| CTRI Number |
CTRI/2024/08/072089 [Registered on: 07/08/2024] Trial Registered Prospectively |
| Last Modified On: |
07/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Adjusting local anaesthetic levels in spinal anaesthesia for safer and more comfortable ceasarean section- A study |
|
Scientific Title of Study
|
Efficacy of level adjusted local anaesthetic dose for subarachnoid block in elective caesarean section -A randomised trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Balaji Chenthil |
| Designation |
Postgraduate |
| Affiliation |
SBV Deemed to be university |
| Address |
Department of anaesthesiology,
Mahatma Gandhi Medcal College,
Pondicherry.
Pondicherry PONDICHERRY 607403 India |
| Phone |
8220191465 |
| Fax |
|
| Email |
balajichenthil@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Parthasarathy S |
| Designation |
Professor |
| Affiliation |
SBV deemed to be university |
| Address |
Department of anaesthesiology,
Mahatma Gandhi Medical College,
Pondicherry.
Pondicherry PONDICHERRY 607403 India |
| Phone |
9443142582 |
| Fax |
|
| Email |
painfreepartha@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Balaji Chenthil |
| Designation |
Postgraduate |
| Affiliation |
SBV Deemed to be university |
| Address |
Department of anaesthesiology,
Mahatma Gandhi Medical College,
Pondicherry.
Pondicherry PONDICHERRY 607403 India |
| Phone |
8220191465 |
| Fax |
|
| Email |
balajichenthil@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology,
Mahatma Gandhi Medical College,
Pondicherry-607402,India |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Medical College |
| Address |
Department of anaesthesiology,
Mahatma Gandhi Medical College,
Pondicherry-607402,India |
| 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 |
| Dr Balaji Chenthil |
Mahatma Gandhi Medical College |
Department of anaesthesiology,
Mahatma Gandhi Medical College,
Pondicherry. Pondicherry PONDICHERRY |
8220191465
balajichenthil@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee,MGMCRI,Puducherry-607402 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O746||Other complications of spinal andepidural anesthesia during labor and delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Spinal anaesthesia with Inj.0.5% Hyperbaric Bupivacaine |
Spinal level - L2-L3 - 2ml of the drug given intrathecally
|
| Comparator Agent |
Spinal anaesthesia with Inj.0.5% Hyperbaric Bupivacaine |
Spinal level - L3-L4 - 2.2ml of the drug given intrathecally |
| Comparator Agent |
Spinal anaesthesia with Inj.0.5% Hyperbaric Bupivacaine |
Spinal level - L4-L5 - 2.4ml of the drug given intrathecally |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1.Term pregnancy (37 weeks)
2.Category IV - Planned for elective LSCS
3.Category III - Needing early delivery but no fetal or maternal compromise
4.Height more than 150 cms
5.ASA II
6.Singleton pregnancy |
|
| ExclusionCriteria |
| Details |
1.Hypertensive disorder complicating pregnancy
2.Cardiovascular illness
3.Fetal abnormalities
4.Height more than 180 cms
5.BMI more than 35
6.Other contraindications for spinal anaesthesia |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate the incidence of hypotension following subarachnoid block with three different doses of bupivacaine at three different levels. |
At 1,2,4,6,8,10,12,15,20,25,30,35,40,60,90 minutes following subarachnoid block |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To estimate the spinal level achieved, time to achieve the level, total vasopressor required. |
At 1,2,4,6,8,10,12,15,20,25,30,35,40,60,90 minutes following subarachnoid block |
|
|
Target Sample Size
|
Total Sample Size="300" Sample Size from India="300"
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)
|
26/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
26/08/2024 |
| 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
|
All parturients of category IV will be pre-medicated with tablet pantoprazole 40mg and tablet perinorm 10mg night before and morning of surgery. Parturients belonging to category III will receive oral pantoprazole 40 mg two hours prior to surgery. A 18 gauge intravenous cannula will be inserted and standard monitoring such as non-invasive blood pressure ,saturation and ecg will be established. The base line vitals will be recorded. The patient will then be placed in lateral position. Pre-procedural ultrasound scanning will be done to identify the respective interspace. Then subarachnoid blockade will be administered using 25 g quincke’s needle in group A with 2ml of 0.5% hyperbaric bupivacaine in L2-L3 space , group B with 2.2ml of 0.5%bupivacaine in L3-L4 space, in group C 2.4ml of 0.5%bupivacaine in L4-L5 space. Drug will be loaded in 2.5ml syringe and will be administered at the rate of 0.2ml/sec. All the patients will be coloaded with intravenous crystalloids at 15ml/kg after the administration of intrathecal bupivacaine. Then patient will be placed in supine position. Wedge will be placed for all patients. Supplemental oxygen will be given with face mask at 6l/min. Sensory block assessment will be done with pinprick method and motor assessment will be done by bromage assessment. Desired spinal level is T4-T6. Manoeuvres required to achieve the spinal level such at head down(Trendelenburg position) will be noted. Time taken to achieve the desired level will also be noted. Hemodynamic parameters will be measured at 0,1,2 minutes and there after every 2 minutes for the first 15minutes. Then after every 5minutes till the end of surgery. 0 minute is defined as the time of removal of spinal needle. Surgery will be proceeded and after the delivery of the baby 20 international units of oxytocin intravenously will be administered. Delivery time , weight and apgar score of the baby will be noted. Hypotension is defined as 20% decrease in blood pressure from the baseline or systolic blood pressure less than 90mmhg. Bradycardia is defined as 20% decrease in heart rate from baseline or less than 50 beats/minute. Hypotension will be treated with intravenous ephedrine 6mg bolus dose and total dose required will be noted. Bradycardia will be treated with intravenous atropine 0.6mg and will be noted. Incidence of dizziness, nausea and vomiting due to maternal hypotension will also be noted. At the end of surgery blood loss and total intravenous crystalloids used will be noted. All patients will receive 2 mcg/kg of intravenous fentanyl after the delivery of the baby and intravenous paracetamol1g during skin closure. Patients who require more than three attempts for spinal anaesthesia and patients with insufficient sensory blockade at the end of 10mins, general anaesthesia will be administered and patients will be excluded from the study.By using the ultrasound ,the space cannot be identified,then the patient will be excluded from the study. |