| CTRI Number |
CTRI/2023/11/060021 [Registered on: 20/11/2023] Trial Registered Prospectively |
| Last Modified On: |
17/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparision of 2 drugs( hyperbaric bupivacaine and hyperbaric ropivacaine) used in spinal anaesthesia for caeserean section in patients with pregnancy induced hypertension
 |
|
Scientific Title of Study
|
Comparison of hyperbaric ropivacaine and hyperbaric bupivacaine for Spinal Anaesthesia in Pregnancy Induced Hypertension (PIH) parturients undergoing Caesarean Section - A randomized controlled 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 |
RAJESHKUMAR N |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Anaesthesiology and Critical care,
Jawaharlal Institute of Postgraduate Medical Education and Research,
Puducherry-605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9488997201 |
| Fax |
|
| Email |
drnrajeshkumar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr STALIN V |
| Designation |
Additional Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Anaesthesiology and Critical Care, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry-605006.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9786397762 |
| Fax |
|
| Email |
drvstalin@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr STALIN V |
| Designation |
Additional Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Anaesthesiology and Critical Care, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry-605006.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9786397762 |
| Fax |
|
| Email |
drvstalin@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Postgraduate Medical Education and Research, Gorimedu,
Dhanvantari Nagar,
Puducherry-605006. |
|
|
Primary Sponsor
|
| Name |
RAJESHKUMAR N |
| Address |
Junior Resident,
Department of Anaesthesiology and Critical care,
JIPMER,
Puducherry-605006.
|
| Type of Sponsor |
Other [self] |
|
|
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 RAJESHKUMAR N |
Jawaharlal Institute of Postgraduate Medical Education and Research |
Institute Block,2nd floor, Department of Anaesthesiology and critical care.
Pondicherry
PONDICHERRY |
9488997201
drnrajeshkumar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE INTERVENTIONAL STUDIES CDSCO Reg. No. ECR/342/Inst/PY/2013/RR-19 |
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 |
Hyperbaric Bupivacaine |
Injection of 0.5% Hyperbaric Bupivacaine, 1.8 ml, during spinal anaesthesia, from injection of drug until the patient is shifted to recovery room and starts ambulation, duration 5 hours |
| Intervention |
Hyperbaric Ropivacaine |
Injection of 0.75% Hyperbaric Ropivacaine, 1.8 ml, during spinal anaesthesia, from injection of drug until the patient is shifted to recovery room and starts ambulation, duration 5 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
34.00 Year(s) |
| Gender |
Female |
| Details |
Hypertensive disorders of pregnancy planned for elective caesarean section under Spinal Anaesthesia |
|
| ExclusionCriteria |
| Details |
Hypersensitivity to any of the study drugs,
Patients with spinal deformity,
Patients with coagulopathy,
Short stature (less than 140 cms),
Elderly primigravida,
Precious pregnancy,
Other comorbidities like Diabetes Mellitus, CAD, Congenital heart diseases, Valvular heart diseases etc. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the incidence of hypotension with Inj. 0.75% Hyperbaric Ropivacaine as compared to Inj. 0.5% Hyperbaric Bupivacaine during Spinal Anaesthesia for Caesarean Section in PIH |
Untill patient is shifted to recovery room |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To compare the onset and regression of sensory block up to T10 between 2 groups.
2)To compare the onset and regression of motor block between 2 groups.
3)To compare incidence of side effects between 2 groups. |
untill regression of sensory block and motor block in recovery room |
|
|
Target Sample Size
|
Total Sample Size="146"
Sample Size from India="146"
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)
|
25/11/2023 |
| 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="8"
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 or sub-arachnoid block (SAB), is commonly employed for caesarean sections. It is associated with various complications like hypotension and delayed ambulation. Presently Inj.0.5% hyperbaric bupivacaine is the most widely used drug for spinal anaesthesia. Though Inj. Hyperbaric Bupivacaine is widely used and very effective in Spinal Anaesthesia, it has the propensity to cause adverse hemodynamic effects. It is more lipophilic causing both sensory and motor blockade for prolonged duration. In today’s world, where minimal side effects and early ambulation are the demands of the hour, studies done with 0.5% ropivacaine made hyperbaric by addition of 25% dextrose have found it to be an alternative for Inj. Hyperbaric bupivacaine causing less cardiac side effects and providing early ambulation due to its sensorimotor dissociation and early regression. Literature search shows studies have so far been done with prepared hyperbaric ropivacaine by anaesthesiologist under aseptic conditions. Commercially available Inj. 0.75% Hyperbaric Ropivacaine has been recently introduced in India and it has not been studied in PIH parturients. Commercially available Inj. 0.75% Hyperbaric Ropivacaine provides reliable Spinal Anaesthesia as Inj. Hyperbaric Bupivacaine. Based on the results of the study, Inj. 0.75% Hyperbaric Ropivacaine can be a safer alternative to Inj.0.5% hyperbaric Bupivacaine in providing better hemodynamic profile and early ambulation. |