| CTRI Number |
CTRI/2023/10/058562 [Registered on: 12/10/2023] Trial Registered Prospectively |
| Last Modified On: |
07/10/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing two medicines for relieving pain due to needle prick for glucose drip |
|
Scientific Title of Study
|
Comparison of two different techniques of analgesia for intravenous cannulation: A randomised controlled 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 Shagun Bhatia Shah |
| Designation |
Senior Consultant Anaesthesiologist |
| Affiliation |
Rajiv Gandhi Cancer Institute and Research Centre |
| Address |
Department of Anaesthesia;Third Floor; Major Operation Theatre Division; Consultants Room; Rajiv Gandhi Cancer Institute and Research Centre Sector-5 ; Rohini
North West
DELHI
110085
India |
| Phone |
09891769779 |
| Fax |
|
| Email |
drshagun_2010@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shagun Bhatia Shah |
| Designation |
Senior Consultant Anaesthesiologist |
| Affiliation |
Rajiv Gandhi Cancer Institute and Research Centre |
| Address |
Department of Anaesthesia;Third Floor; Major Operation Theatre Division; Consultants Room; Rajiv Gandhi Cancer Institute and Research Centre Sector-5 ; Rohini
North West
DELHI
110085
India |
| Phone |
09891769779 |
| Fax |
|
| Email |
drshagun_2010@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shagun Bhatia Shah |
| Designation |
Senior Consultant Anaesthesiologist |
| Affiliation |
Rajiv Gandhi Cancer Institute and Research Centre |
| Address |
Department of Anaesthesia;Third Floor; Major Operation Theatre Division; Consultants Room; Rajiv Gandhi Cancer Institute and Research Centre Sector-5 ; Rohini
North West
DELHI
110085
India |
| Phone |
09891769779 |
| Fax |
|
| Email |
drshagun_2010@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Rajiv Gandhi Cancer Institute and research Centre; Sector -5; Rohini; Delhi-110085 |
|
|
Primary Sponsor
|
| Name |
Dr Shagun Bhatia Shah |
| Address |
H.No-174-175; Ground Floor ;Pocket -17; Sector-24; Rohini- Delhi-110085 |
| Type of Sponsor |
Other [Self] |
|
|
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 Shagun Bhatia Shah |
Rajiv Gandhi Cancer Institute and Research Centre |
Operation Theatre no:6;Department of Anaesthesia;Operation Theatre Division; Third Floor ;Old Building; Sector-5;Rohini;Delhi-11008 5
North West
DELHI
North West
DELHI |
9891769779
drshagun_2010@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board of Rajiv Gandhi Cancer Institute and Research Centre |
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 |
2% lignocaine injection |
0.5ml of 2% lignocaine shall be injected through a 26gauge hypodermic needle 2 seconds before intravenous cannulation
Duration: 10seconds |
| Intervention |
Vapocoolant Spray |
4 puffs of vapocoolant spray over 2 seconds 2seconds before intravenous cannulation
Duration: 10seconds |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Weighing 40-80kg, undergoing intravenous cannulation with 20G or 18G cannula |
|
| ExclusionCriteria |
| Details |
Refusal to give consent, Local Anaesthetic allergy, Patients requiring more than one attempt for intravenous cannulation |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain visual analog scale (VAS)score |
0 minute: At the time of local anaesthetic prick/vapocoolant spray
1 minute : After local anaesthetic prick/vapocoolant spray at the time of IV cannulation
2 minutes : After local anaesthetic prick/vapocoolant spray |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Anxiety visual analog scale (VAS) score
Heart rate (HR)
Mean arterial pressure (MAP) Perfusion index (PI) |
0 minute: At the time of local anaesthetic prick/vapocoolant spray
1 minute : After local anaesthetic prick/vapocoolant spray at the time of IV cannulation
2 minutes : After local anaesthetic prick/vapocoolant spray |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
23/10/2023 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None so far |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drshagun_2010@rediffmail.com].
- For how long will this data be available start date provided 07-09-2023 and end date provided 07-09-2028?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This prospective interventional, two-arm, single-centric randomised controlled study aims to compare a vapocoolant based no-prick technique of preventing pain due to intravenous cannulation with the local anaesthetic injection technique and shall include 80 adult ASA I-II patients of either sex, aged 18-60 years, weighing 45-80kg, undergoing IV cannulation with 20G or 18G cannula. Exclusion criteria comprise patient refusal to give consent, local anaesthetic allergy and patients requiring more than one attempt for intravenous cannulation. The study will be conducted at Rajiv Gandhi Cancer Institute and Research Centre. The patients shall be randomly allocated into two groups: local anaesthetic injection group (Group-LA; n=40), and vapocoolant spray group (Group-VS; n=40). Our primary outcome measures would be pain score measured on a linear 100mm Visual analog scale (VAS) at the time of local anaesthetic prick/vapocoolant spray, intravenous cannula introduction, and 1min post intravenous cannulation. Our secondary outcome measures would be VAS for anxiety score, heart rate (HR), mean arterial pressure (MAP) and perfusion index (PI) measured at specific time points (baseline, intravenous cannula introduction, and 1min post intravenous cannulation).
|