| CTRI Number |
CTRI/2025/06/088900 [Registered on: 16/06/2025] Trial Registered Prospectively |
| Last Modified On: |
15/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
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Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
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Public Title of Study
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Comparing three Ultrasound Methods to Make Spinal Anaesthesia easier and Safer for Older adults. |
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Scientific Title of Study
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A comparative study of Ultrasound guided Median, Paramedian and Modified Paramedian techniques for Spinal Anaesthesia in ELderly patients. |
| Trial Acronym |
NIL |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dipjyoti Bharadwaj |
| Designation |
postgraduate resident |
| Affiliation |
Gauhati Medical College and Hospital |
| Address |
Dept. of Anaesthesia and critical Care, Gauhati Medical College And Hospital, Assam.
Kamrup ASSAM 781032 India |
| Phone |
8403006162 |
| Fax |
|
| Email |
dipjyotibharadwaj@gmail.com |
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Details of Contact Person Scientific Query
|
| Name |
Dr Faiza Ahmed Talukdar |
| Designation |
Professor and Head of the Department |
| Affiliation |
Gauhati Medical College and Hospital |
| Address |
Department of Anaesthesiology and critical care, Gauhati Medical College and Hoapital, Guwahati, Assam.
Kamrup ASSAM 781032 India |
| Phone |
9864031429 |
| Fax |
|
| Email |
faizaahmedtalukdar@gmail.com |
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Details of Contact Person Public Query
|
| Name |
Dr Dipjyoti Bharadwaj |
| Designation |
postgraduate resident |
| Affiliation |
Gauhati Medical College and Hospital |
| Address |
Dept. of Anaesthesia and critical Care, Gauhati Medical College And Hospital, Assam.
Kamrup ASSAM 781032 India |
| Phone |
8403006162 |
| Fax |
|
| Email |
dipjyotibharadwaj@gmail.com |
|
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Source of Monetary or Material Support
|
| Gauhati Medical College and Hospital, Kamrup (M), 781032, Assam |
|
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Primary Sponsor
|
| Name |
Dr. Dipjyoti Bharadwaj |
| Address |
Department of Anaesthesiology and critical care, Gauhati Medical College and Hospital, Guwahati, Kamrup metro |
| Type of Sponsor |
Other [self] |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
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India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Dipjyoti Bharadwaj |
Gauhati Medical College and Hospital |
Dept. of Anaesthesia and critical Care, Gauhati Medical College And Hospital, Assam. Kamrup ASSAM |
08403006162
dipjyotibharadwaj@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutionl ethics Committee, Gauhati Medical College and Hospital |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
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Intervention / Comparator Agent
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Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA Physical status- 1-3
2. Patient posted for elective surgery under Spinal
Anaesthesia |
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Local infections
3. Allergy to local anaesthetics
4. History of spinal surgeries.
5. Communication Difficulties.
6. Problems related to ultrasound scanning.
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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On-site computer system |
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Blinding/Masking
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Participant and Investigator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| To Compare the first attempt success rate between median, paramedian and modified paramedian approaches of spinal anaesthesia |
At the time of Anaesthesia |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
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 24 hrs after the operation
|
At the time of anaesthesia and within 24 hours of surgery |
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Target Sample Size
|
Total Sample Size="135" Sample Size from India="135"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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N/A |
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Date of First Enrollment (India)
|
27/06/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
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Recruitment Status of Trial (Global)
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Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
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.
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