CTRI

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CTRI Number

CTRI/2023/06/054563 [Registered on: 30/06/2023] Trial Registered Prospectively

Last Modified On:

07/08/2024

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Surgical/Anesthesia

Study Design

Randomized, Parallel Group Trial

Public Title of Study

Comparative study of the efficacy and safety of intrathecal hyperbaric ropivacaine with hyperbaric bupivacaine in patients undergoing caesarean section under spinal anaesthesia

Scientific Title of Study

Comparative evaluation of the efficacy and safty of intrathecal hyperbaric ropivacaine with hyperbaric bupivacaine in patients undergoing caesarean section under spinal anaesthesia

Trial Acronym

Not applicable

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr SK Singhal
Designation	Senior Professor and Head
Affiliation	Pt B.D. Sharma PGIMS, Rohtak Haryana
Address	Department of anaesthesiology and critical care,Pt B.D. Sharma PGIMS, Rohtak Haryana 124001 India Department of anaesthesiology and critical care,Pt B.D. Sharma PGIMS, Rohtak Haryana 124001 India Rohtak HARYANA 124001 India
Phone	9416391115
Fax
Email	ssinghal12@gmail.com

Details of Contact Person
Scientific Query

Name	Dr SK Singhal
Designation	Senior Professor and Head
Affiliation	Pt B.D. Sharma PGIMS, Rohtak Haryana
Address	Department of anaesthesiology and critical care,Pt B.D. Sharma PGIMS, Rohtak Haryana 124001 India Department of anaesthesiology and critical care,Pt B.D. Sharma PGIMS, Rohtak Haryana 124001 India HARYANA 124001 India
Phone	9416391115
Fax
Email	ssinghal12@gmail.com

Details of Contact Person
Public Query

Name	Dr SK Singhal
Designation	Senior Professor and Head
Affiliation	Pt B.D. Sharma PGIMS, Rohtak Haryana
Address	Department of anaesthesiology and critical care,Pt B.D. Sharma PGIMS, Rohtak Haryana 124001 India Department of anaesthesiology and critical care,Pt B.D. Sharma PGIMS, Rohtak Haryana 124001 India Rohtak HARYANA 124001 India
Phone	9416391115
Fax
Email	ssinghal12@gmail.com

Source of Monetary or Material Support

Anaesthesia and critical care department, Pt. B.D.Sharma PGIMS, Rohtak

Primary Sponsor

Name	Pt B D Sharma University of Health Sciences PGIMS Rohtak Haryana
Address	Pt B D Sharma University of Health Sciences,PGIMS Rohtak Haryana 124001
Type of Sponsor	Government medical college

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Roopa Indora	Pt B.D. Sharma, PGIMS	Department of Anaesthesiology and critical care Pt B D Sharma University of Health Sciences, PGIMS Rohtak Haryana 124001 Rohtak HARYANA	9630730039 roopaindora12@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Biomedical Research Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: 1\|\|Obstetrics,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Under all aseptic precautions subarachnoid block will be performed at L3-L4 or L4-L5 interspace with patient in sitting position, using 2 ml of 0.5% hyperbaric bupivacaine	Spinal anaesthesia is given using 2ml of 0.5% hyperbaric bupivacaine Following variables will be recorded: Onset of sensory block at T10 dermatome Maximum level of sensory block achieved Time taken to achieve maximal level of sensory block Onset of motor block (bromage scale 1) Time to achieve complete motor block Duration of sensory block: from time of onset at T10 dermatome till regression to L5 Duration of analgesia: from the onset of sensory block at T10 till VAS score 4 (first request for analgesia). Duration of motor block: from time of onset till complete motor recovery. Heart rate and systolic blood pressure will be recorded at baseline, every 2 minutes during the first 10 minutes after spinal block, then every 5 minutes during the first hour and then every 10 minutes until the patient is shifted to the recovery room. Adverse effects like hypotension, bradycardia, nausea, vomiting, any episode of desaturation (spo2 90%), or arrhythmias.
Intervention	Under all aseptic precautions subarachnoid block will be performed at L3-L4 or L4-L5 interspace with patient in sitting position, using 2ml of 0.75% hyperbaric ropivacaine	Spinal anaesthesia is given using 2ml of 0.75% hyperbaric ropivacaine Following variables will be recorded: Onset of sensory block at T10 dermatome Maximum level of sensory block achieved Time taken to achieve maximal level of sensory block Onset of motor block (bromage scale 1) Time to achieve complete motor block Duration of sensory block: from time of onset at T10 dermatome till regression to L5 Duration of analgesia: from the onset of sensory block at T10 till VAS score 4 (first request for analgesia). Duration of motor block: from time of onset till complete motor recovery. Heart rate and systolic blood pressure will be recorded at baseline, every 2 minutes during the first 10 minutes after spinal block, then every 5 minutes during the first hour and then every 10 minutes until the patient is shifted to the recovery room. Adverse effects like hypotension, bradycardia, nausea, vomiting, any episode of desaturation (spo2 90%), or arrhythmias.

Inclusion Criteria

Age From	20.00 Year(s)
Age To	35.00 Year(s)
Gender	Female
Details	Parturients between 20 to 35 years of age (American Society of Anaesthesiologists, ASA II) undergoing caesarean section under spinal anaesthesia

ExclusionCriteria

Details

1 Patient refusal
2 <18 years
3 BMI > 35kg/m2
4 Height < 5 feet
5 Any contraindication to regional anesthesia
6 Twin pregnancy
7 Drug allergy to local anaesthetics/study drugs
8 Refusal to give consent
9 Conversion to general anesthesia

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Participant and Outcome Assessor Blinded

Primary Outcome

Outcome	TimePoints
To compare the two drugs in terms of Onset of sensory and motor block. Duration of sensory and motor block.	The segmental level of sensory block will be assessed by loss of sensation to pin-prick at 2 minute intervals for first 15 minutes and thereafter at 15 minute intervals till regression to L5. The motor block will be evaluated at similar time intervals using modified Bromage scale.

Secondary Outcome

Outcome	TimePoints
To compare the maximum level of sensory block achieved To compare the frequency of adverse effects like hypotension, bradycardia, nausea, vomiting in both the groups	Time taken to achieve maximal level of sensory block will be noted in both groups Adverse effects like hypotension, bradycardia, nausea, vomiting, arrythmias, any episode of desaturation(spo2 less than 90%)

Target Sample Size

Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90"

Phase of Trial

Phase 3/ Phase 4

Date of First Enrollment (India)

10/07/2023

Date of Study Completion (India)

01/03/2024

Date of First Enrollment (Global)

10/07/2023

Date of Study Completion (Global)

01/03/2024

Estimated Duration of Trial

Years="1"
Months="0"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Completed

Recruitment Status of Trial (India)

Completed

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

In this study we are comparing the efficacy and safety of intrathecal hyperbaric ropivacaine with hyperbaric bupivacaine in patients undergoing caesarean section under spinal anesthesia. The present study is intended to compare the efficacy and safety of hyperbaric ropivacaine with hyperbaric bupivacaine.