| CTRI Number |
CTRI/2018/05/014012 [Registered on: 21/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
15/05/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparation of spinal Levobupivacaine With Fentanyl And Ropivacaine With Fentanyl For Lower Abdominal And Lower Limb Surgery |
|
Scientific Title of Study
|
A Comparative Study Of Equipotent Doses Of Intrathecal Levobupivacaine With Fentanyl And Ropivacaine With Fentanyl For Lower Abdominal And Lower Extremity Surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pramila Soni |
| Designation |
senior resident |
| Affiliation |
St. Stephens Hospital, delhi |
| Address |
flat no. 203
2nd floor,jai laxmi apartment,
new bhupalpura, udaipur.
Udaipur
RAJASTHAN
313001
India |
| Phone |
8447923480 |
| Fax |
|
| Email |
drpramilasoni22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pramila Soni |
| Designation |
senior resident |
| Affiliation |
RNT MEDICAL COLLEGE, UDAIPUR |
| Address |
flat no. 203
2nd floor,jai laxmi apartment,
new bhupalpura, udaipur.
Udaipur
RAJASTHAN
313001
India |
| Phone |
8447923480 |
| Fax |
|
| Email |
drpramilasoni22@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Lalit mohan sharma |
| Designation |
Consultant Anaesthesiology |
| Affiliation |
National board of examination, delhi |
| Address |
Department of Anaesthesiology, st. Stephens Hospital, tis hazari, delhi
Central
DELHI
110054
India |
| Phone |
9602476506 |
| Fax |
|
| Email |
lmsharma421@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, St Stephens Hospital, tis hazari, delhi |
|
|
Primary Sponsor
|
| Name |
St Stephens hospital |
| Address |
St. Stephens hospital, tis hazari, delhi |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Pramila Soni |
St Stephens Hospital |
Department of Anaesthesiology
New Delhi
DELHI |
8447923480
drpramilasoni22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| St. Stephens Hospital ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Scheduled for lower Abdominal And Lower Extremity surgeries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Levobupivacaine |
Levobupivacaine 15mg with Fentanyl 25mcg given Intrathecally
|
| Comparator Agent |
Ropivacaine |
Ropivacaine 22.5mg with Fentanyl 25mcg given Intrathecally |
| Intervention |
Subarachnoid block |
Subarachnoid block given with either of the study drugs in L3 L4 space |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA CLASS 1 OR 2
Duration of surgery < 120minutes
Body weight 30 to 80 kg |
|
| ExclusionCriteria |
| Details |
ASA CLASS 3 OR 4
Emergency surgery
Pregnancy
Contraindications to subarachnoid block |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Levobupivacaine + Fentanyl group-
Onset of sensory block was 2.9 min
Onset of motor block was 3mins
Duration of sensory block was 271.5 mins
Duration of motor block was 252.1 mins
Ropivacaine + Fentanyl group-
Onset of sensory block was 3.9mins
Onset of motor block was 5mins
Duration of sensory block was 228 mins
Duration of motor block was 195.3 mins |
For Onset 30min
For Duration 360min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Duration of analgesia-
Levobupivacaine group 292.8mins
Ropivacaine group 258 mins |
360 mins |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/01/2014 |
| Date of Study Completion (India) |
25/06/2015 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="5"
Days="25" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
We conducted a randomized Comparative study in 60 ASA 1 patients undergoing lower Abdominal or lower Extremity surgery, divided into 2 groups 30 of each, LF and RF. Group LF was given Intrathecal Levobupivacaine 15mg+ Fentanyl 25mcg. Group RF was given Intrathecal Ropivacaine 22.5mg+ Fentanyl 25mcg. We compared the onset and duration of sensory block as well as motor block, duration of analgesia, hemodynamic stability and side effects. We found that Levobupivacaine had faster onset as well as longer duration of both sensory and motor block and longer duration of analgesia also with comparable hemodynamics. So we recommend the use of Intrathecal Levobupivacaine combined with Fentanyl for lower Abdominal And Lower Extremity surgeries. |