| CTRI Number |
CTRI/2025/05/087241 [Registered on: 21/05/2025] Trial Registered Prospectively |
| Last Modified On: |
21/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of pain during venous cannulation between short and long axes ultrasound probe orientation |
|
Scientific Title of Study
|
A randomized comparative study to evaluate the effect of short axis versus long axis orientation on pain of cannulation during ultrasound guided peripheral venous tapping in S.M.S. Medical College,Jaipur |
| 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 Samridhi Nanda |
| Designation |
Professor |
| Affiliation |
S.M.S Medical College and Hospital,Jaipur |
| Address |
HOD chamber, Department of Anaesthesia,OT complex,1st floor, Dhanwantri OPD building,S.M.S Medical College and Hospital,Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
0141251680 |
| Fax |
|
| Email |
samridhinanda@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Samridhi Nanda |
| Designation |
Professor |
| Affiliation |
S.M.S Medical College and Hospital,Jaipur |
| Address |
HOD chamber, Department of Anaesthesia,OT complex,1st floor, Dhanwantri OPD building,S.M.S Medical College and Hospital,Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
0141251680 |
| Fax |
|
| Email |
samridhinanda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pragya Jha |
| Designation |
Resident doctor |
| Affiliation |
S.M.S Medical College and Hospital,Jaipur |
| Address |
HOD chamber, Department of Anaesthesia,OT complex,1st floor, Dhanwantri OPD building,S.M.S Medical College and Hospital,Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
7093585435 |
| Fax |
|
| Email |
pragyajha1528@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesia Sawai Man SinghMedical college and attached hospitals,Jaipur,Rajasthan,India |
|
|
Primary Sponsor
|
| Name |
Department of anaesthesia Sawai Man Singh Medical college and attached hospital Jaipur |
| Address |
Department of anaesthesia Sawai Man Singh medical college and Attached hospital, Jaipur Rajasthan 302004 ,India. |
| Type of Sponsor |
Government medical college |
|
|
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 Samridhi Nanda |
General surgery OT,Gastro OT,Hand surgery OT,Trauma centre OT |
Department of Anaesthesia,1st floor OT complex, Dhanwantri OPD building,S.M.S medical college and attached hospitals,Jaipur
Jaipur
RAJASTHAN |
9680565399
samridhinanda@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of the ethics commitee,S.M.S medical college and attached hospitals,Jaipur |
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 |
| Intervention |
Ultrasound guided venous cannulation |
Ultrasound guided venous cannulation in long axis orientation |
| Comparator Agent |
Ultrasound guided venous cannulation |
Ultrasound guided venous cannulation in short axis orientation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA Grade 1,2 cases presenting for surgery/ procedures
2. Patients providing informed written consent to the procedure |
|
| ExclusionCriteria |
| Details |
1. Patients with history of coagulopathy, or are on blood thinning medications at
the time of the procedure.
2. Patients who have generalized edema or other indication precluding
peripheral venous cannulation
4. Patients with a mental or verbal incapacity to express
5. Patient should not be part of any other study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean VAS scale (VAS-P: pain of procedure) in either groups |
At the time of cannulation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess & compare the time taken to do a peripheral venous cannulation in either approaches.
2. To assess & compare the ease of peripheral venous cannulation in either approaches in terms of rate of first pass success, number of needle passes prior to success in either approaches
3. To assess & compare the proportion of cases having an orientation crossover,site crossover, operator change
4. To assess & compare proportion of complications/ adverse effects if any |
1. Stopwatch starts just before the attempt to cannulation, upto the point when the Cannula tip is visualised in the lumen in long axis orientation |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/07/2025 |
| 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="0"
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
|
Peripheral venous cannulation is crucial in surgical, emergency, and critical care settings.
Traditionally, intravenous catheters are placed by visualizing or palpating the vein, but up
to one-third of patients encounter difficult intravenous access (DIVA), which includes
those with generalized edema, obesity, multiple previous cannulations, or who are
intravenous drug users.Ultrasound-guided peripheral intravenous access has proven
more successful than blind techniques, reducing time and punctures while improving
patient satisfaction, especially in challenging cases . Real-time ultrasound needle
guidance using the in-plane/long-axis technique enhances needle placement accuracy and
allows for immediate complication checks and catheter tip verification. This method
also decreases the need for central venous catheter placement, particularly in noncritically
ill patients. It can lead to reduced reliance on central venous catheters solely for access
purposes and fewer days with central lines in place. However, studies on the impact of ultrasound orientation (short versus long axis) for
cannulating larger veins have shown inconsistent results. Therefore, we are conducting
a randomized comparative study to evaluate the effect of short-axis versus long-axis
orientation on pain during ultrasound-guided peripheral venous cannulation |