| CTRI Number |
CTRI/2019/01/017316 [Registered on: 31/01/2019] Trial Registered Prospectively |
| Last Modified On: |
27/05/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Dose of local anaesthetic needed for effective Costoclavicular block |
|
Scientific Title of Study
|
Minimum effective volume of 0.5% Ropivacaine for Ultrasound Guided Costoclavicular block: A dose finding study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ANU KEWLANI |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
PGIMER CHANDIGARH |
| Address |
DEPARTMENT OF ANAESTHESIA AND INTENSIVE CARE, PGIMER, CHANDIGARH
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7710798018 |
| Fax |
|
| Email |
anu.kewlani02@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nidhi Bhatia |
| Designation |
Addl Professor |
| Affiliation |
PGIMER CHANDIGARH |
| Address |
DEPARTMENT OF ANAESTHESIA AND INTENSIVE CARE, PGIMER, CHANDIGARH
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9914207483 |
| Fax |
|
| Email |
nidhi.bhatia75@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ANU KEWLANI |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
PGIMER CHANDIGARH |
| Address |
DEPARTMENT OF ANAESTHESIA AND INTENSIVE CARE, PGIMER, CHANDIGARH
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7710798018 |
| Fax |
|
| Email |
anu.kewlani02@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia and Intensive care, PGIMER, CHANDIGARH |
|
|
Primary Sponsor
|
| Name |
PGIMER Chandigarh |
| Address |
Department of Anaesthesia and Intensive care |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Anu Kewlani |
PGIMER |
Department of Anaesthesia and Intensive care
Chandigarh
CHANDIGARH |
7710798018
anu.kewlani02@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee, PGIMER, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Costoclavicular block |
Different volumes of 0.5% Ropivacaine will be injected to find it’s minimum effective volume required to produce a successful Ultrasound Guided Costoclavicular block in 50% of patients (MEV50) |
| Comparator Agent |
Nil |
There is no comparator agent. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1-2
BMI WITHIN 18-30 kg/m2
Forearm and hand surgeries |
|
| ExclusionCriteria |
| Details |
Local infection at block site
sepsis
obesity (BMI>30)
Coagulopathy
Allergy to local anaesthetic
Renal or hepatic dysfunction
Pre- existing neurological deficits
Prior surgery in the infraclavicular space
Psychiatric illness
Patients who fail to understand the scoring systems used in the study
Uncontrolled hypertension or ischaemic heart disease
Refusal to give consent for the study or block |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the minimum effective volume of 0.5% Ropivacaine required to produce a successful Costoclavicular brachial plexus block for surgical anaesthesia in 50% of the patients ( MEV 50). |
Following block administration, evaluation of sensory and motor block will be performed every 5 min until 30 minutes. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1Block onset time.
2. Block performance time.
3. Number of needle passes.
4. Time to first rescue analgesia.
5. 24 hour total analgesic consumption.
6. Level of block related pain.
7. Occurrence of any adverse event. |
Within 24 hours of block application |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/02/2019 |
| 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="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Purpose of study is to determine the minimum effective volume of 0.5% required to produce a successful Ultrasound Guided Costoclavicular block for surgical anaesthesia in 50% of patients (MEV 50). Sample size is 40. The volume of drug will be determined using the small sample up and down sequential allocation study design of binary response variables as described by Saranteas et al. The stopping rules will include a fixed sample size and demonstration of 5 consecutive up and down sequences. |