| CTRI Number |
CTRI/2023/11/059920 [Registered on: 16/11/2023] Trial Registered Prospectively |
| Last Modified On: |
20/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare level of sensory loss resulting in absence of pain sensation and blood pressure stability between supine position and ten degree upward table tilt after administration of spinal block in patients undergoing lower limb arthroscopic surgery. |
|
Scientific Title of Study
|
Comparison of spinal block characteristics and intraoperative haemodynamic parameters in ten degree reverse Trendelenburg position and supine position in patients undergoing lower limb arthroscopic surgery. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanmay Panda |
| Designation |
Post graduate resident |
| Affiliation |
Vardhman Mahavir medical college and Safdarjung hospital |
| Address |
Department of Anaesthesia and intensive care, Vardhman Mahavir medical college and Safdarjung hospital, Ansari Nagar, New Delhi, DELHI, 110029, India
South
DELHI
110029
India |
| Phone |
8117825960 |
| Fax |
|
| Email |
sanmaypanda1995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Parul Mullick |
| Designation |
Professor and Consultant |
| Affiliation |
Vardhman Mahavir medical college and Safdarjung hospital |
| Address |
Department of Anaesthesia and intensive care, Vardhman Mahavir medical college and Safdarjung hospital, Ansari Nagar, New Delhi, DELHI, 110029, India
South
DELHI
110029
India |
| Phone |
9810606262 |
| Fax |
|
| Email |
drparulmullick@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Parul Mullick |
| Designation |
Professor and Consultant |
| Affiliation |
Vardhman Mahavir medical college and Safdarjung hospital |
| Address |
Department of Anaesthesia and intensive care, Vardhman Mahavir medical college and Safdarjung hospital, Ansari Nagar, New Delhi, DELHI, 110029, India
South
DELHI
110029
India |
| Phone |
9810606262 |
| Fax |
|
| Email |
drparulmullick@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir medical college and Safdarjung Hospital |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir medical college and Safdarjung Hospital |
| Address |
Vardhman Mahavir medical college and Safdarjung Hospital, Ansari Nagar, New Delhi, 110029 |
| 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 Sanmay Panda |
Vardhman Mahavir medical college and Safdarjung Hospital |
Vardhman Mahavir medical college and Safdarjung Hospital, Ansari Nagar, New Delhi, 110029
South
DELHI |
8117825960
sanmaypanda1995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vardhman Mahavir medical college and Safdarjung 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 |
Supine position after administration of spinal block. |
In supine (S) group, immediately after the administration of drug into the subarachnoid space
the patient will be put into supine position with the operating table parallel to the floor for the entire duration of the surgery and maximal level of sensory block will be defined as number of spinal segments blocked above T12 at 20 minutes after administration of drug into subarachnoid space. |
| Intervention |
Ten degree reverse Trendelenburg position after administration of spinal block. |
In reverse Trendelenburg (RT) group, immediately after the administration of drug into the
subarachnoid space the patient will be put into supine position with the operating table tilted
ten degrees upwards with respect to the floor for the entire duration of surgery and maximal level of sensory block will be defined as number of spinal segments blocked above T12 at 20 minutes after administration of drug into subarachnoid space. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients aged 18 to 65 years
2.Belonging to American Society of Anesthesiologists (ASA) physical status class I or II
3.Undergoing lower limb surgery of expected duration less than two hours under spinal anaesthesia. |
|
| ExclusionCriteria |
| Details |
1.Patients who are pregnant
2.Obese (BMI > 30 kg/m2)
3.Height <165 cms and >180 cms
4.Known spinal anomaly
5.Local infection
6.Coagulopathies
7.On anticoagulant medication
8.Any contraindication to spinal anaesthesia. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the number of spinal segments blocked above T12 dermatomal level after administration of drug into subarachnoid space in patients undergoing lower limb surgery in ten-degree reverse Trendelenburg position and supine position. |
To compare the number of spinal segments blocked above T12 dermatomal level at 20 mins after administration of drug into subarachnoid space in patients undergoing lower limb surgery in ten-degree reverse Trendelenburg position and supine position. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare the incidence of hypotension & vasopressor requirement.
2.To compare the time taken for regression of spinal block till T12 dermatome level. |
1.To compare the incidence of hypotension & vasopressor requirement at baseline, time of spinal block, 2 mins after spinal block, 4 mins after spinal block & so on.
2.To compare the time taken for regression of spinal block till T12 dermatome level. Level of block to be assessed at 20 mins, 40 mins, 60 mins, 80 mins & 120 mins after administration of drug into subarachnoid space. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
28/11/2023 |
| 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="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
|
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Brief Summary
|
This study is a prospective, interventional, comparative randomized study To compare the spinal block characteristics and intraoperative haemodynamic parameters in ten degree reverse Trendelenburg position and supine position in patients undergoing lower limb arthroscopic surgery. In supine (S) group, immediately after the administration of drug into the subarachnoid space the patient will be put into supine position with the operating table parallel to the floor. In reverse Trendelenburg (RT) group, immediately after the administration of drug into the subarachnoid space the patient will be put into supine position with the operating table tilted ten degrees upwards with respect to the floor. The level of spinal block will be assessed bilaterally in the midclavicular line using the cold touch method with an alcohol swab every 30 seconds until onset of sensory block. Maximal level of sensory block defined as number of spinal segments blocked above T12 at 20 min after administration of drug into subarachnoid space. Surgical intervention will begin after adequate level of sensory block is achieved for the surgical procedure. Patients will be monitored throughout the surgery and readings of heart rate, systolic, diastolic and mean arterial pressure and oxygen saturation will be noted at time of spinal block, at 2 mins, 5 mins ,10 mins, 20 mins and 30 mins, thereafter every 15 mins till the end of surgery. Any episode of bradycardia or hypotension will be noted and managed accordingly. Intra operative blood loss, requirement of IV fluids and blood products will be monitored.
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