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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 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing three Ultrasound Methods to Make Spinal Anaesthesia easier and Safer for Older adults.  
Scientific Title of Study   A comparative study of Ultrasound guided Median, Paramedian and Modified Paramedian techniques for Spinal Anaesthesia in ELderly patients.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
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  
 
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  
 
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  
 
Source of Monetary or Material Support  
Gauhati Medical College and Hospital, Kamrup (M), 781032, Assam 
 
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] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
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 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutionl ethics Committee, Gauhati Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 4||Measurement and Monitoring,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
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 
 
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 
 
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" 
Phase of Trial   N/A 
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 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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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