| CTRI Number |
CTRI/2018/04/013066 [Registered on: 05/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
22/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two regional anaesthetic technique for unilateral lower limb surgeries |
|
Scientific Title of Study
|
Comparison of epidural anaesthsia and combined sciatic-femoral nerve block for unilateral lower limb surgeries. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gautam Gupta |
| Designation |
Primary DNB Anaesthesiology |
| Affiliation |
Bhagat Phool Singh Government Medical College For Women |
| Address |
Operation Theatre Complex
Department Of Anaesthesiology
Bhagat Phool Singh Government Medical College For Women
Khanpur Kalan
Sonipat
Sonipat
HARYANA
131305
India |
| Phone |
8396088608 |
| Fax |
|
| Email |
ggmedico2010@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Saru Singh |
| Designation |
Associate Professor Department of Anaesthesiology |
| Affiliation |
Bhagat Phool Singh Government Medical College For Women |
| Address |
Operation Theatre Complex
Department Of Anaesthesiology
Bhagat Phool Singh Government Medical College For Women
Khanpur Kalan
Sonipat Haryana
Sonipat
HARYANA
131305
India |
| Phone |
8607312112 |
| Fax |
|
| Email |
drsarusingh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gautam Gupta |
| Designation |
Primary DNB Anaesthesiology |
| Affiliation |
Bhagat Phool Singh Government Medical College For Women |
| Address |
Operation Theatre Complex
Department Of Anaesthesiology
Bhagat Phool Singh Government Medical College For Women
Khanpur Kalan
Sonipat Haryana
Sonipat
HARYANA
131305
India |
| Phone |
8396088608 |
| Fax |
|
| Email |
ggmedico2010@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bhagat Phool Singh Government Medical College For Women
Khanpur Kalan
Sonipat Haryana |
|
|
Primary Sponsor
|
| Name |
Bhagat Phool Singh Government Medical College For Women |
| Address |
Bhagat Phool Singh Government Medical College For Women
Khanpur Kalan
Sonipat Haryana
131305 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Gautam Gupta |
Bhagat Phool Singh Government Medical College For Women |
Operation Theatre Complex Department Of Anaesthesiology
Sonipat
HARYANA |
8396088608
ggmedico2010@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
ASA Grade I-III Patients Posted For Lower Limb Surgeries, (1) ICD-10 Condition: S822||Fracture of shaft of tibia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Combined Sciatic Femoral Nerve Block |
The patients will be divided into 2 groups:
1. Group A (CSFB): Sciatic-Femoral block will be given. Drug solution will be prepared with injection Bupivacaine 3mg/kg made up to a volume of 45 ml with normal saline. 30 ml of the drug solution will be given for sciatic nerve block and 15 ml for femoral nerve block.
2. Group B (EA): Epidural Anaesthesia will be given with 15ml of 0.5% Bupivacaine.
Patient will be observed for 24 hours. |
| Comparator Agent |
Epidural Anaesthesia |
The patients will be divided into 2 groups:
1. Group A (CSFB): Sciatic-Femoral block will be given. Drug solution will be prepared with injection Bupivacaine 3mg/kg made up to a volume of 45 ml with normal saline. 30 ml of the drug solution will be given for sciatic nerve block and 15 ml for femoral nerve block.
2. Group B (EA): Epidural Anaesthesia will be given with 15ml of 0.5% Bupivacaine.
Patient will be observed for 24 hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of all gender between 18-65 years of age.
2.American Society of Anaesthesiologists (ASA) grade I to III.
3.Lower limb surgery around and below the knee.
4.No history of uncontrolled chronic illness.
5.Patient who are willing to provide their voluntary written informed consent for participation in the study.
|
|
| ExclusionCriteria |
| Details |
1.Patient unwillingness/ lack of consent.
2.Patient with spine deformity, localized sepsis and raised intracranial pressure.
3.Patients with impaired mentation significant neurological, psychiatric, neuromuscular, cardiovascular, pulmonary, renal or hepatic diseases.
4.History of allergy to drugs under study.
5.Pregnant patients.
6.Morbid obesity (BMI>40 kg/m2).
7.Coagulation disorders.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the success rate of anaesthesia in both the techniques. |
Intraoperative upto a maximum of 3 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcome will be the onset of sensory and motor blockade. |
Time of onset of sensory and motor blockade. |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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)
|
04/02/2018 |
| 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="6"
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
|
Patients comfort and
adequate intraoperative anaesthesia is an anaesthesiologist’s first priority.
Anaesthesiologist have always tried to develop procedures which give patient
more comfort during surgical procedures, have wide safety margin and minimal
risks associated with it. Lower limb surgery is a common surgical procedure and
many anaesthetic techniques like spinal anaesthesia, epidural anaesthesia,
peripheral nerve blocks (both single and multiple nerves) are available to
facilitate the surgery.
The primary objective
of my study is to compare two well established techniques: Epidural and
Combined Sciatic-Femoral nerve block and evaluate which is better in view of
successful intraoperative anaesthesia. Secondarily, haemodynamic stability and
patient comfort will be assessed during the two techniques.
The study will be
carried out on 76 patients scheduled for lower limb surgeries and will be
randomly divided into two groups of 38 each.. In Group A (CSFB), drug solution
for sciatic- femoral block will be prepared with injection Bupivacaine 3mg/kg
made up to a volume of 45 ml with normal saline and patients will receive 30 ml
of the solution for sciatic nerve block and 15 ml for femoral nerve block. In
Group B (EA), patients will receive 15 ml of 0.5% bupivacaine. Adequacy of
intraoperative anaesthesia in terms of success rate, onset and duration of
sensory and motor blocks, haemodynamic parameters and side effects will noted.
Since this is a randomised prospective study, the anticipated outcome cannot be
commented upon. |