| CTRI Number |
CTRI/2024/01/061783 [Registered on: 24/01/2024] Trial Registered Prospectively |
| Last Modified On: |
23/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
TO COMPARE THE EFFECT OF HYPERBARIC LEVOBUPIVACAINE O.5% AND HYPERBARIC ROPIVACAINE 0.75 % IN SPINAL ANAESTHESIA IN PATIENTS UNDERGOING LOWER LIMB ORTHOPEDIC SURGERIES |
|
Scientific Title of Study
|
COMPARATIVE STUDY OF HYPERBARIC LEVOBUPIVACAINE O.5% AND HYPERBARIC ROPIVACAINE 0.75 % IN SPINAL ANAESTHESIA IN PATIENTS UNDERGOING LOWER LIMB ORTHOPEDIC 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 Mohammed Han B |
| Designation |
Post graduate student |
| Affiliation |
Jawaharlal Nehru Medical College and Hospitals , Ajmer , Rajasthan |
| Address |
Department of Anaesthesiology, Jawaharlal Nehru Medical College and Hospitals ,Ajmer ,Rajasthan
Ajmer
RAJASTHAN
305001
India |
| Phone |
8435060622 |
| Fax |
|
| Email |
mohammed.han811@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Maina Singh |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College and Hospitals , Ajmer , Rajasthan |
| Address |
Department of Anaesthesiology, New OT, 1st floor Jawaharlal Nehru Medical Hospitals ,Ajmer ,Rajasthan
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414097045 |
| Fax |
|
| Email |
mainasingh111@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Maina Singh |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College and Hospitals , Ajmer , Rajasthan |
| Address |
Department of Anaesthesiology, Jawaharlal Nehru Medical College and Hospitals ,Ajmer ,Rajasthan
RAJASTHAN
305001
India |
| Phone |
9414097045 |
| Fax |
|
| Email |
mainasingh111@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College and Hospital, Ajmer,Rajasthan,India,305001 |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Medical College and Hospitals |
| Address |
Jawaharlal Nehru Medical College and Hospitals , Ajmer, Rajasthan, India , 305001 |
| Type of Sponsor |
Government 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 Mohammed Han B |
Jawaharlal Nehru Medical College and Hospitals , Ajmer, Rajasthan |
Orthopaedics Operation Theater, Department of Anaesthesiology , 2nd floor J.L.N Hospital OPD Building, Jawaharlal Nehru Medical College and Hospitals , Ajmer ,Rajasthan
Ajmer
RAJASTHAN |
8435060622
mohammed.han811@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee JLN medical college ajmer |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M966||Fracture of bone following insertion of orthopedic implant, joint prosthesis, or bone plate, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Levobupivacaine (H) 0.5% |
With due approval from institutional ethical committee, A 50 participants who will be undergoing various lower limb orthopaedic surgeries will be given inj.Levobupivacaine 0.5% hyperbaric 3ml intrathecally as a single time injection. And will be followed for duration of analgesia , onset and duration of sensory block,motor block and haemodynamic changes. A written informed consent will be taken prior to procedure |
| Comparator Agent |
Ropivacaine 0.75% (H) |
With due approval from institutional ethical committee, A 50 participants who will be undergoing various lower limb orthopaedic surgeries will be given inj.Ropivacaine 0.75% hyperbaric 3ml intrathecally as a single time injection. And will be followed for duration of analgesia , onset and duration of sensory block,motor block and haemodynamic changes. A written informed consent will be taken prior to procedure |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients posted for elective Lowerlimb orthopaedic surgery ASA status 1 and 2 |
|
| ExclusionCriteria |
| Details |
Age less than 20 years and age above 60 years
ASA status 3 and 4
Any known hypersensitivity or contra indication to bupivacaine or ropivacaine
Patients with history of coagulopathy
Patients with spine deformity
Patients with local skin infection at site of injection
Patients who had shivering even before administering spinal anaesthesia |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of Analgesia |
Perioperatively,at 5 min, at 10min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Onset & duration of sensory block
Onset & duration of motor block
Haemodynamic variability |
Perioperatively,at 5 min, at 10 min |
|
|
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
31/01/2024 |
| 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="0"
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
|
This will be a hospital based prospective, randomised, double blind study conducted to compare the duration of analgesia, onset and duration of sensory and motor block and side effects of Hyperbaric Levobupivacaine 0.5% and hyperbaric ropivacaine 0.75% in patients undergoing Lowerlimb orthopaedic surgery. For this study Adult population between 20 years to 60 years of age group with ASA grade 1 and 2 with exemption of all exclusion criteria mentioned above and undergoing Lowerlimb orthopaedic surgery. Primary objective of the study is to assess the duration of analgesia. The secondary objective of the study is to assess the onset and duration of sensory block, onset and duration of motor block, haemodynamic parameters and its side effects. Participants are allocated into two different groups, each with 50 number sample size. Group R will receive 0.75% Hyperbaric ropivacaine 3ml intrathecally and group L will receive 0.5% Hyperbaric Levobupivacaine 3ml intrathecally.Preanaesthetic evaluation will be done on the day before surgery. Informed written consent obtained before procedure.Patients will be monitored intra operatively and post operatively upto 24 hours at pre described time intervals and documented. Data will be analysed statistically using standard quantitative and qualitative tests |