| CTRI Number |
CTRI/2024/04/065419 [Registered on: 08/04/2024] Trial Registered Prospectively |
| Last Modified On: |
04/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Perioperative hemodynamic differences in unilateral and bilateral subarachnoid block. |
|
Scientific Title of Study
|
Comparison of unilateral and bilateral subarachnoid block for differences in perioperative hemodynamic parameters in patients undergoing elective lower limb surgeries: A Randomized comparative study. |
| 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 Allu Pavan Kumar |
| Designation |
Post Graduate Student |
| Affiliation |
ABVIMS and Dr RML HOSPITAL |
| Address |
Department of Anaesthesia, PGI BUILDING,
ABVIMS and Dr RML Hospital
Central
DELHI
110001
India |
| Phone |
8096932566 |
| Fax |
|
| Email |
pavankumarallu116@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohandeep kaur |
| Designation |
Professor |
| Affiliation |
ABVIMS and Dr RML HOSPITAL |
| Address |
Room no. 301,
Department of Anaesthesia,
PGI building,
ABVIMS and Dr. RML Hospital,
New Delhi
Central
DELHI
110001
India |
| Phone |
9868952253 |
| Fax |
|
| Email |
mdkaur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Allu Pavan Kumar |
| Designation |
Post Graduate Student |
| Affiliation |
ABVIMS and Dr RML HOSPITAL |
| Address |
Room no 304, Department of Anaesthesia ABVIMS and Dr RML Hospital
Central
DELHI
110001
India |
| Phone |
8096932566 |
| Fax |
|
| Email |
pavankumarallu116@gmail.com |
|
|
Source of Monetary or Material Support
|
| Atal Bihari Vajpayee Institute of Medical sciences Dr. Ram Manohar Lohia Hospital |
|
|
Primary Sponsor
|
| Name |
ABVIMS and Dr RML Hospital |
| Address |
Room no 304 , Department of Anaesthesia,ABVIMS DR RML HOSPITAL
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 |
| Dr Allu Pavan Kumar |
ABVIMS and Dr RML Hospital |
Department of Anaesthesia ABVIMS and Dr RML Hospital
New Delhi
Central
DELHI |
8096932566
pavankumarallu116@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, ABVIMS and Dr RML Hospital |
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 |
Bilateral subarachnoid block |
Under all aseptic conditions and in lateral decubitus position subarachnoid block will be given in appropriate space using 25G Quinckie’s spinal needle with 2.8ml of 0.75% hyperbaric ropivacaine plus 0.2ml of fentanyl (50mcg/cc) and patients will be turned supine immediately. |
| Intervention |
Unilateral subarachnoid block |
Under all aseptic conditions and in lateral decubitus position subarachnoid block will be given in appropriate space using 25G Quinckie’s spinal needle with 2.8ml of 0.75% hyperbaric ropivacaine plus 0.2ml of fentanyl (50mcg/cc) and patients will be maintained in lateral decubitus position for 15 minutes and then turned supine on OT table. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients posted for elective unilateral lower limb surgeries.
2. ASA physical status I&II(excluding patients on antihypertensive or vasodilators).
3. Surgeries with expected duration of less than 90 minutes. |
|
| ExclusionCriteria |
| Details |
1. Known hypersensitivity to hyperbaric ropivacaine or fentanyl.
2. Any contraindications to Spinal anaesthesia.
3. Pregnant women.
4. Height less than 150cm.
5. Body mass index over 30kg m-2.
6. Patients who will be unable to lie in decubitus position.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean arterial pressure, systolic blood pressure, diastolic blood pressure. |
Parameters assessed every 3 minutes till highest level of sensory block achieved and then every 15 minutes until the full motor block recovery to modified bromage 6. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time of onset of sensory block, time to reach peak motor block on operative side, sensory block duration using VAS and motor block duration. |
Parameters assessed every 3 minutes till highest level of sensory block achieved and then every 15 minutes until the full motor block recovery to modified bromage 6 and duration will be calculated accordingly. |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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)
|
15/04/2024 |
| 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="5"
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
|
This is a Randomized comparative study of unilateral and bilateral subarachnoid block for differences in perioperative hemodynamic parameters in adult patients undergoing elective lower limb surgeries to be conducted in ABVIMS and Dr RML Hospital, New Delhi. This study has sample size of 92. Primary outcome is measuring mean arterial pressure, systolic and diastolic blood pressure. Secondary outcome is to duration of anaesthesia ( time of onset of sensory block and if time to reach peak motor block on operative side, sensory block duration and motor block duration). |