| CTRI Number |
CTRI/2018/05/014252 [Registered on: 30/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
29/05/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparison of Ropivacaine and bupivacaine for injection into the lower back for doing endoscopic urological surgeries |
|
Scientific Title of Study
|
Intrathecal ropivacaine vs bupivacaine in endoscopic urological surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abhishek Rao Kordcal |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Anaesthesia,
Kasturba Medical College,
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
08202922288 |
| Fax |
|
| Email |
kordcal85@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
VT Kalyanappagol |
| Designation |
Professor |
| Affiliation |
Sri BM Patil Medical College |
| Address |
Department of Anaesthesia,
Sri BM Patil Medical College,
Bijapur
Bijapur
KARNATAKA
586101
India |
| Phone |
9844095250 |
| Fax |
|
| Email |
drvijay8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shiyad M |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Anaesthesia,
Kasturba Medical College,
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
shiyad82@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri BM patil Medical college,Department of Anaesthesia,Bijapur
|
|
|
Primary Sponsor
|
| Name |
Sri BM patil Medical college |
| Address |
Department of Anaesthesia,
Bijapur |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Abhishek Rao Kordcal |
Sri BM patil Medical college |
Department of Anaesthesia
Bijapur
Udupi
KARNATAKA |
09886118906
kordcal85@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shri BM Patil Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients posted for elective urological surgeries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group 1 |
Group 1 patients received 3mL of 0.5% hyperbaric bupivacaine intrathecally |
| Comparator Agent |
Group 2 |
Group 2 patients received 2mL of 0.75% isobaric ropivacaine intrathecally. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1, 2& 3 scheduled for urological surgery under spinal anaesthesia |
|
| ExclusionCriteria |
| Details |
1.Patients with contraindication to spinal anaesthesia
2.patient with history of allergy to amide local anaesthetics |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Onset of sensory block, onset and duration of motor block, highest level of sensory block |
After intrathecal injection of drug to end of procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of anaesthesia and muscle relaxation, haemodynamic parameters and adverse effects if any were studied |
After intrathecal injection of drug to end of procedure |
|
|
Target Sample Size
|
Total Sample Size="142"
Sample Size from India="142"
Final Enrollment numbers achieved (Total)= "142"
Final Enrollment numbers achieved (India)="142" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/12/2011 |
| Date of Study Completion (India) |
01/03/2013 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="10"
Days="20" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil publication till date |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The aim of our study is to compare the clinical effect of 0.75% intrathecal isobaric ropivacaine with 0.5% intrathecal hyperbaric bupivacaine. Group 1 patients received 3 ml of hyperbaric bupivacaine and Group 2 patients received 2 ml of 0.75% isobaric ropivacaine. Both the groups were compared for onset of sensory block, onset and duration of motor block, highest level of sensory block. There was no significant diffrence between the two groups in mean time to onset of sensory block at T10, 5.79+/- 1.38 minute with ropivacaine and 5.68+/-1.57 minute with bupivacaine. Highest level of sensory block attained was T6 in both groups. From the study we concluded that 2ml 0.75% ropivacaine provided comparable quality of sensory block but had slower onset and significantly shorter duration compared to 3ml 0.5% bupivacaine |