| CTRI Number |
CTRI/2026/02/104854 [Registered on: 26/02/2026] Trial Registered Prospectively |
| Last Modified On: |
25/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Diagnostic Accuracy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Accuracy of Epidural Pressure Waveform Analysis for Determining the Correct Placement of Epidural Catheter in Elderly Patients-An Observational Analytical Study |
|
Scientific Title of Study
|
Accuracy of Epidural Pressure Waveform Analysis for Determining the Correct Placement of Epidural Catheter in Elderly Patients-An Observational Analytical Study |
| 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 Afnan Rimzy P |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Anaesthesiology and Critical Care,2nd floor institute
block,Jawaharlal Institute of Postgraduate Medical Education and Research,JIPMER campus
Pondicherry
PONDICHERRY
605006
India
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9567780816 |
| Fax |
|
| Email |
afnanrimzy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sakthirajan P |
| Designation |
Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Anaesthesiology and Critical Care,2nd floor institute
block,Jawaharlal Institute of Postgraduate Medical Education and Research,JIPMER campus
Pondicherry
PONDICHERRY
605006
India
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8903468132 |
| Fax |
|
| Email |
sakthiab8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Afnan Rimzy P |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Anaesthesiology and Critical Care,2nd floor institute
block,Jawaharlal Institute of Postgraduate Medical Education and Research,JIPMER campus
Pondicherry
PONDICHERRY
605006
India
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9567780816 |
| Fax |
|
| Email |
afnanrimzy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Postgraduate Medical Education and Research,JIPMER campus road,Gorimedu,Dhanvantri nagar,Pondicherry,India-605006 |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Jawaharlal Institute of Postgraduate Medical Education and Research,JIPMER campus road,Gorimedu,Dhanvantri nagar,Pondicherry,India-605006 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Afnan Rimzy P |
Jawaharlal Institute of Postgraduate Medical Education and Research |
Department of Anaesthesiology and critical care office, Second floor institute block,JIPMER
campus road, Gorimedu, Dhanvantri nagar, Pondicherry, India 605006
Pondicherry
PONDICHERRY |
9567780816
afnanrimzy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee For Observational Studies JIPMER, Puducherry |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dermatomal Testing of Cold Sensation Using Sponge Soaked with Isopropyl Alcohol |
After the epidural catheter is placed and a local anaesthetic test dose is administered, the level of sensory block is checked.The test involves checking for a segmental sensory block using a cold sponge soaked with isopropyl alcohol, which is applied bilaterally in the congruent dermatomes, starting five minutes after the test dose is given.The appearance of a sensory block covering at least one dermatome is considered a positive test, indicating the correct placement of the epidural catheter. If no sensory block is present at five minutes, it is rechecked at 10 and 15 minutes, with the absence of segmental loss of cold sensation is considered as negative test. |
| Intervention |
Epidural Pressure Waveform Analysis |
After the epidural catheter is placed and test dose injected, a sterile pressure transducer system, flushed with 0.9% saline, is directly connected to the epidural catheter. An anaesthesiologist, who is blinded to the results of the cold sponge test, performs this analysis.The anaesthesiologist injects an initial 5 ml of 0.9% saline through the catheter and observes the multiparameter monitor.The presence of a positive pressure waveform that is synchronous with the heart rate of the patient is documented, indicating correct catheter placement.If the waveform does not appear,the catheter is flushed again with 5 ml saline and checked for waveform at 10 minutes along with correction of blood pressure, mean arterial pressure to more than 65 mmHg.If still absent,waveform is checked again at 15 minutes after another 5 ml saline administration.Absence of waveform indicates negative test. |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of age 60 years and above undergoing surgeries anticipated to have epidural anaesthesia or analgesia through epidural catheter.
2.American Society of Anaesthesiologists (ASA) physical status I -III.
|
|
| ExclusionCriteria |
| Details |
1.Patients with hemodynamic instability
2.Coagulation disorders
3.Local site infection
4.Hypersensitivity to local anaesthetics
5.Plan for real time, USG guided epidural placement
6.Contraindication to adrenaline containing epidural test dose
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find the sensitivity and specificity of epidural waveform analysis to determine the correct placement of epidural catheter. |
Upto 15 mins from epidural placement |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To find the positive predictive value and negative predictive value of epidural waveform analysis
2.To find the accuracy with respect to thoracic and lumbar epidural placement
3.To find the amount of saline required to obtain the epidural pressure waveforms
4.To find the number of epidural revision rates.
5.To find the association between mean arterial pressure and presence or absence of epidural waveform
6.To find the association between plethysmographic variability index and the presence or absence of epidural waveform
|
Upto 15 minutes from epidural placement |
|
|
Target Sample Size
|
Total Sample Size="193"
Sample Size from India="193"
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)
|
31/03/2026 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This observational analytical study evaluates the diagnostic accuracy of Epidural Pressure Waveform Analysis using an arterial pressure transducer for confirming the correct placement of an epidural catheter in elderly patients of age 60 years and above undergoing surgery. The study is designed to compare the Epidural Pressure Waveform Analysis method against the dermatomal testing of cold sensation. A total of 193 elderly patients will be enrolled in the study. The design employs blinding, where one anesthesiologist performs the cold sponge test and a second anesthesiologist, blinded to the results of the cold test, performs the waveform analysis. The primary outcome is to determine the sensitivity and specificity of epidural waveform analysis in identifying correct catheter placement. Secondary outcomes include finding the positive predictive value and negative predictive value, evaluating the accuracy with respect to thoracic and lumbar epidural placement, determining the amount of saline required to obtain the epidural pressure waveforms, measuring the number of epidural revision rates, and finding the association between mean arterial pressure, plethysmographic variability index, and the presence or absence of the epidural waveform. The study aims to determine if the cost-effective and objective Epidural Pressure Waveform Analysis method is a reliable diagnostic tool for confirming epidural catheter placement in the elderly population, where existing literature on this method is lacking for this age group.
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