| CTRI Number |
CTRI/2023/04/051449 [Registered on: 10/04/2023] Trial Registered Prospectively |
| Last Modified On: |
30/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
comparsion of bupivacine heavy with fentanyl and ropivacine heavy with fentanyl for spinal anaesthesia |
|
Scientific Title of Study
|
A Randomized prospective study for clinical comparsion of intrathecal hyperbaric bupivacaine with fentanyl versus intrathecal hyperbaric ropivacine with fentanyl for patients undergoing orthopedic lowerlimb surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Meenakshi Telang |
| Designation |
Junior resident |
| Affiliation |
Subharti University |
| Address |
Dept of Anesthesiology
Room no 6, Begum Hazrat Mahal Hostel, Subharti university, Meerut
Delhi- Meerut bypass, Meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9977769160 |
| Fax |
|
| Email |
telang.meenakshi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Salony Agarwal |
| Designation |
Professor |
| Affiliation |
Swami Vivekanand Subharti University |
| Address |
Dept. of Anesthesiology and critical care, Subharti Hospital, Meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9557038599 |
| Fax |
|
| Email |
drsumitsalonyagarwal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Meenakshi Telang |
| Designation |
Junior resident |
| Affiliation |
Subharti University |
| Address |
Junior resident, Dept. of Anesthesiology, Room no 6, Begum Hazrat Mahal Hostel, Subharti university, Meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9977769160 |
| Fax |
|
| Email |
telang.meenakshi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Swami Vivekanand Subharti University, Meerut |
|
|
Primary Sponsor
|
| Name |
Dr Meenakshi Telang |
| Address |
Room no 6, Begum hazrat mahal hostel, Subharti University,Meerut |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Subharti Medical College |
Swami Vivekanand Subharti University, Delhi Meerut bypass, Meerut |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Meenakshi Telang |
CHHATRAPATI SHIVAJI SUBHARTI HOSPITAL |
DEPT OF ANESTHESIOLOGY, 1ST FLOOR, SUBHARTI HOSPITAL, DELHI MEERUT BYPASS, MEERUT, U.P.
Meerut
UTTAR PRADESH |
9977769160
telang.meenakshi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| University Ethics Committee (Medical) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ASA 1 & 2 patients undergoing orthopedic lower limb surgeries |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
3 ml of 0.5% Bupiavacaine (H) with 0.5 ml NS |
3 ml of 0.5% Bupivacaine (H) with 0.5 ml fentanyl under SA FOR SURGERY LASTING UPTO 180 MINS |
| Intervention |
Bupivacaine with Fentanyl, |
3 ml of 0.5% Bupivacaine (H) with 0.5 ml fentanyl under SA
FOR SURGERY LASTING UPTO 180 MINS |
| Intervention |
Ropivacaine with fentanyl |
3 ml of 0.75% ropivacaine heavy with 0.5 ml fenatnyl under SA FOR SURGERY LASTING UPTO 180 MINS |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA GRADE 1 & 2, WEIGHING 55-85 KG SCHEDULED FOR ELECTIVE ORTHOPEDIC LOWER LIMB SURGERY. |
|
| ExclusionCriteria |
| Details |
1. Uncooperative patient.
2. Refusal to technique or enrolment for study.
3. Known hypersensitivity to study drugs or using any drug that modifies pain perception.
4. Deformity/Abnormality of spinal column.
5. Infection at site of lumbar puncture.
6. Patients with physical status of ASA grade III or greater.
7. Patients with history of severe cardiac or pulmonary disease, poorly controlled hypertension.
8. Morbidly obese patients, neurologic or psychological disease, hepatic or renal dysfuction, endocrinal or metabolic disorders.
9. Bleeding or coagulation disorder.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To evaluate and compare the onset and duration of sensory and motor blockade after intrathecal bupivacaine heavy with fentanyl and intrathecal ropivacaine heavy with fentanyl.
2.To evaluate and compare the time taken for two dermatome sensory regression to S1 after intrathecal administration of bupivacaine with fentanyl and ropivacaine with fentanyl.
3.To compare the post op analgesia.
4.To evaluate and compare the hemodynamic changes of systemic BP and HR. |
immediate postop,
1st 30 mins postop,
1 hour postop,
2 hours postop,
3 hours postop,
4 hours postop,
5 hours postop,
6 hours postop |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To determine any side effects due to Bupivacaine, Ropivacaine or Fentanyl during the study period. |
1 hour post operatively |
|
|
Target Sample Size
|
Total Sample Size="117"
Sample Size from India="117"
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)
|
10/04/2023 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [telang.meenakshi@gmail.com].
- For how long will this data be available start date provided 12-03-2023 and end date provided 12-12-2026?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
A randomised prospective study for clinical
comparison of intrathethecal Hyperbaric Bupivacaine with Fentanyl versus
intrathecal Hyperbaric Ropivacaine with fentanyl for patients undergoing
orthopedic lower limb surgeries. |