ease of administration, and early recovery with minimal side effects. Various local anaesthetic drugs are used for spinal anaesthesia, and their effects on postoperative pain relief and recovery differ.

Levobupivacaine is a long-acting local anaesthetic with lower cardiac and neurological toxicity, while ropivacaine is a shorter-acting drug that allows faster recovery of motor function. This study aims to compare the effectiveness of intrathecal hyperbaric levobupivacaine and hyperbaric ropivacaine in providing postoperative analgesia in infra-umbilical surgeries.

This prospective, single-blinded, randomized controlled study will be conducted at Vinayaka Mission’s Medical College and Hospital, Karaikal. Sixty-two patients aged 18 to 60 years, belonging to ASA physical status I or II, scheduled for elective lower abdominal or lower limb surgeries lasting less than two hours will be included.

Participants will be randomly allocated into two groups. Group A will receive intrathecal hyperbaric levobupivacaine 0.5%, and Group B will receive intrathecal hyperbaric ropivacaine 0.75%. Postoperative pain will be assessed using the Visual Analogue Scale during the first 12 hours. Recovery of sensory and motor block, need for rescue analgesics, haemodynamic changes, and adverse events will be recorded and compared.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant 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

  • ASA Class 1 and
  • Body Mass Index less than 35 kg per metre square.
  • Surgery of less than 2 hours duration.

排除标准

  • ASA Class 3 and
  • Patients with Severe Spinal Deformity.
  • Patients with BMI more than 35 Kg per metre square.
  • Patients Allergic to Amide drugs.

研究者

发起方
Vinayaka Missions Medical College and Hospital
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr K Cheran

Vinayaka Missions Medical College and Hospital

研究点 (1)

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