| CTRI Number |
CTRI/2021/11/037980 [Registered on: 12/11/2021] Trial Registered Prospectively |
| Last Modified On: |
08/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Compare Anaesthetic Effect of intrathecal 1% 2-Chloroprocaine versus ropivacaine 0.5% with Fentanyl in Urological Surgeries. |
|
Scientific Title of Study
|
Comparison Of Anaesthetic Effect of intrathecal 1% 2-Chloroprocaine versus ropivacaine 0.5% with Fentanyl in urological surgeries:A Randomized double blind, interventional study, SMS Medical College and Attached group of Hospitals,Jaipur during 2020-2021. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Varsha Kothari |
| Designation |
Senior Professor |
| Affiliation |
S.M.S. Medical College and Attached Group Of Hospitals |
| Address |
Department Of Anaesthesiology, S.M.S. Medical College and Attached Group Of Hospitals,
Adarsh Nagar,
Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9414870228 |
| Fax |
|
| Email |
vkothari66@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Varsha Kothari |
| Designation |
Senior Professor |
| Affiliation |
S.M.S. Medical College and Attached Group Of Hospitals |
| Address |
Department Of Anaesthesiology, S.M.S. Medical College and Attached Group Of Hospitals,
Adarsh Nagar,
Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9414870228 |
| Fax |
|
| Email |
vkothari66@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aayushi Dadhich |
| Designation |
Post Graduate Student |
| Affiliation |
S.M.S. Medical College and Attached Group Of Hospitals |
| Address |
Department Of Anaesthesiology, S.M.S. Medical College and Attached Group Of Hospitals,
Adarsh Nagar,
Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9414870228 |
| Fax |
|
| Email |
aayushidadhicha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, S.M.S. Medical College and Attached Group of Hospitals, Jaipur |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology SMS Medical College and Attached Group of Hospitals Jaipur |
| Address |
Adarsh Nagar, Jaipur. |
| Type of Sponsor |
Government medical college |
|
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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 Aayushi Dadhich |
S.M.S. Medical College and Attached group of Hospitals |
Adarsh Nagar, Jaipur.
Jaipur
RAJASTHAN |
9414870228
aayushidadhicha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| S.M.S. Medical College and Attached group of Hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N399||Disorder of urinary system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A |
30 patients will receive intrathecal 1% 2-chloroprocaine with fentanyl. |
| Comparator Agent |
Group B |
30 patients will receive intrathecal 0.5% ropivacaine with fentanyl. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients willing to give consent to participate in the study.
2.Patients posted for urological surgeries belonging to ASA grade I and II.
3.Age between 18 and 55 years.
4.Weight between 50 and 75 kg and height between 150 and 180 cms. |
|
| ExclusionCriteria |
| Details |
1.Patients with skin infection at local site.
2.Patients with severe hypovolemia, severe MS, blood coagulopathies.
3.Patients with raised intracranial pressure.
4.Patients allergic to drugs used for study.
5.Failure of spinal anaesthesia, cases in which general anaesthesia will be required. |
|
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Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the difference in mean onset time and duration of motor block in both groups. |
To compare the difference in mean onset time and duration of motor block in both groups. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare the in degree of motor and sensory block in both groups.
2.To determine difference in change in hemodynamic variables for baseline to 5,10,15,20 mins upto 4 hours post spinal period.
3. Adverse effects if any. |
Time taken from intrathecal injection to achieve highest level of sensory block and modified bromage score 1 to 4 hours post op to check complications if any. |
|
|
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)
|
20/11/2021 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Intrathecal chloroprocaine can be used as an alternative to long acting local anesthetics such as ropivacaine for urological surgeries requiring short duration and early ambulation with minimum side effects. As we observed in this study that the intrathecal 1% 2-chloroprocaine with fentanyl provides adequate motor blockade and analgesia for day care urological surgeries while 0.5 % ropivacaine with fentanyl provides a greater duration of sensory and motor blockade than chloroprocaine. Furthermore, fentanyl as an adjuvant to both ropivacaine and chloroprocaine enhances the duration of analgesia and stabilizes hemodynamic variables. |