| CTRI Number |
CTRI/2024/12/078277 [Registered on: 18/12/2024] Trial Registered Prospectively |
| Last Modified On: |
17/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the effectiveness of
0.75 percent Ropivacaine heavy alone and 0.75 percent Ropivacaine heavy with fentanyl as an adjuvant in spinal anaesthesia for infra umbilical surgeries |
|
Scientific Title of Study
|
A study to compare the effects of 0.75 percent [H] Ropivacaine alone v/s 0.75 percent [H] Ropivacaine with fentanyl as an adjuvant in spinal anaesthesia for infra umbilical surgeries |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shirin Jain |
| Designation |
Resident Doctor |
| Affiliation |
Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Anesthesia department, General Ot Complex , 1st Floor , Dhiraj Hospital , Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre , Waghodia , Piparia , Vadodara
GUJARAT
Vadodara
GUJARAT
391760
India |
| Phone |
9727700998 |
| Fax |
|
| Email |
shirinjain96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dinesh k Chauhan |
| Designation |
Medical Superintendent and Professor Of Department |
| Affiliation |
Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Anesthesia department, General Ot Complex , 1st Floor , Dhiraj Hospital , Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre , Waghodia , Piparia , Vadodara
GUJARAT
Vadodara
GUJARAT
391760
India |
| Phone |
9099014672 |
| Fax |
|
| Email |
drdinesh77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dinesh k Chauhan |
| Designation |
Medical Superintendent and Professor Of Department |
| Affiliation |
Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Anesthesia department, General Ot Complex , 1st Floor , Dhiraj Hospital , Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre , Waghodia , Piparia , Vadodara
GUJARAT
Vadodara
GUJARAT
391760
India |
| Phone |
9099014672 |
| Fax |
|
| Email |
drdinesh77@gmail.com |
|
|
Source of Monetary or Material Support
|
| Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre , Waghodia , Piparia , Vadodara , Gujarat , Pincode -391760 |
|
|
Primary Sponsor
|
| Name |
Smt. Bhikiben Kanjibhai Shah medical Institute and Research Centre |
| Address |
Waghodia, Piparia , Vadodara , Gujarat , Pincode -391760 |
| 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 |
| Dr Dinesh K Chauhan |
Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
Anesthesia department, General Ot Complex , 1st Floor , Dhiraj Hospital , Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre , Waghodia , Piparia , Vadodara
GUJARAT
Vadodara
GUJARAT |
9099014672
drdinesh77@gamil.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SUMANDEEP VIDYAPEETH INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hyperbaric Ropivacaine |
Dose: 0.75% Hyperbaric Ropivacaine 2.5ml with 0.5ml normal saline total 3ml
Route of administration: intrathecal administration
Total duration: 4.5 hours from intrathecal administration. |
| Comparator Agent |
Hyperbaric Ropivacaine and Fentanyl |
Dose: 0.75% Hyperbaric Ropivacaine 2.5ml with fentanyl 0.5ml (25mcg) total 3 ml
Route of administration: intrathecal administration
Total duration: 6 hours from intrathecal administration. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient willing to sign the written and informed consent
2.Patient belonging to ASA 1 ,2 and 3
3.Patient posted for elective infra umblical surgeries |
|
| ExclusionCriteria |
| Details |
1.Patient refusal
2.Patient with coagulation disorder or an anticoagulant therapy
3.Local infection at the site of proposed puncture for spinal anesthesia , spinal deformities
4.Known allergy to study drugs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to compare the efficacy of intrathecal fentanyl as an adjuvant to hyperbaric 0.75% ropivacaine and hyperbaric 0.75% ropivacaine alone in prolonging effects of spinal and motor block ,hemodynamic stability, effect on duration of anaesthesia and post operative analesgia in patients receiving spinal anaesthesia in infra umbilical surgeries |
Baseline
0 minutes
2 minutes
5 minutes
10 minutes
20 minutes
30 minutes
45 minutes
60 minutes
75 minutes
90 minutes
105 minutes
120 minutes
135 minutes
150 minutes
165 minutes
180 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Assess VAS Score , Duration of Absolute & effective analgesia, number of rescue analgesia required in 24 hrs & post operative complication if any |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
30/12/2024 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
the purpose of the study is to compare the effects of administration of intrathecal fentanyl as an adjuvant to intrathecal ropivacaine 0.75% versus administration only intrathecal ropivacaine 0.75% for prolonging the effect of spinal and motor block in spinal anesthesia , hemodynamic stability , effect on duration of anesthesia , effects on duration of analgesia and side effects if occurs . |