| CTRI Number |
CTRI/2024/07/071551 [Registered on: 30/07/2024] Trial Registered Prospectively |
| Last Modified On: |
26/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparison of two different spinal techniques in surgeries below umbilicus. |
|
Scientific Title of Study
|
A comparison of efficacy and saftey of fractional spinal anaesthesia versus conventional spinal anaesthesia with 0.5 percent hyperbaric bupivacaine and fentanyl in patients undergoing infra umbilical and lower limb surgeries. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR SHREYA VEKARIYA |
| Designation |
ANAESTHESIOLOGY 1ST YEAR PG RESIDENT |
| Affiliation |
GMERS MEDICAL COLLEGE AND HOSPITAL |
| Address |
Anesthesia department, Civil hospital, GMERS gandhinagar.
Gandhinagar GUJARAT 382016 India |
| Phone |
9429786682 |
| Fax |
|
| Email |
shreyavekaria@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR HINA GADANI |
| Designation |
ANAESTHESIOLOGY ASSOCIATE PROFESSOR |
| Affiliation |
GMERS MEDICAL COLLEGE AND HOSPITAL |
| Address |
Anesthesia department, Civil hospital, GMERS gandhinagar.
Gandhinagar GUJARAT 382016 India |
| Phone |
8690501339 |
| Fax |
|
| Email |
hinagadani@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DR HINA GADANI |
| Designation |
ANAESTHESIOLOGY ASSOCIATE PROFESSOR |
| Affiliation |
GMERS MEDICAL COLLEGE AND HOSPITAL |
| Address |
Anesthesia department, Civil hospital, GMERS gandhinagar.
Gandhinagar GUJARAT 382016 India |
| Phone |
8690501339 |
| Fax |
|
| Email |
hinagadani@gmail.com |
|
|
Source of Monetary or Material Support
|
| GMERS Medical College And Hospital
Sector 12
Pathikashram road
Gandhinagar, India
Pin code- 382016 |
|
|
Primary Sponsor
|
| Name |
GMERS Medical College And Hospital Gandhinagar |
| Address |
Sector 12
Pathikashram road
Gandhinagar - India
Pin code - 382016 |
| Type of Sponsor |
Government 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 Shreya Vekariya |
GMERS Medical College And Hospital Gandhinagar |
1st floor
Anaesthesia department
600 Bed hospital building
Sector 12
Pathikashram road
Gandhinagar, India
Pin code- 382016 Gandhinagar GUJARAT |
9429786682
shreyavekaria@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee GMERS Medical College, Gandhinagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional spinal anaesthesia |
Conventional spinal anesthesia is a type of regional anesthesia commonly used for surgeries involving the lower half of the body
Conventional patients will be administered a single bolus dose of 3.5 ml (3.0 ml i.e. 15 mg hyperbaric bupivacaine + 0.5 ml i.e. 25 mcg fentanyl)
Patient will be turned to supine position soon
after the completion of spinal anaesthesia injection.
This intervention require 6 to 7 months. |
| Intervention |
Fractional spinal anaesthesia |
Fractional spinal patients will be administered a
fractionated dose of 3.5 ml (3.0 ml i.e. 15 mg hyperbaric bupivacaine + 0.5 ml i.e. 25 mcg fentanyl) with 2.4 ml of
the total dosage given initially, the syringe will be kept attached to the spinal needle for remaining 90
seconds, after which remaining dose, i.e. 1.1 ml will be administered. Patient will be turned to supine position soon
after the completion of spinal anaesthesia injection.
This intervention require 6 to 7 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiology (ASA) Grade I & II
weight: 50 – 80 Kgs.
height: 150 – 170 cms
Patients posted for infra-umbilical and lower limb surgery |
|
| ExclusionCriteria |
| Details |
Patient refusal for study
Patient with clinically significant Coagulopathy
Patient with spine deformities
Patients with infection at site of Spinal Injection
Patients with associated systemic diseases e.g. hypertension, diabetes mellitus, kidney diseases,
respiratory diseases, cardiovascular diseases, liver disease.
Patients with history of allergy to local anaesthetics and opioids
Pregnant and lactating females
Patients who have history of drug abuse
Psychologically challenged patients
Non cooperative patient |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To compare the intra-operative hemodynamic changes in fractional spinal anaesthesia and
conventional spinal anaesthesia (Heart Rate, Systolic blood pressure, Diastolic blood pressure, Mean
Arterial Blood Pressure, SpO2%).
2. To compare the sensory blockade parameters (time of onset of sensory blockade, time of peak
level of sensory blockage and duration of sensory blockade) between fractional spinal anaesthesia and
conventional spinal anaesthesia.
3. To compare the motor blockade parameters (time of onset of motor blockade, duration of motor
blockade) between fractional spinal anaesthesia and conventional spinal anaesthesia .
4. To compare the duration of analgesia between fractional spinal anaesthesia and conventional
spinal anaesthesia. |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study side effects in patients undergoing fractional spinal anaesthesia and conventional spinal
anaesthesia. |
2 years |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
12/08/2024 |
| 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) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Spinal anaesthesia is usually performed anaesthesia technique for infraumbilical and lower limb surgeries. It provides sensory as well as motor blockade. Spinal anaesthesia continues to dominate the field of anaesthesiology because of its rapid onset, simplicity and low complications compared to general anaesthesia. Multiple local anaesthetic agents were used over a period of time. Hyperbaric Bupivacaine 0.5% being the most used one due to its longer duration of action and addition of adjuvant further increased the duration of spinal anaesthesia. Different adjuvants cause different changes in hemodynamic parameters, sensory blockade, motor blockade and analgesia. Fentanyl is a synthetic opioid drug, which is most commonly added as an adjuvant in intrathecal injection because it is more potent, providing better analgesia, hemodynamic stability with better safety profile.
Spinal anaesthesia causes a sympathetic denervation resulting in hypotension because of the rapid sympathetic block.In the conventional technique of spinal anaesthesia bolus dose of drug which many a times gives higher level of anaesthesia than the desired, thus causes more hypotension. In comparison to this, if the drug is administered in two or more divided doses (fractionated doses) in the subarachnoid space rather than entire dose being injected as one dose, occurence of hypotension is reduced.
Fractional spinal anaesthesia technique has been recently introduced. In fractional technique of spinal anaesthesia, after giving 1st fractionated dose , the drug will settle down as the patient to be kept in sitting position for 30-90 seconds, so desired and predicted sensory and motor blockade to be achieved. Then after 2nd fractionated dose is injected and after giving 2nd fractionated dose the patient to be made supine which leads to slow distribution of the drug which prevents hypotention and provides better hemodynamic stability. Fractional spinal anaesthesia is used for a number of surgical procedures because of more hemodynamic stability, longer duration of sensory and motor blockade and longer duration of analgesia in camparison to conventional spinal anaesthesia.
Few studies have been done and published comparing both of these techniques, fractional v/s conventional spinal anaesthesia. Both of these techniques of spinal anaesthesia are used interchangeably in our institute. But, the data collection on comparing both of these techniques has not been done previously. The data being collected from this study, might be helpful for establishing some beneficial and advanced/recent protocol in the anaesthesia department, thereby to the institute and anaesthesia society also. So, the present study will be conducted to compare the efficacy and safety of fractional spinal anaesthesia v/s conventional spinal anaethesia using hyperbaric bupivacaine 0.5% (3ml–15mg) as a local anaesthetic and fentanyl (0.5ml-25mcg) as an adjuvant in patients of infraumbilical and lower limb surgeries. |