| CTRI Number |
CTRI/2024/01/061268 [Registered on: 09/01/2024] Trial Registered Prospectively |
| Last Modified On: |
26/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Using three different volumes of the same local anaesthesia on the pulse oximeter index during upper limb surgeries |
|
Scientific Title of Study
|
The effect of three different volumes of 0.5% bupivacaine on the perfusion index ratio during the ultrasound guided nerve block: A randomised controlled trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Milon Vasant Mitragotri |
| Designation |
Assistant Professor |
| Affiliation |
KARNATAKA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of Anaesthesia, Karnataka Institute Of medical Sciences, Vidyanagar, Hubli-580021.
Dharwad
KARNATAKA
580021
India |
| Phone |
7406796763 |
| Fax |
|
| Email |
milon.mitragotri4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Milon Vasant Mitragotri |
| Designation |
Assistant Professor |
| Affiliation |
KARNATAKA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of Anaesthesia, Karnataka Institute Of medical Sciences, Vidyanagar, Hubli-580021.
KARNATAKA
580021
India |
| Phone |
7406796763 |
| Fax |
|
| Email |
milon.mitragotri4@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Milon Vasant Mitragotri |
| Designation |
Assistant Professor |
| Affiliation |
KARNATAKA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of Anaesthesia, Karnataka Institute Of medical Sciences, Vidyanagar, Hubli-580021.
KARNATAKA
580021
India |
| Phone |
7406796763 |
| Fax |
|
| Email |
milon.mitragotri4@gmail.com |
|
|
Source of Monetary or Material Support
|
| Karnataka Institute of medical Sciences, Vidyanagar, Hubballi-580021. Dharwad district |
|
|
Primary Sponsor
|
| Name |
Karnataka Institute of Medical Sciences |
| Address |
KIMS, Vidyanagar, Hubballi-580021 |
| 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 Milon V Mitragotri |
Karnataka Institute of Medical Sciences, Hubballi |
Room No 206, Department of Anaesthesia, Karnataka Institute Of medical Sciences, Vidyanagar, Hubli-580021.
Dharwad
KARNATAKA |
7406796763
milon.mitragotri4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KARNATAKA INSTITUTE OF MEDICAL SCIENCES ETHICS COMMITTEE |
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 |
10ml Bupivacaine |
10ml of 0.5% Bupivacaine injected for interscalene nerve block just before surgery. |
| Intervention |
15ml bupivacaine |
15ml of 0.5% Bupivacaine injected for interscalene nerve block just before surgery |
| Intervention |
20ml Bupivacaine |
20ml of 0.5% Bupivacaine injected for interscalene nerve block just before surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult patients of either sex aged between 18-60 years.
2. Scheduled for elective upper limb surgery (involving humerus or shoulder) under sole ultrasound guided interscalene block.
3. American society of Anesthesiologists physical status I or II
|
|
| ExclusionCriteria |
| Details |
1. Patients with diabetes mellitus or peripheral vascular disease.
2. Allergy to local anaesthetics.
3. Local site infection
4. Refusal by patient for study.
5. Coagulopathy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Observe the PI ratio before and after interscalene block following 10ml, 15ml and 20ml of 0.5% bupivacaine. |
Baseline and 15minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The cutoff values of PI and PI ratio as predictors of successful block |
Baseline and 15 minutes |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/01/2024 |
| 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)
Modification(s)
|
Open to Recruitment |
| 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
|
Perfusion index (PI) is a new and objective way to
evaluate the success of peripheral nerve block.[1] It can be used as
an alternate means for sensory or motor function tests.
- Many
studies have elucidated that PI changes in increments of double or even
quadraple to signify successful block.
Pardeep et al stated PI>3.2 and PI ratio of > 2.04 at 15min to be
accurate predictors for block success in USG guided interscalene nerve blocks.[2] However many studies give contrasting results
with respect to the cutoff values or the ratio of PI index.
-
- We
hypothesize that the volume of LA used may be one of determining factor in the
cutoff value of PI index for successful nerve block.
|