| CTRI Number |
CTRI/2018/03/012623 [Registered on: 16/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
12/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
To know the minimum amount of anesthetic drug for anesthetizing hand |
|
Scientific Title of Study
|
Estimation of Minimum Effective Volume of Local Anaesthetic(0.75% Ropivacaine) in target intracluster approach of ultrasound guided supraclavicular block. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sirivella prasanna kumar |
| Designation |
Junior resident |
| Affiliation |
All india institute of medical sciences, New delhi. |
| Address |
Department of anesthesiology,pain medicine and critical care,
Room no. 5011,
Academic block,
All india institute of medical sciences,
Ansari nagar,
New delhi
Pin 110029
India
New Delhi
DELHI
110029
India |
| Phone |
8506017482 |
| Fax |
|
| Email |
drsprasannakumar1090@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Babita gupta |
| Designation |
professor |
| Affiliation |
AII INDIA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Room no.5011,
Department of Anesthesiology,pain medicine and critical care,
Academic block,
All india institute of medical sciences,
Ansari nagar,
New delhi,
Pin 110029,
India.
New Delhi
DELHI
110029
India |
| Phone |
9868397815 |
| Fax |
|
| Email |
drbabitagupta@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Babita gupta |
| Designation |
professor |
| Affiliation |
AII india institute of medical sciences, New delhi |
| Address |
Room no.5011,
Department of Anesthesiology,pain medicine and critical care,
Academic block,
All india institute of medical sciences,
Ansari nagar,
New delhi
Pin 110029
India
New Delhi
DELHI
110029
India |
| Phone |
9868397815 |
| Fax |
|
| Email |
drbabitagupta@hotmail.com |
|
|
Source of Monetary or Material Support
|
| All india institute of medical sciences , New delhi |
|
|
Primary Sponsor
|
| Name |
All india institute of medical sciences New delhi |
| Address |
Department of Anesthesiology,pain medicine and criticalcare.
Room no.5011
Academic block.
All india institute of medical sciences ,New delhi |
| 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 |
| Sirivella prasanna kumar |
All india institute of medical sciences ,New delhi. |
Department of Anesthesia,pain medicine and critical care, AB8, 8th floor, All india institute of medical sciences ,New delhi
New Delhi
DELHI |
8506017482
drsprasannakumar1090@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE, ALL INDIA INSTITUTE OF MEDICAL SCIENCES,NEW DELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
PATIENTS UNDERGOING FOREARM AND HAND SURGERIES, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Ultrasound guided Supraclavicular brachial plexus block |
Injection of 0.75% Ropivacaine, Study starts with a dose of 20 ml and according to the success or failure of the block drug dose is reduced or increased in the next patient respectively,making sure that the dose not exeeding the toxic dose of the Ropivacaine for the weight of the patient.
the drug is administered one time and the drug is injected by using a needle around the nerves of brachial plexus under ultrasound guidance and duration of anesthesia and analgesia is assessed for 24 hours
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing forearm and hand surgeries between ages 18 to 65 years.
American society of anesthesiologists grade 1 and 2.
bodymass index 20-35 kg/m2 |
|
| ExclusionCriteria |
| Details |
Patients refusal.
Surgeries lasting more than 2 hours in duration.
Known allergy to local anesthetic.
Diagnosed nerve injury of the operating limb.
Pregnancy.
Anatomical abnormalities of operating shoulder and hand.
Infection at the injection site. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Estimation of minimum effective volume of local anethetic(0.75% Ropivacaine) in "target intracluster approach" of ultrasound guided supraclavicular block |
we assess for the effectiveness of block for 30 mins after giving the block and we assess duration of analgesia postoperatively at immediate postoperative period ,at 4 hours,8 hours, 12 hours and 24 hours of postoperative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.TIME OF ONSET OF ANESTHESIA
2.DURATION OF ANALGESIA
3.DIFFERENTIAL MOTOR AND SENSORY BLOCKADE
4.TIME OF REQUIREMENT OF RESCUE ANALGESIA
5.ASSESS COMPLICATIONS OF BLOCKADE
|
IMMEDIATE POSTOPERATIVE PERIOD
2 HOURS POST SURGERY
4 HOURS POST SURGERY
6 HOURS POST SURGERY
12 HOURS POST SURGERY
24 HOURS POST SURGERY |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
12/04/2017 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a prospective dose estimation study for assessing the minimum effective volume of local anesthetic(0.75% Ropivacaine ) in target intra-cluster approach of of ultrasound guided supraclavicular block in patients undergoing surgeries involving forearm and hand. this study will be conducted in All india institute of medical sciences , New delhi. The primary outcome of the study is to caliculate the minimum volume of Local anesthetic (0.75% Ropivacaine) required for providing surgical anesthesia for forearm and hand surgeries of less than 2 hours duration. Secondary outcome of this study is to assess anesthesia onset time, duration of analgesia for the volume of drug and to assess complications associated with the procedure. |