| CTRI Number |
CTRI/2025/05/087467 [Registered on: 23/05/2025] Trial Registered Prospectively |
| Last Modified On: |
20/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Dose of drug required for causing numbness to the arm by blocking its nerve |
|
Scientific Title of Study
|
Median Effective Volume of 0.5% Ropivacaine for Ultrasound-Guided Single-Injection Sub-arterial
Axillary Brachial Plexus Block in Extreme Arm Abduction: A Dose Finding 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 Abhinav Sood |
| Designation |
Junior Resident |
| Affiliation |
PGIMER Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care
4th Floor
Nehru Hospital
PGIMER Chandigarh
Sector 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8350930383 |
| Fax |
|
| Email |
soodabhi007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nidhi Bhatia |
| Designation |
Professor |
| Affiliation |
PGIMER Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care
4th Floor
Nehru Hospital
PGIMER Chandigarh
Sector 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9914207483 |
| Fax |
|
| Email |
nidhi.bhatia75@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nidhi Bhatia |
| Designation |
Professor |
| Affiliation |
PGIMER Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care
4th Floor
Nehru Hospital
PGIMER Chandigarh
Sector 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9914207483 |
| Fax |
|
| Email |
nidhi.bhatia75@gmail.com |
|
|
Source of Monetary or Material Support
|
| PGIMER
Sector 12
Chandigarh
India
pin code 160012 |
|
|
Primary Sponsor
|
| Name |
Dept of Anaesthesia and Intensive Care |
| Address |
Department of Anaesthesia and Intensive Care
4th Floor
Nehru Hospital
PGIMER
Sector 12
Chandigarh
India
Pin code 160012 |
| 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 Nidhi Bhatia |
Post Graduate Institute of Medical Education and Research, Chandigarh |
Advanced Trauma Centre
Sector 12
Chandigarh
Chandigarh
CHANDIGARH |
9914207483
Nidhi.bhatia75@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee PGIMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S629||Unspecified fracture of wrist andhand, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Administration of 0.5% Ropivacaine in ultrasound-guided axillary brachial plexus block with arm in extreme hyperabduction |
A sub-arterial injection of 0.5% Ropivacaine will be administered in slow increments while keeping AA in the center.
If the first person receiving the initial volume (24mL) of local anaesthetic achieves a successful block, then the volume of local anaesthetic to be given to the next patient will be decreased by 2mL, whereas block failure will result in an increase of volume by 2mL for next patient.
|
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 or 2
BMI 18 to 30kg/m2
scheduled to undergo forearm and hand surgeries under ultrasound-guided Axillary brachial plexus block.
|
|
| ExclusionCriteria |
| Details |
Coagulopathy
Local Site Infection
Anticoagulant therapy
Allergy to Local Anaesthetics
Preexisting motor or sensory deficit in the operative limb
Denial of permission to participate in the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the Median Effective Dose of 0.5% Ropivacaine required to produce a successful USG-guided single-injection subarterial Axillary block with arm in extreme abduction for providing surgical anesthesia in 95% of the patients (ED95) |
30 minutes following block administration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Block onset time |
every 5 minutes till 30 minutes following block administration |
| Block performance time |
at the time of block administration |
| Number of needle passes |
at the time of block administration |
| Incidence of block success |
30 minutes following block administration |
| Block duration / Time to first request for rescue analgesia |
24 hours |
| Distance between the Musculocutaneous nerve and Axillary Artery |
at the time of block administration |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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
Modification(s)
|
N/A |
|
Date of First Enrollment (India)
|
10/06/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Ultrasound guided Axillary Brachial plexus Block serves as an effective anaesthetic technique for surgeries below the elbow, facilitating postoperative pain management, reducing recovery duration, and promoting early discharge of patients who undergo outpatient procedures. The close proximity of musculocutaneous nerve to axillary artery in extreme arm hyperabduction presents the opportunity to block all four nerves(radial, ulnar, median, and musculocutaneous) with a single sub arterial injection (at 6 o’clock position with respect to axillary artery), as opposed to the previously utilized conventional methods. A single sub arterial injection is known to reduce the number of needle passes, the block performance time, and the risk of nerve needle contact, resulting in decreased potential for neural injury and paraesthesia. Literature is sparse with regards to the median effective dose of local anesthetic (0.5% ropivacaine) required to produce an effective ultrasound guided axillary brachial plexus block, with the arm in extreme abduction, using a single sub-arterial injection, thus enabling blocking all four nerves. We thus conceptualized this dose finding study. The volume of the drug to be injected will be determined by up and down sequential allocation study design of binary response variables. An initial single sub arterial injection of 24 mL of 0.5% Ropivacaine (1 dose level below the presumed target) will be administered in slow increments while keeping axillary artery in the center. If the first person receiving the initial volume (24mL) of local anaesthetic achieves a successful block, then the volume of local anaesthetic to be given to the next patient will be decreased by 2mL, whereas block failure will result in an increase of volume by 2mL for next patient. In order to avoid local anesthetic toxicity, we did not exceed the volume of local anesthetic to more than 40ml of 0.5% Ropivacaine. |