| CTRI Number |
CTRI/2022/11/047733 [Registered on: 28/11/2022] Trial Registered Prospectively |
| Last Modified On: |
24/02/2023 |
| 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
|
Clinical trial to compare nerve block technique and local anaesthesia infiltration for reduction of arterial cannulation pain |
|
Scientific Title of Study
|
The analgesic efficacy of ultrasound guided lateral cutaneous nerve of forearm block compared to lidocaine infiltration during radial artery cannulation: A randomized clinical trial |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chitta Ranjan Mohanty |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences Bhubaneswar |
| Address |
All Institute of Medical Sciences Bhubaneswar
Sijua
751019
Khordha
ORISSA
751019
India |
| Phone |
8280458275 |
| Fax |
|
| Email |
drchitta8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chitta Ranjan Mohanty |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences Bhubaneswar |
| Address |
All Institute of Medical Sciences Bhubaneswar
Sijua
751019
Khordha
ORISSA
751019
India |
| Phone |
8280458275 |
| Fax |
|
| Email |
drchitta8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chitta Ranjan Mohanty |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences Bhubaneswar |
| Address |
All Institute of Medical Sciences Bhubaneswar
Sijua
751019
Khordha
ORISSA
751019
India |
| Phone |
8280458275 |
| Fax |
|
| Email |
drchitta8@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences Bhubaneswar |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Bhubaneswar |
| Address |
AIIMS BBSR
SIJUA 751019 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| All India Institute of Medical Sciences Bhubaneswar |
AIIMS BBSR
SIJUA 751019 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Chitta Ranjan Mohanty |
All India Institute of Medical Sciences Bhubaneswar |
Third floor Operation Theater Complex
Department of Trauma and Emergency
Sijua
Khordha
ORISSA |
918280458275
drchitta8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE ALL INDIA INSTITUTE OF MEDICAL SCIENCES BHUBANESWAR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: W319||Contact with unspecified machinery, (2) ICD-10 Condition: R52||Pain, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
lateral cutaneous nerve of forearm block in the lower arm |
ultrasound guided lateral cutaneous nerve of forearm block will be performed in the lower third of arm with 2-2.5 ml of 1% lignocaine. The block to be performed five minutes before radial arterial cannulation. |
| Comparator Agent |
local lignocaine infiltration |
1% Lignocaine 2-2.5 ml will be infiltrated in the distal forearm at proposed the site of radial artery cannulation. The local anesthesia infiltration to be performed five minutes before radial artery cannulation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I-III undergoing surgeries requiring arterial cannulation for invasive blood pressure monitoring.
The patient who can understand and communicate pain scores in NRS.
Visualization of LCNF in ultrasound. |
|
| ExclusionCriteria |
| Details |
Patient refusal
Infection at the planned cannulation site
Known allergies or intolerances to local anesthetics, and occlusion of the ipsilateral ulnar artery.
More than 3 attempts for cannulation, |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of pain score in Numerical Rating Scale during radial artery cannulation in both groups of patients |
One minute after performing successful cannulation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Subjective discomfort (pain score in NRS) during lateral cutaneous nerve of forearm block and local lignocaine infiltration. |
One minute after performing the block. |
| First attempt success rate in either group |
Five minutes after performing successful radial artery cannulation. |
| Patient satisfaction in either group |
In the post-operative period |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
28/11/2022 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Will be published after completion of study |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This randomized controlled study will compare the analgesic efficacy of ultrasound-guided lateral guided lateral cutaneous nerve of forearm block and local lignocaine infiltration for controlling pain during radial artery cannulation. One hundred patients of either gender who required radial artery cannulation before induction of general anesthesia will be recruited for this study. |