| CTRI Number |
CTRI/2023/06/053362 [Registered on: 01/06/2023] Trial Registered Prospectively |
| Last Modified On: |
31/05/2023 |
| 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 efficacy of injection of Ropivacaine plus Fentanyl and Ropivacaine plus Tramadol in spinal anaesthesia |
|
Scientific Title of Study
|
A clinical prospective, double blinded randomized controlled study to compare Intrathecal Hyperbaric Ropivacaine Hydrochloride 0.75%(3ml) plus Fentanyl with Intrathecal Hyperbaric Ropivacaine Hydrochloride0.75%(3ml) plus Tramadol for infraumbilical surgeries. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manikrindi Noorjahan |
| Designation |
PG Resident(dep of anaesthesia) |
| Affiliation |
Pacific medical college and hospital |
| Address |
Pacific medical college and hospital Department of Anaesthesiology Bhillon ka bedla Udaipur Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
9705235399 |
| Fax |
|
| Email |
noorjahansharif09@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prakash chandra audichya |
| Designation |
Professor and head of department |
| Affiliation |
Pacific medical college and hospital |
| Address |
Pacific medical college and hospital Department of Anaesthesiology Bhillon ka bedla Udaipur Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
9929721889 |
| Fax |
|
| Email |
Prakash.audichya10@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Manikrindi Noorjahan |
| Designation |
PG Resident |
| Affiliation |
Pacific medical college and hospital udaipur |
| Address |
Pacific medical college and hospital Department of Anaesthesiology Bhillon ka bedla Udaipur Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
9705235399 |
| Fax |
|
| Email |
noorjahansharif09@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pacific medical college and hospital,department of anaesthesia,bhillon ka bedla ,udaipur,rajasthan ,313001 |
|
|
Primary Sponsor
|
| Name |
Pacific medical college and hospital |
| Address |
flat no.404, building no P-4, Pacific mdical college and hopital, bhillon ki bedla,udaipur |
| Type of Sponsor |
Private 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 |
| DrPrakash chandra audichya department of anaesthesiology |
pacific medical college and hospital ,udaipur |
pacific medical college and hospital,department of anaesthesiology,bhillon ka bedla,udaipur,rajasthan,313001
Udaipur
RAJASTHAN |
9929721889
prakash.audichya10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, (2) ICD-10 Condition: K353||Acute appendicitis with localizedperitonitis, (3) ICD-10 Condition: N211||Calculus in urethra, (4) ICD-10 Condition: N701||Chronic salpingitis and oophoritis, , (5) ICD-10 Condition: S720||Fracture of head and neck of femur, (6) ICD-10 Condition: S828||Other fractures of lower leg, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Injection fentanyl 0.5ml (25mcg) |
Injection ropivacaine 0.75%3ml plus injection fentanyl 0.5ml(25mcg) intrathecally in infra umbilical surgeries |
| Intervention |
injection ropivacaine ,injection fentanyl ,injection tramadol |
Injection ropivcaine hydrochloride0.75%3ml with injection fentanyl 0.5ml and 0.5ml tramadol intrathecally in infraumbilical surgeries |
| Intervention |
Injection tramadol0.5ml (25mg) |
Injection ropivacaine 0.75%3ml plus injection tramadol 0.5ml (25mg) intrathecally in infraumbilical surgeries |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 All patients of age group between 20 and 60 years of either sex.
2 Patients belonging to American Society of Anaesthesiologists (ASA ) grade I and grade II.
3 Patients posted for infraumbilical surgeries.
|
|
| ExclusionCriteria |
| Details |
1.ASA Grade ≥III
2.Mental retardation (congenital anomaly) patients
3.Those with bleeding disorders and local sepsis,
4.Those on anti-coagulants and anti-platelet agents,
5.Those allergic to local anesthetic,
6.Patient refusal for the procedure and technical difficulties
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Duration of analgesia
Post operative analgesic requirement.
incidence of shivering.
Side effects if any like Pruritus, Hypotension, Bradycardia,Shivering
|
24months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration of analgesia & requirement of rescue analgesia |
24months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 4 |
|
Date of First Enrollment (India)
|
10/06/2023 |
| 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="2"
Months="0"
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
|
study to compare efficacy duration of analgesia onset and duration of sensory and motor block and hemodynamic stability of injection ropivacaine0.75%3ml with fentanyl 0.5mland tramadol 0.5ml intrathecally in infraumbilical surgeries |