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临床试验/CTRI/2025/06/088900
CTRI/2025/06/088900尚未招募不适用

A comparative study of Ultrasound guided Median, Paramedian and Modified Paramedian techniques for Spinal Anaesthesia in ELderly patients.

Dr. Dipjyoti Bharadwaj1 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2025年6月27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
135
试验地点
1
主要终点
To Compare the first attempt success rate between median, paramedian and modified paramedian approaches of spinal anaesthesia

研究概览

简要总结

Due to an increasingly ageing population, the number of elderly who need surgical treatment under spinal anaesthesia is increasing(1,2). The mean age for spinal anaesthesia cohort for hip fracture repair demonstrated an increasing trend over time whereas the mean age of the general anaesthesia cohort did not. Studies have shown that the risk of many urinary system diseases( such as benign prosthatic hyperplasia, bladder tumours, urethral strictures) increase drastically with ageing. (3,4) Compared to general anaesthesia spinal anaesthesia has been recognised as providing greater haemodynamic stability, higher patient satisfaction, lower rate of opioid use, higher rate of opioid free recovery and lower maximum post anaesthesia care unit (pacu) pain scores.(4) Due to degeneration of the lumbar spine (bone hyperplasia, ligament calcification, intervertebral space stenosis, spinous process hyperplasia, etc) spinal anaesthesia in elderly patients might be difficult.(8-9) Multiple needle attempt may lead to a higher incidence of complications(post dural puncture headache, paraesthesia, hematoma and infection) increased patient discomfort and dissatisfaction.

There are two traditional techniques for spinal anaesthesia ( midline technique and paramedian technique) each of which has some advantages and disadvantages in terms of operation and application. Lots of anaesthesiologists proceed through paramedian approach because this approach bypasses most of the bony structures that may impede the advancement of the needle in midline approach. However, paramedian approach requires a sharpened three-dimensional insight as compared to the midline approach. We would encounter inferior articular processes and pedicle more close to needle pathway and less interlaminar foramen diameter in three dimensional structure especially in obese patients.(8)  Therefore, a new approach , the modified paramedian approach using the ultrasound guidance may improve success rate and decrease practice attempts and patient complications.

The purpose of the study is to explore the feasibility of ultrasound assisted modified paramedian technique for spinal anaesthesia in elderly when compared to midline and paramedian approach.

The Null Hypothesis of the study is that there will be no differences in first attempt success rates using ultrasound guidance for spinal anesthesia in elderly for midline , paramedian and modified paramedian approaches.

AIM:   The aim is to combine the advantages of two traditional methods (midline and paramedian), Improve the success rate of spinal anaesthesia, Reduce the time taken to puncture and the number of attempts and to facilitate the process of anaesthesia in elderly patients.

PRIMARY OBJECTIVE:  To determine the first attempt success rate.

SECONDARY OBJECTIVE:

To determine number of attempts

Number of needle redirections

Time taken to perform spinal anaesthesia

Time taken to ultrasound assisted location

The incidences of headache, backpain, nausea and vomiting within 24hrs after the operation.

REFERENCES:

Park SK, Yoo S, Kim WH, Lim YJ, Bahk JH, Kim JT. Ultrasound-assisted vs. landmark-guided paramedian spinal anaesthesia in the elderly: A randomised controlled trial. Eur J Anaesthesiol. 2019 ;36(10):763-771.

Maxwell BG, Spitz W, Porter J. Association of Increasing use of spinal anesthesia in hip fracture repair with treating an aging patient population. JAMA Surg. 2020;155(2):167–8.

Cao JL, Li JP, Yang X, et al. Transcriptomics analysis for the identification of potential age-related genes and cells associated with three major urogenital cancers. Sci Rep. 2021;11(1):641.

Westhofen T, Stief CG, Magistro G. Spinal versus general anesthesia for holmium laser Enucleation of the prostate of high-risk patients – a propensity-score-matched-analysis REPLY. Urology. 2022;159:189–90.

Zeng, W., Shi, Y., Zheng, Q. et al. Ultrasound-assisted modified paramedian technique for spinal anesthesia in elderly. BMC Anesthesiol. 2022; 22, 242.

Tien M, Kou A, Leppert JT, et al. Spinal anesthesia increases the rate of opioid-free recovery after transurethral urologic surgery. J Clin Anesth. 2020;60:109–10.

Bosio A, Alessandria E, Vitiello F, et al. Flexible Ureterorenoscopy under spinal anesthesia: focus on technique, results, complications, and Patients’ satisfaction from a large series. Urol Int. 2021;8:1–6.

Jinyoung B, Sun-Kyung, et al. Infuence of age, laterality, patient position, and spinal level on the interlamina space for spinal puncture. Reg Anesth Pain Med. 2019:rapm-2019-100980. https://doi.org/10.1136/rapm-2019-100980.

Aylott CE, Puna R, Robertson PA, et al. Spinous process morphology: the efect of ageing through adulthood on spinous process size and relationship to sagittal alignment. Eur Spine J. 2012;21(5):1007–12.

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
60.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • ASA Physical status- 1-3
  • Patient posted for elective surgery under Spinal Anaesthesia.

排除标准

  • Patient refusal
  • Local infections
  • Allergy to local anaesthetics
  • History of spinal surgeries.
  • Communication Difficulties.
  • Problems related to ultrasound scanning.

结局指标

主要结局

To Compare the first attempt success rate between median, paramedian and modified paramedian approaches of spinal anaesthesia

时间窗: At the time of Anaesthesia

次要结局

  • To determine number of attempts(Number of needle redirections)

研究者

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

Dr Dipjyoti Bharadwaj

Gauhati Medical College and Hospital

研究点 (1)

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