CTRI

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CTRI Number

CTRI/2024/06/068901 [Registered on: 13/06/2024] Trial Registered Prospectively

Last Modified On:

12/06/2024

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Medical Device
Surgical/Anesthesia

Study Design

Other

Public Title of Study

Effects of Morphine in cesarean sections when used with hyperbaric bupivacaine and levobupivacaine.

Scientific Title of Study

Comparison of effect of morphine as an adjuvant to hyperbaric bupivacaine and hyperbaric levobupivacaine in elective cesarean sections

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 Angan Ghosh
Designation	Junior Resident
Affiliation	Datta Meghe Institute of higher education and research Centre
Address	Department of Anaesthesia AVBRH Sawangi Wardha Wardha MAHARASHTRA 442004 India
Phone	8826897423
Fax
Email	angan.ghosh05@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Sanjot Ninave
Designation	Professor
Affiliation	Datta Meghe Institute of higher education and research Centre
Address	Department of Anaesthesia AVBRH Sawangi Wardha Wardha MAHARASHTRA 442004 India
Phone	9921213404
Fax
Email	drsusann02@rediffmail.com

Details of Contact Person
Public Query

Name	Dr Angan Ghosh
Designation	Junior Resident
Affiliation	Datta Meghe Institute of higher education and research Centre
Address	Department of Anaesthesia AVBRH Sawangi Wardha Wardha MAHARASHTRA 442004 India
Phone	8826897423
Fax
Email	angan.ghosh05@gmail.com

Source of Monetary or Material Support

Datta Meghe Institute of higher education and research Centre,Sawangi,Wardha-442004

Primary Sponsor

Name	Datta Meghe Institute of higher education and research Centre
Address	Datta Meghe Institute of higher education and research Centre,Sawangi,Wardha,Maharashtra,442004
Type of Sponsor	Private 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
Dr Angan Ghosh	Acharya Vinoba Bhave rural Hospital	Department of Anaesthesia Wardha MAHARASHTRA	8826897423 angan.ghosh05@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional ethics committee,DMIHER(DU)	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: O\|\|Medical and Surgical,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Effect of adding morphine as an adjuvant to hyperbaric bupivacaine in elective cesarean sections	The patient will receive hyperbaric Inj Bupivacaine 0.5% 10 mg (1.9 ml) + Inj Morphine 100 microgram (0.1 ml) ,( Total volume- 2 ml).Duration-3 hours
Comparator Agent	Effect of adding morphine as an adjuvant to hyperbaric levobupivacaine in elective cesarean sections	The patient will receive hyperbaric Inj Levobupivacaine 0.5% 10 mg (1.9 ml) + Inj Morphine 100 microgram (0.1 ml) , ( Total volume-2 ml).Duration-3 hours

Inclusion Criteria

Age From	18.00 Year(s)
Age To	35.00 Year(s)
Gender	Female
Details	1.Female in the age group of 18-35 years. 2.Patient undergoing elective cesarean section. 3.Duration of Surgery 1-2 hours . 4.ASA 1 and 2 5.MPC 1 and 2 5.Weight of the patient more than equal to50 kilograms 8.Patients willing to participate in the study 9.Patient fulfilling criteria for Subarachnoid Block

ExclusionCriteria

Details

1.Lack of valid informed written consent
2.ASA grade 3 and 4
3.Weight of the patient less than equal to 50 kilograms
4.Infection at the Subarachnoid Block site
5.Patients with neurological and musculoskeletal disease
6.Patients with bleeding disorders
7.Patients on anticoagulants
8.History of allergy to local anaesthetic and injection Fentanyl.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Alternation

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
To compare the hemodynamic and analgesic effects of morphine as an adjuvant to bupivacaine and levobupivacaine in patients undergoing elective cesarean section.	1 hours

Secondary Outcome

Outcome	TimePoints
1.Time to onset of sensory block and maximum level of sensory block reached. 2.The level of motor block . 3.Time to regression of two dermatomes of sensory block. 4.Duration of regression of sensory block level to T11 from maximum level . . 5.First rescue analgesia asked by patient ( VAS SCORE) 6.Neonatal outcomes (APGAR SCORE) 7.Any side effects.	3 hours

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 2

Date of First Enrollment (India)

30/06/2024

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="0"
Months="6"
Days="0"

Recruitment Status of Trial (Global)

Not Yet Recruiting

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

Purpose of the trial is to compare the effects of morphine as an adjuvant to hyperbaric bupivacaine and hyperbaric levobupivacaine in elective cesarean sections

Morphine as an adjuvant to hyperbaric levobupivacaine is more effective than hyperbaric bupivacaine for prolonged post operative analgesia,hemodynamic stability, shorter motor block and lesser side effects in elective cesarean sections.