| CTRI Number |
CTRI/2022/08/044660 [Registered on: 05/08/2022] Trial Registered Prospectively |
| Last Modified On: |
04/08/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative study between spinal drug ropivacaine versus bupivacaine in planed surgery under spinal anaesthesia |
|
Scientific Title of Study
|
A Comparative evaluation of intrathecal hyperbaric ropivacaine versus hyperbaric bupivacaine in elective surgery under spinal anaesthesia
|
| Trial Acronym |
No |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ankita Patel |
| Designation |
Assistant Professor |
| Affiliation |
GCS Medical College hospital and reserach centre |
| Address |
Department of anaesthesia GCS Medical College hospital and research centre Ahmedabad
Department of anaesthesia GCS Medical College hospital and research centre Ahmedabad 380025
Ahmadabad
GUJARAT
380025
India |
| Phone |
9712981484 |
| Fax |
|
| Email |
drankitapatel30@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ankita Patel |
| Designation |
Assistant Professor |
| Affiliation |
GCS Medical College hospital and reserach centre |
| Address |
Department of anaesthesia GCS Medical College hospital and research centre Ahmedabad
Department of anaesthesia GCS Medical College hospital and research centre Ahmedabad 380025
Ahmadabad
GUJARAT
380025
India |
| Phone |
9712981484 |
| Fax |
|
| Email |
drankitapatel30@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ankita Patel |
| Designation |
Assistant Professor |
| Affiliation |
GCS Medical College hospital and reserach centre |
| Address |
Department of anaesthesia GCS Medical College hospital and research centre Ahmedabad
Department of anaesthesia GCS Medical College hospital and research centre Ahmedabad 380025
Ahmadabad
GUJARAT
380025
India |
| Phone |
9712981484 |
| Fax |
|
| Email |
drankitapatel30@gmail.com |
|
|
Source of Monetary or Material Support
|
| GCS Medical college hospital and Research centre Ahmedabad 380025 Gujarat |
|
|
Primary Sponsor
|
| Name |
GCS Medical College hospital and researah centre |
| Address |
GCS Medical College hospital and research centre Ahmedabad |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Ankita Patel |
GCS Medical College hospital and research centre |
Department of Anaesthesia GCS Medical College hospital and research centre naroda road Ahmedabad GUJARAT
Ahmadabad
GUJARAT |
9712981484
drankitapatel30@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
intrathecal hyperbaric bupivacaine |
After giving spinal anaesthesia with Hyperbaric bupivacaine 3.5ml intrathecal, we have observe the onsent of motor and sensory block as well regression of motor and sensory block after 4hours |
| Intervention |
Intrathecal Hyperbaric Ropivacaine |
After giving spinal anaesthesia with Hyperbaric Ropivacaine 3.5 ml intrathecal route ,we have observe the onsent of motor and sensory block and regression after 4hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patient with informed consent
Age between 18 to 75 Years
BMI<30kg/m2
ASA I & II
Infra umbilical Surgery <3 hours
|
|
| ExclusionCriteria |
| Details |
Patient who will not give consent
BMI>30kg/m2
ASA III & IV
Contraindication to spinal anaesthesia
Known Allergy to Ropivacaine or any other local Anaesthetic Agent
Duration of Surgery > 3hours
Patients on chronic Anticoagulation or Antiplatelet drugs
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess between Ropivacaine and Bupivacaine which has less cardiac and neurological complication |
immediate after giving spinal anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the Hemodynamics parameters and the regression of motor and sensory effects between ropivacaine and bupivacaine |
After 4 hours of giving spinal anaesthesia |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
05/08/2022 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A Comparative Evaluation of Intrathecal
Hyperbaric
Ropivacaine
versus Hyperbaric
Bupivacaine in Elective Surgery Under
Spinal
Anaesthesia Aims and Objective :
To
compare the anaesthetic and analgesic efficacy of Intrathecal Hyperbaric Ropivacaine and Hyperbaric Bupivacaine in patients posted for surgeries under
spinal anaesthesia. Primary objective is to
evaluate the efficacy
and safety of hyperbaric
Ropivacaine for
Neuraxial blockade compared to hyperbaric Bupivacaine and the secondary objective is to
compare the relative advantages and disadvantages of both the drugs, onset and
duration of anaesthesia, perioperative hemodynamic and any adverse effects. Material and methods: •Prospective
Randomized
Controlled
Study •Total
= 200 patients. ASA
grade I and II are
randomly
selected for the study and divided
into two groups of 100
each. •Two
groups
Group B - receive
3.5 ml of
0.5% hyperbaric bupivacaine intrathecally. •Group
R - receive 3.5 ml of 0.75% hyperbaric ropivacaine intrathecally.
•Onset
and extent of sensory block, onset and duration of motor block, the maximum height
of sensory block, and duration of analgesia, hemodynamic parameters and adverse
effects if any are studied. conclusion: Ropivacaine
has less cardio toxicity and neurotoxicity than Bupivacaine |