CTRI

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CTRI Number

CTRI/2024/09/073241 [Registered on: 02/09/2024] Trial Registered Prospectively

Last Modified On:

22/03/2025

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Drug

Study Design

Randomized, Crossover Trial

Public Title of Study

Comparison of Isobaric versus Hyperbaric Levobupivacine for Laproscopic Cholecystectomy

Scientific Title of Study

Effectiveness and Safety of Segmental Thoracic Spinal Anaesthesia using Isobaric Levobupivacaine 0.5 percent versus Hyperbaric Levobupivacaine 0.5 percent in Laproscopic Cholecystectomy

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 Neha Mishra
Designation	Assistant Professor
Affiliation	GSVM MEDICAL COLLEGE, KANPUR
Address	Department of Anaesthesia Hellet Hospital, GSVM Sarvodhayanagar Kanpur 208005 Department of Anaesthesia Hellet Hospital, GSVM Sarvodhayanagar Kanpur 208005 Kanpur Nagar UTTAR PRADESH 208005 India
Phone	08874311115
Fax
Email	dr.nehamishra86@gmail.com

Details of Contact Person
Scientific Query

Name	dr Neha Mishra
Designation	Assistant Professor
Affiliation	GSVM MEDICAL COLLEGE, KANPUR
Address	Department of Anaesthesia Hellet Hospital, GSVM Sarvodhayanagar Kanpur 208005 Department of Anaesthesia Hellet Hospital, GSVM Sarvodhayanagar Kanpur 208005 Kanpur Nagar UTTAR PRADESH 208005 India
Phone	08874311115
Fax
Email	dr.nehamishra86@gmail.com

Details of Contact Person
Public Query

Name	dr Neha Mishra
Designation	Assistant Professor
Affiliation	GSVM MEDICAL COLLEGE, KANPUR
Address	Department of Anaesthesia Hellet Hospital, GSVM sarvodhayanagar Kanpur 208005 Department of Anaesthesia Hellet Hospital, GSVM Sarvodhayanagar Kanpur 208005 UTTAR PRADESH 208005 India
Phone	08874311115
Fax
Email	dr.nehamishra86@gmail.com

Source of Monetary or Material Support

Department of Anaesthesia Hellet Hospital, GSVM Kanpur 208005

Primary Sponsor

Name	GSVM
Address	Department of Anaesthesia Hellet Hospital,GSVM Sarvodhayanagar KANPUR 208005 INDIA
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
DR Neha Mishra	gsvm anaesthesia department	Department of Anaesthesia Hellet Hospital, GSVM Sarvodhayanagar Kanpur 208005 Kanpur Nagar UTTAR PRADESH	08874311115 dr.nehamishra86@gmail.com

Details of Ethics Committee
Modification(s)

No of Ethics Committees= 1
Name of Committee	Approval Status
GSVM	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, (2) ICD-10 Condition: 8\|\|Other Procedures,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	hyperbaric levobupivacaine 0.5 percent	ISOBARIC LEVOBUPIVACAINE 0.5 PERCENT VERSUS HYPERBARIC LEVOBUPIVACAINE 0.5 PERCENT IS COMPARED
Intervention	ISOBARIC LEVOBUPIVACAINE 0.5 PERCENT	ISOBARIC LEVOBUPIVACAINE 0.5 PERCENT VERSUS HYPERBARIC LEVOBUPIVACAINE 0.5 PERCENT IS COMPARED

Inclusion Criteria

Age From	18.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	1) Informed written consent 2) Age: 18- 60 yrs 3) American society of anaestheslogist (ASA) I and II 4) Elective surgery 5) Duration of surgery not exceeding 90 min

ExclusionCriteria

Details

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Not Applicable

Blinding/Masking

Participant and Outcome Assessor Blinded

Primary Outcome

Outcome	TimePoints
Efficacy of Sensory and Motor Block	Onset and Duration of sensory block Onset and Duration of motor block

Secondary Outcome

Outcome	TimePoints
Hemodynamic Variables Adverse effects	Heartrate,Systolic blood pressure,Diasytolic blood pressure,Mean blood pressure,Saturation

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

N/A

Date of First Enrollment (India)

14/09/2024

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="3"
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

Laparoscopic procedures like lap cholecystectomy has become a day care procedure due to advancement in surgical as well as anaesthesia technique.To compare isobaric levobupivacaine 0.5 % with hyperbaric levobupivacaine 0.5% in segmental thoracic spinal anaesthesia in laparoscopic cholecystectomy:- Primary aim: Effective sensory block ( onset and duration),Effective motor block ( onset and duration), Hemodynamic stability AND Secondary aim Adverse effects if any( incidence of shoulder pain). 30 patients will be selected randomly for laparoscopic cholecystectomy in group A and group B. Written informed consent to be taken. consent to be taken regarding discomfort, pain during surgery, immediate intervention will be done( general anaesthesia may be supplemented).

Technique:

a) After securing intravenous line and standard ASA monitoring, premedication given.

b) Painting and draping done adequately.

c) Locate T10-T11 interspace after identifying T7 corresponding to inferior angle of scapula. After giving local anaesthesia , spinal anaethesia given with 25 G quinke needle after confirmation of CSF.

d) No tilting of table will be done.