| CTRI Number |
CTRI/2026/01/101133 [Registered on: 14/01/2026] Trial Registered Prospectively |
| Last Modified On: |
06/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing two techniques of administering anaesthesia for upper limb by injecting local anaesthetic drug under ultrasound guidance around the nerves supplying upper limb. The onset of action, duration of action and need for additional analgesia are assessed. |
|
Scientific Title of Study
|
Comparison of the efficacy between Ultrasound guided Supraclavicular brachial plexus block and Infraclavicular brachial plexus block using 0.5 percent Ropivacaine in forearm surgeries - A prospective randomised double blind 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 |
DrAswinK |
| Designation |
DNB resident |
| Affiliation |
SRM Institutes for Medical Sciences (SIMS) |
| Address |
SIMS Institute of Anesthesiology and Pain Services (SIAPS),
SRM Institutes for Medical Sciences (SIMS), Vadapalani, Chennai
Chennai
TAMIL NADU
600026
India |
| Phone |
7338758515 |
| Fax |
|
| Email |
aswinkathirvel181@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Aanand Shankar.B |
| Designation |
Senior Consultant Anesthesiology |
| Affiliation |
SRM Institutes for Medical Sciences (SIMS) |
| Address |
SIMS Institute of Anesthesiology and Pain Services (SIAPS),
SRM Institutes for Medical Sciences (SIMS Hospital),
Vadapalani, Chennai
Chennai
TAMIL NADU
600026
India |
| Phone |
9841440448 |
| Fax |
|
| Email |
draanandshankar80@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrAswinK |
| Designation |
DNB resident |
| Affiliation |
SRM Institutes for Medical Sciences (SIMS) |
| Address |
SIMS Institute of Anesthesiology and Pain Services (SIAPS),
SRM Institutes for Medical Sciences (SIMS Hospital),
Vadapalani, Chennai
Chennai
TAMIL NADU
600026
India |
| Phone |
7338758515 |
| Fax |
|
| Email |
aswinkathirvel181@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SRM Institutes for Medical Sciences |
| Address |
SRM Institutes for Medical Sciences (SIMS hospital), Vadapalani,Chennai |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| DrAswinK |
SRM Institutes for Medical Sciences(SIMS Hospital) |
SIMS Institute of Anesthesiology and Pain Services (SIAPS)
Chennai
TAMIL NADU |
7338758515
aswinkathirvel181@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, SRM Institutes for Medical Science (SIMS) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ultrasound-guided infraclavicular brachial plexus block with 0.5% ropivacaine |
A single-shot infraclavicular brachial plexus block will be performed under ultrasound guidance using a high-frequency linear probe. Twenty millilitres of 0.5% ropivacaine will be injected in an in-plane lateral-to-medial approach around the brachial plexus cords near the axillary artery after negative aspiration for blood, immediately prior to surgery. |
| Intervention |
Ultrasound-guided supraclavicular brachial plexus block with 0.5% ropivacaine |
A single-shot supraclavicular brachial plexus block will be performed under ultrasound guidance using a high-frequency linear probe. Twenty millilitres of 0.5% ropivacaine will be injected in an in-plane lateral-to-medial approach around the brachial plexus trunks after negative aspiration for blood, immediately prior to surgery. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status grade I or II,Age between 20 and 60 years,Both male and female patients,Body mass index less than 30 kg/m2,Patients admitted for forearm surgeries,Patients willing to participate and provide written informed consent |
|
| ExclusionCriteria |
| Details |
ASA physical status grade III, IV, or V,Age less than 20 years or greater than 60 years,Pregnant or lactating women,Body mass index greater than or equal to 30 kg/m2,Participation in any other clinical study,Known allergy to local anaesthetics or any drugs used in this study,Patients not willing to participate,Presence of bleeding disorder,Presence of infection at the site of block |
|
|
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 |
| Onset time and duration of sensory and motor block assessed using pinprick test and Modified Bromage scale in the radial, median, and ulnar nerve distributions |
Onset assessed every minute from completion of local anaesthetic injection until full block achieved intraoperatively; duration assessed at 30 minute intervals post-procedure until complete recovery, up to 24 hours after block |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time to first request for rescue analgesia, requirement for rescue analgesia in the first 24 hours, Visual Analogue Scale pain scores, and incidence of block-related complications including vascular puncture, pneumothorax, or nerve injury |
Pain scores recorded at 2, 4, 6, 12, and 24 hours postoperatively; rescue analgesia requirement monitored throughout the first 24 hours; complications noted intraoperatively and during the postoperative 24-hour observation period |
|
|
Target Sample Size
|
Total Sample Size="58"
Sample Size from India="58"
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)
|
20/01/2026 |
| 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="0"
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 - NO
|
|
Brief Summary
|
This is a prospective, randomised, double-blinded comparative clinical trial evaluating the efficacy of ultrasound-guided supraclavicular brachial plexus block versus ultrasound-guided infraclavicular brachial plexus block in adult patients undergoing forearm surgeries. Fifty-eight patients aged 20 to 60 years with ASA physical status I or II will be enrolled and allocated to one of the two groups using computer-generated randomisation. Both groups will receive 20 mL of 0.5% ropivacaine as a single-shot injection under ultrasound guidance. The primary outcome measures are onset time and duration of sensory and motor block. Secondary outcomes include time to first request for rescue analgesia, total rescue analgesic requirement in the first 24 hours, postoperative pain scores, and block-related complications. Assessments will be conducted intraoperatively and up to 24 hours post-procedure. |