| CTRI Number |
CTRI/2025/10/095925 [Registered on: 13/10/2025] Trial Registered Prospectively |
| Last Modified On: |
12/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Lignocaine with Adrenaline and Ropivacaine Combination versus Ropivacaine alone for Nerve Block in Hand and Forearm Surgeries |
|
Scientific Title of Study
|
Comparison of Block Characteristics of An Equal Mixture of 2% Lidocaine with Adrenaline And 0.5% Ropivacaine Versus 0.5% Ropivacaine Alone for Ultrasound Guided Axillary Brachial Plexus Block: A Double-Blinded Randomised Controlled Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Krishna Kanhaiya |
| Designation |
DNB Trainee Post MBBS |
| Affiliation |
Northern Railway Central Hospital, New Delhi |
| Address |
Second floor, C19, C block Malviya Nagar South Delhi
New Delhi
DELHI
110017
India |
| Phone |
8863910674 |
| Fax |
|
| Email |
imkanhaiyakrishna@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sushil Krishnan |
| Designation |
Assistant Chief Health Director |
| Affiliation |
Northern Railway Central Hospital, New Delhi |
| Address |
Department of Anaesthesia, Northern Railway Central Hospital, Basant lane New Delhi
New Delhi
DELHI
110055
India |
| Phone |
9717630552 |
| Fax |
|
| Email |
dr.sushilkrishnan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sushil Krishnan |
| Designation |
Assistant Chief Health Director |
| Affiliation |
Northern Railway Central Hospital, New Delhi |
| Address |
Department of Anaesthesia, Northern Railway Central Hospital, Basant lane New Delhi
New Delhi
DELHI
110055
India |
| Phone |
9717630552 |
| Fax |
|
| Email |
dr.sushilkrishnan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Northern Railway Central Hospital, Basant lane,New Delhi110055 |
|
|
Primary Sponsor
|
| Name |
Northern Railway Central Hospital |
| Address |
Basant lane , New Delhi 110055 |
| 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 Krishna Kanhaiya |
OT Complex, Ward no. 5, Department of Anaesthesia, Northern Railway Central Hospital |
Northern Railway Central Hospital, Basant lane, New Delhi 110055
New Delhi
DELHI |
8863910674
imkanhaiyakrishna@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Northern Railway Central Hospital, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S62||Fracture at wrist and hand level, (2) ICD-10 Condition: S52||Fracture of forearm, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.5% Ropivacaine for Axillary brachial plexus block |
Total volume of 0.4ml/kg of 0.5% Ropivacaine for Ultrasound guided Axillary brachial plexus block |
| Intervention |
Equal Mixture of 2% Lidocaine with Adrenaline and 0.5% Ropivacaine for Axillary brachial plexus block |
Total volume with dose of 0.4ml/kg of an Equal Mixture of 2% Lidocaine with Adrenaline and 0.5% Ropivacaine for Ultrasound guided Axillary Brachial plexus block |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients (18-65 years) in need of upper limb anaesthesia for undergoing orthopaedic surgeries at elbow and below under axillary brachial plexus block.
American Society of Anaesthesiologists I and II physical status.
Body weight within BMI less than or 30 kg/m²
|
|
| ExclusionCriteria |
| Details |
Allergy to local anesthetics.
Pre-existing neuropathy or brachial plexus injury.
Coagulopathy or anticoagulant use.
Pregnancy or lactation.
Patient refusal.
Known case of Renal failure.
Known case of Hepatic failure.
Evidence of infection at axillary area
Patients unable to abduct the operative arm
Patients receiving general anaesthesia
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of ONSET TIME of complete conduction blockade in both the groups (defined in minutes, as the time from end of needling to the time required to reach a minimum score of 14/16 using a sensorimotor composite scale.) |
at regular intervals of 2 minutes, till a composite sensorymotor score of 14/ 16 is achieved |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Durantion of Sensory Block
|
Defined in hours, as the time from inability to perceive cold sensation when tested with an alcohol swab to the point where patient first reported return of pain/itching/other sensation |
| Duration of motor block |
defined in hours,as the tume from inability to perform specific voluntary motor functions of upper limbs like wrist flexion or extension/ thumb adduction/ elbow flexion to the point where first voluntary movements are observed. |
| Success rate of block (need for supplementation or conversion to general Anaesthesia) |
inability to achieve a composite sensorymotor score of less than 14 in 30 mins. |
| To assess any adverse effects |
|
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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 4 |
|
Date of First Enrollment (India)
|
31/10/2025 |
| 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="11"
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
|
Regional anaesthesia, particularly Axillary brachial plexus block (ABPB) using ultrasound guided technique is commonly used for orthopaedic surgeries below the elbow . Use of appropriate drugs can determine the intraoperative effectiveness and postoperative analgesia, leading to improved patient care as well as better utilization of resource setting. Recent studies have advocated the use of mixtures of lidocaine with adrenaline and ropivacaine over ropivacaine alone in various nerve blocks, we intend to compare it in ABPB for below elbow surgical procedures. Patients will be divided in two groups with one receiving equal mixture of lidocaine with adrenaline and ropivacaine while the other group will receive ropivacaine only for ultrasound guided ABPB. Both drugs have certain advantages, Lidocaine offers a quick onset, ropivacaine extends the duration of postoperative analgesia, maintaining pain relief for several hours after the procedure. Therefore the duration of onset time of blocks of both groups will be compared. A total of 62 patients will be divided in two groups with 31 each for a randomized double-blinded controlled trial to compare the blocks in two groups.
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