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临床试验/CTRI/2025/11/097920
CTRI/2025/11/097920尚未招募Phase 3 4

COMPARATIVE STUDY OF DURATION OF POST OPERATIVE ANALGESIA WITH INTRATHECAL VERSUS SUBCUTANEOUS DEXMEDETOMIDINE AS AN ADJUVANT TO 0.5% HYPERBARIC BUPIVACAINE IN LOWER LIMB SURGERIES -A RANDOMIZED CONTROLLED TRIAL

Jubilee Mission Medical College and Research Institute1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年12月4日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
duration of postoperative analgesia, measured by

研究概览

简要总结

This randomized controlled trial titled “Comparative study of duration of postoperative analgesia with intrathecal versus subcutaneous dexmedetomidine as an adjuvant to 0.5% hyperbaric bupivacaine in lower limb surgeries” aims to evaluate the effectiveness of two routes of dexmedetomidine administration in prolonging postoperative analgesia. The study will be conducted in the Department of Anaesthesiology, Jubilee Mission Medical College and Research Institute, Thrissur, over a period of 18 months. Thirty adult patients aged 18–60 years, belonging to ASA physical status I or II and scheduled for elective lower limb surgeries under spinal anesthesia, will be enrolled and randomly allocated into two groups of fifteen each using computer-generated randomization. Group A will receive 3 mL of 0.5% hyperbaric bupivacaine with 5 µg intrathecal dexmedetomidine and subcutaneous normal saline, while Group B will receive 3 mL of 0.5% hyperbaric bupivacaine intrathecally and 0.5 µg/kg dexmedetomidine subcutaneously. Both the anesthesiologist and the patient will be blinded to group allocation. The primary outcome of the study will be the duration of postoperative analgesia, measured as the time to first request for rescue analgesia. Secondary outcomes include hemodynamic stability, onset and duration of sensory and motor block, incidence of adverse effects such as bradycardia, hypotension, and nausea, total analgesic requirement within 24 hours, and patient satisfaction scores. Data will be analyzed using SPSS version 24, with results expressed as mean ± standard deviation for continuous variables and percentages for categorical variables. Statistical tests such as the independent t-test and chi-square test will be used, and a p-value less than 0.05 will be considered significant. This study seeks to determine whether subcutaneous dexmedetomidine provides analgesic efficacy comparable to intrathecal administration, potentially offering a simpler and safer alternative route for postoperative pain management following lower limb surgeries.

研究设计

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

  • Patients aged 18 to 60 years • American Society of Anaesthesiology physical status 1 to 2 • Scheduled for elective lower limb surgeries under spinal anaesthesia • Duration of surgery should be less than 150 minutes.

排除标准

  • Known hypersensitive to study drugs • Contraindications to spinal anaesthesia • Patients with baseline heart rate <60bpm • Patient complaints of pain during procedure • Failed spinal anesthesia • Addition of any other analgesic medication during procedure.

结局指标

主要结局

duration of postoperative analgesia, measured by

时间窗: duration of postoperative analgesia, measured by | time to first request for analgesics.

time to first request for analgesics.

时间窗: duration of postoperative analgesia, measured by | time to first request for analgesics.

次要结局

  • Hemodynamic parameters monitored intraoperatively(From initiation of spinal anesthesia until the end of surgery (measured at baseline, every 3 minutes for the first 30 minutes, and then every 10 minutes until completion of surgery))
  • Duration of sensory and motor block, assessed by standardised scales and time to(regression)
  • To evaluate overall patients satisfaction post operative.(At 24 hours after surgery)

研究者

发起方
Jubilee Mission Medical College and Research Institute
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr ARATHY C A

Jubilee Mission Medical College and Research Institute

研究点 (1)

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