CTRI

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CTRI Number

CTRI/2023/06/053746 [Registered on: 12/06/2023] Trial Registered Prospectively

Last Modified On:

06/07/2023

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Surgical/Anesthesia

Study Design

Randomized, Parallel Group Trial

Public Title of Study

Comparison of two drugs bupivacaine and ropivacaine given in spinal anesthesia in patients undergoing surgery vaginal hysterectomy.

Scientific Title of Study

A prospective study comparing hyperbaric Bupivacaine and hyperbaric Ropivacaine in patients undergoing elective vaginal hysterectomy under subarachnoid blockade.

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

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

Name	Ishita Katna
Designation	Junior Resident
Affiliation	Dr Rajendra Prasad Govt Medical College Kangra at Tanda
Address	Department of Anesthesia Dr RPGMC Kangra at Tanda Pin 176001 same as address 1 Kangra HIMACHAL PRADESH 176001 India
Phone	9805292604
Fax
Email	ikatna646@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Shyam Bhandari
Designation	Associate Professor
Affiliation	Dr Rajendra Prasad Govt Medical College
Address	Department of Anaesthesia Dr RPGMC Kangra at Tanda Pin 176001 Kangra HIMACHAL PRADESH 176001 India
Phone	9805135129
Fax
Email	dr.bhandari@yahoo.co.in

Details of Contact Person
Public Query

Name	Ishita Katna
Designation	Junior Resident
Affiliation	Dr Rajendra Prasad Govt Medical College at Tanda
Address	Department of Anaesthesia Dr RPGMC Kangra at Tanda Pin 176001 same as address 1 Kangra HIMACHAL PRADESH 176001 India
Phone	9805292604
Fax
Email	ikatna646@gmail.com

Source of Monetary or Material Support

Primary Sponsor

Name	Dr RPGMC Kangra
Address	Department of Anaesthesia Dr RPGMC Kangra at Tanda Pin 176001
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
Ishita Katna	Dr RPGMC Kangra at Tanda (H.P.)	Department of Anesthesiology Dr RPGMC Tanda Kangra (H.P.) Kangra HIMACHAL PRADESH	9805292604 ikatna646@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
DR RAJENDRA PRASAD GOVERNMENT MEDICAL COLLEGE KANGRA AT TANDA, Himachal Pradesh, India -176001	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: N72\|\|Inflammatory disease of cervix uteri,

Intervention / Comparator Agent
Modification(s)

Type	Name	Details
Comparator Agent	Ropivacaine 0.75% heavy	3ml of Bupivacaine 0.5% heavy is compared with 3ml Ropivacaine 0.75% heavy under subarachnoid blockade .Duration of surgery is 120 min.
Comparator Agent	Bupivacaine 0.5% heavy	3ml of Bupivacaine 0.5% heavy is compared with 3ml Ropivacaine 0.75% heavy under subarachnoid blockade .Duration of surgery is 120 min.

Inclusion Criteria

Age From	35.00 Year(s)
Age To	65.00 Year(s)
Gender	Female
Details	ASA 1 & 2 BMI (18-29.9) UNDERGOING ELECTIVE VAGINAL HYSTERECTOMY WITH AN ANTICIPATED DURATION OF 120 MINUTES

ExclusionCriteria

Details

REFUSAL TO PARTICIPATE IN STUDY
ALLERGY TO STUDY DRUG
OBESITY (BMI>30)
HEIGHT <150CM OR >180CM
PATIENTS IN WHICH SPACE OTHER THAN L3-L4 WAS USED FOR SUBARACHNOID BLOCK
PATIENTS WITH ABSOLUTE CONTRAINDICATIONS TO SPINAL ANAESTHESIA

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Participant, Investigator and Outcome Assessor Blinded

Primary Outcome

Outcome

TimePoints

To compare the block characteristics among two groups (sensory, motor and duration of analgesia
To study hemodynamic parameters among two groups(PR, SBP, DBP, MAP)

Time of injection of spinal drug(0 min)
Time of onset of sensory block(T12)
Time to achieve peak sensory block
Peak sensory level
Max sensory level after 20 min
Two segment regression time
Duration of sensory block
Total duration of analgesia
Onset of motor block (MBS 1)
Time to achieve complete motor block (MBS 3)
Max bromage score achieved
Duration of motor block
Hemodynamic variables at 5 min interval initially and then 15 min interval til the end of surgery

Secondary Outcome

Outcome	TimePoints
Any adverse events (hypotension, bradycardia, nausea and vomiting)	Total duration of surgery Any side effect

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)

18/06/2023

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="6"
Days="30"

Recruitment Status of Trial (Global)

Not Yet Recruiting

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

Spinal anesthesia is a very old and popular technique. It is a safe and effective form of regional anesthesia that can be used as an alternative to general anesthesia in surgery. Vaginal hysterectomy is one such lower abdominal surgery which commonly involves the use of spinal anesthesia. Thus, in order to further improve and understand the safety issues as well as clinical use of spinal anesthesia in vaginal hysterectomies, new local anesthetics are being investigated for different applications.

Ropivacaine is relatively new aminoamide local anesthetic agent similar in chemical structure to Bupivacaine and has been little studied in that application. Early evaluation of the drug included few studies which stated cardiotoxicity and CNS toxicity of Ropivacaine is less as compared to Bupivacaine. But the potency of Ropivacaine is less than Bupivacaine therefore its duration and intensity will also be proportionately less as experimented in lower limb surgeries.

Considering that relatively few studies have been conducted to compare the potency and toxicity of hyperbaric Ropivacaine with hyperbaric Bupivacaine in lower abdominal surgeries, we planned to conduct a study comprising Ropivacaine 0.75% hyperbaric with Bupivacaine 0.5% hyperbaric in patients undergoing vaginal hysterectomy under subarachnoid blockade.