| CTRI Number |
CTRI/2025/07/092090 [Registered on: 31/07/2025] Trial Registered Prospectively |
| Last Modified On: |
31/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative Study Between Two Different Approaches to Nerve Block With Local Anaesthetic For Elective Forearm And Hand Surgeries |
|
Scientific Title of Study
|
A Randomized Comparative Study Between Ultrasound Guided Supraclavicular & Infraclavicular Approaches to Brachial Plexus Block With 0.5 percent Ropivacaine for Elective Forearm and Hand Surgeries |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrVickey |
| Designation |
Resident anaesthesiology |
| Affiliation |
pacific medical college and hospital |
| Address |
Department of Anaesthesia and critical care , pacific medical college and hospital, bhilo ka bedla, udaipur.
Udaipur RAJASTHAN 313001 India |
| Phone |
9162062333 |
| Fax |
|
| Email |
vickeysinha8@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Prakash Chandra Audichya |
| Designation |
professor and head of department |
| Affiliation |
pacific medical college and hospital |
| Address |
Department of Anaesthesia and critical care , pacific medical college and hospital, bhilo ka bedla, udaipur.
Udaipur RAJASTHAN 313001 India |
| Phone |
9929721889 |
| Fax |
|
| Email |
prakash.audichya10@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Prakash Chandra Audichya |
| Designation |
professor and head of department |
| Affiliation |
pacific medical college and hospital |
| Address |
Department of Anaesthesia and critical care , pacific medical college and hospital, bhilo ka bedla, udaipur.
Udaipur RAJASTHAN 313001 India |
| Phone |
9929721889 |
| Fax |
|
| Email |
prakash.audichya10@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology and critical care, Pacific Medical College and Hospital, Bhilo ka Bedla Udaipur, Rajasthan -313001 |
|
|
Primary Sponsor
|
| Name |
pacific medical college and hospital |
| Address |
Department of anaesthesiology and critical care, Pacific Medical College and Hospital, Bhilo ka Bedla Udaipur, Rajasthan -313001 |
| Type of Sponsor |
Private 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 |
| Drprakash chandra audichya department of anaesthesilogy |
pacific medical college and hospital ,udaipur |
pacific medical college and hospital , department of anaesthesiology ,bhilo ka bedla,udaipur,rajasthan,313001 Udaipur, RAJASTHAN Udaipur RAJASTHAN |
9929721889
prakash.audichya10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee pacific medical college and hospital udaipur |
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 |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
patients giving informed consent
patients scheduled for elective forearm and hand surgeries
patients weight between 50 kg -80 kg
ASA grade 1 and 2
mallampati grade 3 and 4 |
|
| ExclusionCriteria |
| Details |
patients giving refusal to surgeries
patients having ASA grade 3,4,5
patients with anticipated difficult intubation
patients having mallampati grade 3 and 4
patients allergic to local anaesthetic
patients having coagulation disorder
patients having history of neuropathy
patients having other comorbidity (copd,ihd,hypertension ,diabetes mellitus ,renal hepatic dysfunction ,etc) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to compare the onset time sensory and motor block , duration of sensory as well motor block between supraclavicular and infraclavicular approaches to brachial plexus block |
Intraoperative and postoperative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration of analgesia ,time required for 1st rescue analgesic , incidence & complication if any . |
intraoperative & postoperative period |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
11/08/2025 |
| 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="0" 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
|
A comparative study between ultrasound guided supraclavicular and infraclavicular approaches to brachial plexus block with 0.5 percent ropivacaine for elective forearm and hand surgeries .Efficacy in terms of onset of sensory and motor block ,duration of sensory and motor block ,time taken for first analgesic dose ,Incidence and type of complication if any between two different approaches to brachial plexus block supraclavicular and infraclavicular. |