| CTRI Number |
CTRI/2024/06/069299 [Registered on: 20/06/2024] Trial Registered Prospectively |
| Last Modified On: |
19/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Ropivacaine with Levobupivacaine for epidural analgesia in Lower limb orthopedic surgeries |
|
Scientific Title of Study
|
To evaluate the efficacy of epidural analgesia with Ropivacaine 0.2% and levobupivacaine 0.25% in lower limb orthopaedic 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 |
Dr. Samruddhi Dhamdhere |
| Designation |
PG Resident 1st year |
| Affiliation |
Smt Kashibai Navale Medical College and General Hospital, Pune |
| Address |
Operation theatre complex 1.Smt Kashibai Navale Medical College and General Hospital, Narhe, Pune 411041
Pune
MAHARASHTRA
411041
India |
| Phone |
7028190464 |
| Fax |
|
| Email |
drsamruddhi22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neha Panse |
| Designation |
Professor |
| Affiliation |
Smt Kashibai Navale Medical College and General Hospital, Pune |
| Address |
Department of Anesthesiology. Smt kashibai Navale Medical College Pune.
Operation Theatre complex, new building,Smt Kashibai Navale Medical College and General Hospital, Pune
Pune
MAHARASHTRA
411046
India |
| Phone |
9689495891 |
| Fax |
|
| Email |
drnehaghule@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neha Panse |
| Designation |
Professor |
| Affiliation |
Smt Kashibai Navale Medical College and General Hospital, Pune |
| Address |
Department of Anesthesiology, Smt kashibai Navale Medical College,Pune
Operation Theatre complex, new building,Smt Kashibai Navale Medical College and General Hospital, Pune
Pune
MAHARASHTRA
411046
India |
| Phone |
9689495891 |
| Fax |
|
| Email |
drnehaghule@gmail.com |
|
|
Source of Monetary or Material Support
|
| Smt Kashibai Navale Medical College and General Hospital, Narhe, Pune 411041 |
|
|
Primary Sponsor
|
| Name |
Samruddhi Dhamdhere |
| Address |
Operation theatre complex 1, Smt Kashibai Navale Medical College and General Hospital, Narhe, Pune 411041 |
| Type of Sponsor |
Other [Self] |
|
|
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 NEHA PANSE |
Kashibai Navale Medical College |
Operation Theatre Complex Theatre no.6,7,8
Pune
MAHARASHTRA |
9689495891
drnehaghule@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Smt. Kashibai Navale Medical College and General Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M800||Age-related osteoporosis with current pathological fracture, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
0.2% Ropivacaine |
0.2 % Ropivacaine at 0.2 mg/kg/hr given epiduraly postoperatively |
| Comparator Agent |
0.25% levobupivacaine |
0.25% Levobupivacaine epiduraly given postoperatively for 48 hours.Levobupivacaine at 0.2 mg/kg/hr given epiduraly postoperatively |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA physical status 1 and 2
2. Written and informed consent given by patient.
3. Patient scheduled for eledtive lower limb orthopedic surgeries under combined spinal epidural anesthesia. |
|
| ExclusionCriteria |
| Details |
1.Refusal for participation.
2.Known allergy or contraindication to the drugs used.
3.Cerebrovascular disease.
4.Intracranial hypertension |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in the pain by epidural analgesia in lower limb orthopedic surgeries. |
T0: First test dose intraoperatively
T60: 60 min after test dose
T150: 150 min after test does
T1: 1 hour postoperatively
T2: 2 hours postoperatively
T4: 4 hours postoperatively
T8: 8 hours postoperatively
T12: 12 hours postoperatively
T16: 16 hours postoperatively
T24: 24 hours postoperatively
T36: 36 hour postoperatively
T48: 48 hour postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Lower incidence of hypotension and bradycardia
2.Incidence of PONV |
T0: First test dose intraoperatively
T60: 60 min after test dose
T150: 150 min after test does
T1: 1 hour postoperatively
T2: 2 hours postoperatively
T4: 4 hours postoperatively
T8: 8 hours postoperatively
T12: 12 hours postoperatively
T16: 16 hours postoperatively
T24: 24 hours postoperatively
T36: 36 hour postoperatively
T48: 48 hour postoperatively |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/07/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
post operative pain is troublesome after orthopedic surgeries, effective pain relief causes early and smooth recovery. to provide effective analgesia we intend to compare 0.2% ropivacaine and 0.25% levobupivacaine. via epidural route. |