| CTRI Number |
CTRI/2017/12/010756 [Registered on: 05/12/2017] Trial Registered Retrospectively |
| Last Modified On: |
31/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare between two techniques of injections to anaesthetise the nerve located on the back of the leg using ultrasound guidance to assess the quality of anaesthesia for surgery. |
|
Scientific Title of Study
|
QUANTITATIVE ASSESSMENT OF ULTRASOUND GUIDED SCIATIC NERVE BLOCK – A COMPARISON OF SINGLE POINT VERSUS TWO POINT INJECTION TECHNIQUE |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tina Mary Thomas |
| Designation |
Junior Resident / Postgraduate |
| Affiliation |
Mahatma Gandhi Medical College & Research Institute |
| Address |
Department of Anaesthesiology
Mahatma Gandhi Medical College and Research Institute
Pondy-Cuddalore Road
Pillaiyarkuppam
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9495950740 |
| Fax |
|
| Email |
acemary90@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kusha Nag |
| Designation |
Associate Professor |
| Affiliation |
Mahatma Gandhi Medical College & Research Institute |
| Address |
Department of Anaesthesiology
Mahatma Gandhi Medical College and Research Institute
Pondy-Cuddalore Road
Pillaiyarkuppam
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9677535174 |
| Fax |
|
| Email |
kushanag@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Tina Mary Thomas |
| Designation |
Junior Resident / Postgraduate |
| Affiliation |
Mahatma Gandhi Medical College & Research Institute |
| Address |
Department of Anaesthesiology
Mahatma Gandhi Medical College and Research Institute
Pondy-Cuddalore Road
Pillaiyarkuppam
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9495950740 |
| Fax |
|
| Email |
acemary90@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Medical College Research Institute |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Medical College Research Institute |
| Address |
Pondy-Cuddalore Main Road
Pillaiyarkuppam,Pondicherry |
| 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 |
| Tina Mary Thomas |
MAHATMA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE |
Department of Anaesthesiology
Pondy-Cuddalore Main Road,Pillaiyarkuppam
Pondicherry
PONDICHERRY |
9495950740
acemary90@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, Patients admitted to Mahatma Gandhi Medical College and Research Institute for foot and ankle surgeries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ULTRASOUND GUIDED SCIATIC NERVE BLOCK – A COMPARISON OF SINGLE POINT VERSUS TWO POINT INJECTION TECHNIQUE
|
Two groups are being used in this study. Group 1 will receive under ultrasound guidance a single injection of 20ml of the local anaesthetic 1.5% of lignocaine with adrenaline behind the thigh. Group 2 will receive a sciatic nerve block using ultrasound where one injection of 10 ml of local anaesthetic 1.5% of lignocaine with adrenaline is injected at a point similar to the point in group 1 and the second injection of 10ml of local anaesthetic 1.5% of lignocaine with adrenaline is injected at a point of 6 cm above the point of first injection both behind the thigh. |
| Intervention |
ULTRASOUND GUIDED SCIATIC NERVE BLOCK – A COMPARISON OF SINGLE POINT VERSUS TWO POINT INJECTION TECHNIQUE
|
Under ultrasound guidance, the nerve that is located on the back of the thigh is anaesthetised with a local anaesthetic at two different points in those patients posted for foot and ankle surgeries. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patients scheduled for foot and ankle surgeries
|
|
| ExclusionCriteria |
| Details |
· Patients not giving consent
· Patients allergic to local anaesthetics
· Patients with coagulopathy
· Pregnant patients
· Patients with neurological deficits and neuromuscular diseases
· Patients with infections at the site of injection
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To quantitatively compare the intensity of sensory block in single point versus two point injection technique during ultrasound guided sciatic nerve block. |
8 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
None |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/02/2017 |
| Date of Study Completion (India) |
30/09/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
We conducted a study on patients who were posted for foot and ankle surgeries. Patients were anaesthetised by injecting local anaesthetic agent behind the thigh using two different injection techniques. 60 patients were recruited for the study and divided into 2 groups of 30 patients. One group received only a single injection of local anaesthetic behind the thigh and the second group received two injections at two different points at the back of the thigh. The density of sensory blockade and motor blockade was compared between the two groups. which of two techniques would result in a fast onset of action for surgical anaesthesia and would result in a longer duration of analgesia post operatively was compared. this was done in view to see which would benefit the patient both during surgery and post operatively so that a reduced usage of sedatives and intravenous analgesia could be achieved.
|