| CTRI Number |
CTRI/2025/07/091506 [Registered on: 23/07/2025] Trial Registered Prospectively |
| Last Modified On: |
24/07/2025 |
| 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
|
To study the Minimum Effective Dose required to block the Selective truncal brachial plexus for elbow and forearm surgeries. |
|
Scientific Title of Study
|
Selective truncal injection brachial plexus block for elbow and forearm surgeries- 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 P Madhushree |
| Designation |
Post graduate in MD Anaesthesia BMC RC Ballari |
| Affiliation |
Ballari institute of Medical Sciences and Research centre |
| Address |
Post graduate in MD Anaesthesia , Department of anaesthesiology BMCRC Ballari Girls hostel LVG block room number 13 Karnataka 583101
Bellary
KARNATAKA
583104
India |
| Phone |
7795087126 |
| Fax |
|
| Email |
pmadhushree07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kiran Chand N |
| Designation |
Associate Professor BMCRC Ballari |
| Affiliation |
Ballari institute of Medical Sciences and Research centre |
| Address |
Associate professor in department of Anaesthesiology BMCRC Ballari Karnataka 583101
Bellary
KARNATAKA
583101
India |
| Phone |
9845857056 |
| Fax |
|
| Email |
nkiranchand@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr P Madhushree |
| Designation |
Post graduate in MD Anaesthesia BMCRC Ballari |
| Affiliation |
Ballari institute of Medical Sciences and Research centre |
| Address |
Post graduate in MD Anaesthesia, Department of anaesthesiology, BMCRC Ballari Girls hostel LVG block room number 13 Karnataka 583101
Bellary
KARNATAKA
583104
India |
| Phone |
7795087126 |
| Fax |
|
| Email |
pmadhushree07@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Ballari Institute of Medical Sciences and Research centre , Ballari, Karnataka 583104, India. |
|
|
Primary Sponsor
|
| Name |
Ballari institute of Medical Sciences and Research centre Ballari |
| Address |
Post graduate in MD Anaesthesia Department of Anaesthesiology BMCRC Ballari, Karnataka 583104, 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 P Madhushree |
Ballari institute of Medical Sciences and Research centre Ballari |
Department of Anaesthesiology Trauma Care Centre Ballari
Bellary
KARNATAKA |
7795087126
pmadhushree07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics Committee BMCRC Ballari |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S50-S59||Injuries to the elbow and forearm, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Selective Truncal injection Brachial plexus block for elbow and forearm surgeries A DOSE FINDING STUDY |
In this study under USG guidance block performed using the drug 0.5% bupivacaine. First patient will receive 18 ml (6 ml/trunk) of LA. At each injection point, 0.5 ml of LA was used to hydrolocate and ensure that needle tip will not be inside any of the hypoechoic circles (intra-fascicular) but within the hyperechoic CT matrix. In case paraesthesia is complained, needle tip will be repositioned before LA injection. Remaining volume will be injected in 0.5 ml aliquots every 1–2 s to prevent building up of hydrostatic pressure and seeping of LA outside the trunk. We will inject UT and MT before LT to delineate their components at the supraclavicular fossa, thereby enabling clear identification of LT the corner pocket. Dixon and Mood up-and-down study design (15) will be followed. 11
LA volume for subsequent patient will be determined by success or failure of block performed in the previous patient. Drug volume will be increased by 3 ml (1 ml/trunk) in case of block failure and decreased by 3 ml in case of block success. This will be continued till 10 up-downs. Block failure will be managed by performing rescue blocks at axilla or providing general anaesthesia
Final needle removal time will be noted as Block Time. Block assessment will be done at 5-min intervals by an independent observer who will be blinded to LA volume and the drug used. This sensory and motor assessments will be continued upto 40 min after the completion of the last injection. |
| Intervention |
SELECTIVE TRUNCAL INJECTION BRACHIAL PLEXUS BLOCK FOR ELBOW AND FOREARM SURGERIES- A DOSE FINDING STUDY |
In this study, Under USG guidance block is performed using the drug 0.5% bupivacaine. First patient will receive 18 ml (6 ml/trunk) of LA. At each injection point, 0.5 ml of LA was used to hydrolocate and ensure that needle tip will not be inside any of the hypoechoic circles (intra-fascicular) but within the hyperechoic CT matrix. In case paraesthesia is complained, needle tip will be repositioned before LA injection. Remaining volume will be injected in 0.5 ml aliquots every 1–2 s to prevent building up of hydrostatic pressure and seeping of LA outside the trunk. We will inject UT and MT before LT to delineate their components at the supraclavicular fossa, thereby enabling clear identification of LT the corner pocket. Dixon and Mood up-and-down study design (15) will be followed. 11
LA volume for subsequent patient will be determined by success or failure of block performed in the previous patient. Drug volume will be increased by 3 ml (1 ml/trunk) in case of block failure and decreased by 3 ml in case of block success. This will be continued till 10 up-downs. Block failure will be managed by performing rescue blocks at axilla or providing general anaesthesia
Final needle removal time will be noted as Block Time. Block assessment will be done at 5-min intervals by an independent observer who will be blinded to LA volume and the drug used. This sensory and motor assessments will be continued upto 40 min after the completion of the last injection. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1 Adult patients aged between 18 and 65 years
2 Scheduled for elective upper limb surgery requiring brachial plexus block
3 Classified as American Society of Anesthesiologists (ASA) physical status I to III
4 Willing and able to provide written informed consent
5 Cooperative and able to communicate effectively during the procedure
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Success rate of Surgical Block MEV90 estimation |
Block is assessed every 5 minutes till 40 min 0min 5 min 10 min 15 min 20 min 25 min 30 min 35 min 40 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Sensory block onset time
Motor Block Onset Time
Duration of sensory and motor block
Patient satisfaction score |
It is assessed for 40min after block and before incision |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
02/08/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - 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
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [pmadhushree07@gmail.com].
- For how long will this data be available start date provided 02-08-2025 and end date provided 02-12-2026?
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
|
Selective Truncal Injection Brachial Plexus Block for Elbow and Forearm Surgeries A Dose Finding Study
This prospective, double-blind, dose-finding clinical study aims to evaluate the efficacy and safety of a selective truncal injection technique for brachial plexus block, specifically targeting the upper, middle, and lower trunks under ultrasound guidance, for patients undergoing elbow and forearm surgeries.
The primary objective is to determine the minimum effective volume (MEV90) of 0.5% bupivacaine required to achieve a successful block in 90% of patients. The study also assesses onset times, duration of sensory and motor block, patient and surgeon satisfaction, and monitors for procedure-related complications.
Patients aged 18–65 years, ASA physical status I–III, undergoing elective upper limb surgeries are included. Exclusion criteria involve factors like coagulopathy, allergy to local anesthetics, severe pulmonary disease, and BMI >35 kg/m². After ethical approval and consent, block performance is standardized using a high-frequency ultrasound to accurately identify and inject local anesthetic around the trunks of the brachial plexus.
A Dixon and Mood Up-and-Down design is used to adjust LA volume per patient response (success/failure), with Probit and logistic regression analysis employed to determine MEV90 and MEV95. A sample size of 44 to 66 patients is anticipated, considering dropout rates.
Success is defined as achieving a composite score of 20/20 (sensory + motor block) within 40 minutes without requiring conversion to another anesthetic technique.
The study contributes significantly to the refinement of regional anesthesia techniques, potentially improving patient outcomes and minimizing complications in upper limb surgeries.
|