| CTRI Number |
CTRI/2026/02/103470 [Registered on: 09/02/2026] Trial Registered Prospectively |
| Last Modified On: |
20/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Ultrasound nerve block versus lidocaine to reduce pain during radial artery access for emergency coronary angiography |
|
Scientific Title of Study
|
The Analgesic Efficacy of Ultrasound guided Lateral Cutaneous Nerve of Forearm (LCNF) Block Compared to Lidocaine Infiltration during Radial Artery Catheterisation for Emergency Coronary Angiography: 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 Chitta Ranjan Mohanty |
| Designation |
Additional Professor and Head, Department of Trauma & Emergency, |
| Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
Department of Trauma and Emergency, All India Institute of Medical Sciences, Bhubaneswar, Odisha
Khordha
ORISSA
751019
India |
| Phone |
918280458275 |
| Fax |
|
| Email |
tem_chitta@aiimsbhubaneswar.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dhanraj Meena |
| Designation |
Junior Resident (Academic) |
| Affiliation |
All India Institute of Medical Sciences - Bhubaneswar |
| Address |
Department of Trauma and Emergency, AIIMS Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
917689052738 |
| Fax |
|
| Email |
dhanrajmeena7689@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dhanraj Meena |
| Designation |
Junior Resident (Academic) |
| Affiliation |
All India Institute of Medical Sciences - Bhubaneswar |
| Address |
Department of Trauma and Emergency, AIIMS Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
917689052738 |
| Fax |
|
| Email |
dhanrajmeena7689@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Bhubaneswar (institutional support for infrastructure and consumables) |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
AIIMS Bhubaneswar, Sijua, Odisha, 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 Chitta Ranjan Mohanty |
All India Institute of Medical Sciences, Bhubaneswar |
Cath Lab, Department of Cardiology (First floor)
All India Institute of Medical Sciences, Bhubaneswar
Khordha
ORISSA |
918280458275
tem_chitta@aiimsbhubaneswar.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS Bhubaneswar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I00-I99||Diseases of the circulatory system, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparator (Group B): Local infiltration analgesia |
Local infiltration analgesia: 5 mL 2% lidocaine subcutaneous infiltration at the radial artery puncture site |
| Intervention |
Intervention (Group A): Ultrasound guided lateral cutaneous nerve of forearm (LCNF) block |
LCNF block: 3 mL 0.75% ropivacaine injected perineurally under ultrasound guidance |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either sex presenting with acute coronary syndrome requiring emergency coronary angiography via radial artery access; able to provide informed consent (or legally authorized representative where permitted) |
|
| ExclusionCriteria |
| Details |
Patient refusal; known allergy or intolerance to local anaesthetics; infection at planned cannulation site; occlusion of ipsilateral ulnar artery; more than three prior attempts for cannulation; hemodynamically unstable patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Numerical Rating Scale (NRS) pain score during radial artery catheterisation. |
After the completion of radial artery catheterization. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. NRS pain score during LCNF block or lidocaine infiltration (timepoint: After completion of nerve block/local anaesthesia infiltration (during assessment of successful blockage/infiltration)).
2. First attempt success rate (timepoint:
After the completion of radial artery catheterization
)
3. Post procedure analgesia (After the completion of radial artery catheterization and during post-procedure observation. )
4. Radial artery patency(After 24 hours post-procedure)
|
AS MENTIONED IN EACH ACTEGORY |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
16/02/2026 |
| 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 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
|
This single-centre randomized controlled trial at AIIMS Bhubaneswar will compare ultrasound-guided lateral cutaneous nerve of the forearm (LCNF) block with standard subcutaneous infiltration for analgesia during radial catheterization in patients with acute coronary syndrome undergoing emergency coronary angiography. Eighty-four patients, 18-75, will be randomized 1:1 using computer-generated randomization with allocation of concealment by SNOOSE. The primary outcome is pain during radial artery cannulation measured in NRS. |