| CTRI Number |
CTRI/2018/03/012271 [Registered on: 01/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
29/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
TO know the lowest volume of a drug combination to block the nerves of the hand |
|
Scientific Title of Study
|
Estimation of minimum effective local anaesthetic volume for ultrasound guided targeted peritruncal injection brachial plexus block |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| P.G Dissertation/2017/05/79 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sripriya R |
| Designation |
Associate professor |
| Affiliation |
Mahatma Gandhi Medical College and Research Institute |
| Address |
Department of Anaesthesiology
Second floor
Hospital block
Mahatma Gandhi Medical College and Research Institute
Pondicherry Cuddalore ECR, Pillayarkuppam
Pondicherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9365815939 |
| Fax |
|
| Email |
docsripriya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Charulatha R |
| Designation |
Assistant Professor |
| Affiliation |
Mahatma Gandhi Medical College and Research Institute |
| Address |
Department of Anaesthesiology
Second Floor
Hospital BLock
Mahatma Gandhi Medical College and Research Institute
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9894909652 |
| Fax |
|
| Email |
ravindrancharulatha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Charulatha R |
| Designation |
Assistant Professor |
| Affiliation |
Mahatma Gandhi Medical College and Research Institute |
| Address |
Department of Anaesthesiology
Second Floor
Hospital BLock
Mahatma Gandhi Medical College and Research Institute
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9894909652 |
| Fax |
|
| Email |
ravindrancharulatha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Medical College and Research Institute
Pondicherry Cuddalore ECR, Pillayarkuppam, Puducherry 607402 |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Medical College and Research Institute |
| Address |
Pondicherry Cuddalore ECR, Pillayarkuppam, Puducherry 607402 |
| 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 |
| Dr Gobinath J |
Mahatma Gandhi Medical College and Research Institute |
Department of Anaesthesiology
Second floor
Hospital block
Pondicherry Cuddalore ECR, Pillayarkuppam, Puducherry 607402
Pondicherry
PONDICHERRY |
8098023218
gobigopi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Medical College and Research institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Male patients age between 20 and 40 years with below elbow fractures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Targeted intratruncal injection of brachial plexus and estimation of minimum effective volume using Masseys up and down method |
Dixon and massey’s up and down methodology will be followed to determine the minimum effective volume in 50% of patients. The first patient will receive a block volume of 18 ml of 2%lignocaine with adrenaline and 0.5% bupivacaine 50:50 mixture. The volume for the subsequent patient will be determined by success or failure of the block. The drug volume will be increased by 3 ml in case of block failure and decreased by 3 ml in case of block success. This will be continued till 3 consecutive up and downs are observed. After three consecutive up and downs are observed, the drug volume will be altered by 1.5 ml and study continued till three consecutive up- downs are observed. The mid point of the down to up values will be taken as minimum effective volume in 50 % of individuals. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Male |
| Details |
ASA 1 and 2
Patients posted for bony surgery below elbow |
|
| ExclusionCriteria |
| Details |
1) Patient refusal for the block
2) History of bleeding disorders
3) Local infection at the site of block
4) Pre-existing neurological deficit
5) Respiratory compromise.
6) Known allergy to local anaesthetic drug.
7) Patients in whom the supraclavicular sono-anatomy is not clear.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| volume of mixture of 2 % lignocaine with adrenaline and bupivacaine that can produce a successful motor and sensory block at 30 minutes. |
Assessment of sensory and motor block every 10 minutes upto 30 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration of analgesia |
Every 2 hrs till 6 hours |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "21"
Final Enrollment numbers achieved (India)="21" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
25/05/2017 |
| Date of Study Completion (India) |
31/07/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/07/2019 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
When using LA to
provide surgical anesthesia , we need to provide
1. Dense blockade
2. The duration of block should be such that it covers
the entire duration of surgery and also provides adequate pain relief during
the immediate post –operative period.
Our previous experience with supraclavicular
brachial plexus block, has shown that lignocaine- bupivacaine combination can
satisfy these two requirements.
The previous study by Trans
etal, (3) have reported that 23 ml of the drug
combination is the MEV required to produce block in 50 % of patients and MEV 95
is 42 ml.
We are however able to produce block in all patients
by using 20 ml of the drug combination. So we decided to conduct this study to estimate the minimum effective volume to produce effective block using Masseys up and down method and hence determine the ED 95 |