| CTRI Number |
CTRI/2021/09/036672 [Registered on: 21/09/2021] Trial Registered Prospectively |
| Last Modified On: |
31/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
COMPARING TWO LOCAL ANAESTHETIS FOR LOWER LIMB SURGERIES |
|
Scientific Title of Study
|
COMPARISON OF HYPERBARIC 0.5% LEVOBUPIVACAINE WITH HYPERBARIC 0.5 ROPIVACAINE FOR BLOCK CHARACTERISTICS IN LOWER LIMB ORTHOPEDIC SURGERIES UNDER SPINAL ANAESTHESIA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PRIYANKA MARWAHA |
| Designation |
Post graduate student |
| Affiliation |
ABVIMS and Dr RML hospital New Delhi |
| Address |
Department of Anaesthesia ABVIMS and Dr RML hospital New Delhi
New Delhi
110001
India
Central
DELHI
110001
India |
| Phone |
9310141057 |
| Fax |
|
| Email |
priyanka.marwaha22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR VIJAY KUMAR NAGPAL |
| Designation |
PROFESSOR AND CONSULTANT |
| Affiliation |
ABVIMS and Dr RML hospital New Delhi |
| Address |
Room no 310,Department of Anaesthesia ABVIMS and Dr RML hospital New Delhi
New Delhi
110001
India
Central
DELHI
110001
India |
| Phone |
9968304240 |
| Fax |
|
| Email |
nagpalvijaykumar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PRIYANKA MARWAHA |
| Designation |
Post graduate student |
| Affiliation |
ABVIMS and Dr RML hospital New Delhi |
| Address |
Department of Anaesthesia ABVIMS and Dr RML hospital New Delhi
New Delhi
110001
India
Central
DELHI
110001
India |
| Phone |
9310141057 |
| Fax |
|
| Email |
priyanka.marwaha22@gmail.com |
|
|
Source of Monetary or Material Support
|
| ABVIMS and Dr RML hospital New Delhi |
|
|
Primary Sponsor
|
| Name |
ORTHO OPERATION THEATRE FIRST FLOOR ABVIMS AND DR RAM MANOHAR LOHIA HOSPITAL |
| Address |
BABA KHARAK SINGH MARG NEW DELHI 110001 |
| 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 |
| PRIYANKA MARWAHA |
ABVIMS AND DR RAM MANOHAR LOHIA HOSPITAL |
DEPARTMENT OF ANAESTHESIA FIRST FLOOR OPERATION THEATRE NUMBER 2
Central
DELHI |
9310141057
priyanka.marwaha22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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 |
| Comparator Agent |
HYPERBARIC 0.5% LEVOBUPIVACAINE AND HYPERBARIC 0.5% ROPIVACANE |
With full aseptic precautions, inter vertebral space between L3-L4 vertebra will identified and a small skin wheal will be raised with 2 ml of lignocaine 2%. A 16 G Combined Spinal Epidural (CSE) needle will be inserted in L2 – L3 or L3 – L4 intervertebral space, advanced and epidural space recognized using loss of resistance technique. Using needle within needle technique, subarachnoid space will be identified by free flow of cerebro-spinal fluid (CSF). The study drug will be administered at a rate of 0.2ml/second. The spinal needle will be then withdrawn. Epidural catheter will be inserted and fixed at 9 cm |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiologists (ASA) grade I or II for elective orthopaedic lower limb surgery under spinal anesthesia
|
|
| ExclusionCriteria |
| Details |
Patients with-
1) Vertebral deformity / History of trauma to spine
2) Skin infection at the site of lumber puncture
3) Increased Intra- Cranial Pressure(ICP)
4) Allergy to amide local anaesthetics
• Coagulopathy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of motor block |
checked every 30 mins till movement returns |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TIME OF ONSET OF MOTOR AND SENSORY BLOCKADE |
10 MIN |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/10/2021 |
| Date of Study Completion (India) |
31/05/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/05/2022 |
|
Estimated Duration of Trial
|
Years="1"
Months="1"
Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To compare block characteristics
of hyperbaric 0.5% levobupivacaine with hyperbaric 0.5% ropivacaine in adult patients undergoing lower limb orthopedic surgeries under spinal
anaesthesia |