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临床试验/CTRI/2025/09/095440
CTRI/2025/09/095440尚未招募不适用

Comparison Between Intrathecal 0.5 Percent Isobaric Bupivacaine Hydrochloride Versus 0.5 Percent Hyperbaric Bupivacaine Hydrochloride With Fentanyl As An Adjuvant In Both For Proximal Femur Nailing Surgery A Prospective Randomized Double Blind Controlled Study

Pacific Medical College Hospital1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年10月30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
70
试验地点
1
主要终点
We will compare the efficacy of both hyperbaric and isobaric preparations of bupivacaine and if possible to replace hyperbaric bupivacaine with fentanyl with isobaric bupivacaine with fentanyl specially in elderly patients due to its superior hemodynamic stability postoperative analgesia and recovery

研究概览

简要总结

The primary aim of this study is to compare the efficacy of intrathecal  hyperbaric bupivacaine hydrochloride 2.5 ml with fentanyl 25mcg versus intrathecal isobaric bupivacaine hydrochloride 2.5 ml with fentanyl 25mcg for proximal femur nailing surgery

A  double blind randomized controlled clinical study will be conducted on 70 patients admitted at Pacific Medical college  Udaipur, over the period of two years. After obtaining the approval from the ethical committee of the institution, this study will be conducted. Informed written consent would be taken from patient and his/her relatives. Patients will be randomly divided into two groups using the closed envelope method. The study will include all patients aged between 50 and 70 years of either sex who belong to the American Society of Anesthesiologists ASA grade I or II are scheduled for proximal femoral nailing surgeries and require elective surgery only Group HB  – Total volume 3ml  Hyperbaric Bupivacaine  2.5ml  plus 0.5ml Fentanyl

Group IB  – Total volume 3ml Isobaric Bupivacaine 2.5ml  plus 0.5ml Fentanyl

To minimize bias in the level of block achieved with isobaric or hyperbaric bupivacaine a uniform total volume of 3 ml of the drug was administered slowly via the intrathecal route in both study groups.

On arrival in Operation Theatre, baseline blood pressure SBP DBP  MAP  heart rate  respiratory rate  and oxygen saturation  were checked before conducting the procedure The drug solution was prepared by another clinician who was not a part of the study Patient’s HR  RR  BP  and SpO2 were monitored continuously during the procedure

Spinal anesthesia would be done under all aseptic conditions with the necessary precautions, in L3-L4 or L4-L5 interspace in sitting position with 25G  Quincke needle via midline approach Patient will be immediately turned to supine and neutral position without any head-high or head-low so as to avoid bias. Blood pressure SBP DBP MAP heart rate  respiratory rate and oxygen saturation would be monitored at every 5 minutes for the first 30 minutes then every 30 minutes till the end of surgery

Sensory blockade was assessed by pin prick test  by using 22G hypodermic needle and Motor blockade was assessed by Modified Bromage scale

Postoperatively VAS score is measured at every 30 minutes until rescue analgesia is given Patient would be monitored for complications like hypotension nausea vomiting headache shivering urinary retention and bradycardia for 24 hours

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

入选标准

  • All patients of age group between 50 and 70 years of either sex Patient belonging to American Society of Anesthesiologists ASA grade I and II Patients posted for Proximal Femoral Nailing surgery Patients who required elective surgery only.

排除标准

  • Patient refusal for the procedure and technical difficulties Age less than 50 and more than 70 years ASA Grade More Than III Patients with known hypersensitivity to Bupivacaine Fentanyl Mental retardation congenital anomaly patients Those with bleeding disorders and local sepsis.

结局指标

主要结局

We will compare the efficacy of both hyperbaric and isobaric preparations of bupivacaine and if possible to replace hyperbaric bupivacaine with fentanyl with isobaric bupivacaine with fentanyl specially in elderly patients due to its superior hemodynamic stability postoperative analgesia and recovery

时间窗: Onset of sensory and motor block | Duration of sensory and motor block Hemodynamic changes at 0,5,10,15,20,25,30,60,90 Minutes

次要结局

  • Efficacy of postoperative analgesia(Side effects (Bradycardia, Respiratory Depression, hypotension, nausea & vomiting, shivering))

研究者

发起方
Pacific Medical College Hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Monish Kumar

Pacific Medical College Hospital

研究点 (1)

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