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临床试验/CTRI/2025/02/081378
CTRI/2025/02/081378尚未招募不适用

Comparison of classical midline approach versus modified paramedian approach in spinal Anaesthesia for lower limb orthopedic surgeries in elderly patients

Dr Gopikrishnan1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年3月28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
80
试验地点
1
主要终点
success rates and lesser number of attempts

研究概览

简要总结

After approval from ethical committee, patients posted for lower limb orthopedic surgeries in geriatric age from the Department of Orthopaedics surgery will be taken for study after obtaining written and informed consent, anaesthetic checkup will be done on those patients who fit into the inclusion criteria will be analyzed thoroughly and taken up for the study.

Randomization will be done by computer generated card of patient and allocated into two equal groups: Group A and Group B

Group A: Patients who are receiving classical midline neuraxial block (n=40)

Group B: Patients who are receiving modified paramedian neuraxial block (n=40)

During the procedure, number of attempts, time taken to perform the spinal anaesthesia will be recorded. After the procedure, standard monitoring of ECG, pulse oximetry and non-invasive blood pressure for 30minutes.

After adequate eye opening and maintenance of airway reflexes patients would be transferred post anesthesia recovery unit. All patients are followed up by postoperatively for 24 hours.

Further patients will be assessed for the efficacy of post operative analgesia using the VAS score and will be monitored for other variables such as complications.

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
65.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Patient posted for elective lower limb orthopedic surgeries under ASA I and II with BMI 18.5-29.9 (normal and overweight category).

排除标准

  • Emergency lower limb orthopedic surgeries.
  • Refusal to participation.
  • Allergic to local anaesthetic and adjuvants.
  • Contraindications to Spinal anaesthesia Local infections.

结局指标

主要结局

success rates and lesser number of attempts

时间窗: 30minutes

次要结局

  • To assess the occurrence of side effects such as headache, nausea, vomiting within 24 hours of operation and Visual analogue scale for low back pain.(24 hours)

研究者

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

Dr Gopikrishnan

shri sathya sai medical college and research institute

研究点 (1)

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