| CTRI Number |
CTRI/2016/10/007370 [Registered on: 17/10/2016] Trial Registered Retrospectively |
| Last Modified On: |
22/10/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Trial to find out minimum effective volume of local anaesthetic in ultrasound guided nerve block for forearm surgeries |
|
Scientific Title of Study
|
Estimation of minimum effective volume of ropivacaine 0.5% in ultrasound guided supraclavicular brachial plexus nerve block: a prospective clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pushpender Sangwan |
| Designation |
Postgraduate student |
| Affiliation |
Dr.S.N.Medical College |
| Address |
Near Swaraj tractor agency
Loharu road Uttam nagar
Bhiwani (Haryana)
Bhiwani
HARYANA
127021
India |
| Phone |
8003890070 |
| Fax |
|
| Email |
drsangwan25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dilip Singh Chouhan |
| Designation |
Senior Professor |
| Affiliation |
Dr.S.N.Medical College |
| Address |
29, Vidya park, Air force area
Central school road Jodhpur
(Rajasthan)
shastri nagar, residency road jodhpur-342001
Jodhpur
RAJASTHAN
342001
India |
| Phone |
9001991078 |
| Fax |
|
| Email |
dilipsinghdr@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Pushpender Sangwan |
| Designation |
Postgraduate student |
| Affiliation |
Dr.S.N.Medical College |
| Address |
Near swaraj tractor agency loharu road uttam nagar bhiwani (Haryana)
shastri nagar, residency road jodhpur-342001
Bhiwani
HARYANA
127021
India |
| Phone |
8003890070 |
| Fax |
|
| Email |
drsangwan25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr S N Medical College,
residency road, Shastri nagar
Jodhpur (Rajasthan)-342003 |
|
|
Primary Sponsor
|
| Name |
Dr Sampurnanand Medical College |
| Address |
shastri nagar residency road Jodhpur (Rajasthan)-342003 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Pushpender Sangwan |
near swaraj tractor agency loharu road uttam nagar Bhiwani (Haryana)-127021 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sadik Mohammed |
Mathura Das Mathur Hospital, Jodhpur |
Main operation theatre, 1st floor MDM hospital 3/4,shastri nagar Jodhpur
(Rajasthan)-342003
Jodhpur
RAJASTHAN |
9414849733
drmsadik@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee, Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ASA Grade I-II, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
ultrasound guided peripheral nerve block |
ultrasound guided SCBPB were performed to find out MEV of ropivacaine 0.5% |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grade I-II patients without any associated significant pathology (excluding criteria), posted for forearm surgery under above mentioned age group, were included in our study |
|
| ExclusionCriteria |
| Details |
a.Patient’s refusal.
b.Patients with history of bleeding disorders or patients on anticoagulants.
c.Patients with infection at the site of injection.
d.Patients with allergy to LA.
e.ASA grade 3 & 4 patients.
f.Anatomical abnormality at the regional site.
g.Neurodeficit involving brachial plexus.
h.Pregnant women.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)minimum effective volume of ropivacaine
2)duration of analgesia 3) adverse effects. |
assessment of block quality by calculatioin of composite score of bromage scale and duration of analgesia was recorded by patient response. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
Target Sample Size
|
Total Sample Size="29"
Sample Size from India="29"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/02/2016 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="5" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The purpose of study was to find out the minimum effective value of ropivacaine 0.5% in ultrasound guided supraclavicular nerve block. As before introduction of USG, peripheral nerve block techniques were blinded and basicly relied upon anatomic landmarks. Ultrasound method has dramatically decreased the adverse effects associated with blind techniques e.g. pneumothorax, vascular or neural injuries. But, still the minimum effective dose in this technique is not established, hence we tried to discover it. |