CTRI Number |
CTRI/2023/05/052606 [Registered on: 12/05/2023] Trial Registered Prospectively |
Last Modified On: |
10/05/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
A comparative study of heavy ropivacaine 0.75% with heavy bupivacaine 0.5% in spinal anaesthesia for below umbilical surgeries. |
Scientific Title of Study
|
A prospective randomized comparative study of hyperbaric ropivacaine 0.75% versus hyperbaric bupivacaine 0.5% in spinal anaesthesia for elective infraumbilical surgeries |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Anula Sharan Dsouza |
Designation |
Junior resident |
Affiliation |
Kasturba Medical College |
Address |
Department of Anaesthesiology Kasturba Medical College
KMC Manipal Kasturba Medical College
KMC Manipal
Udupi KARNATAKA 576104 India |
Phone |
9686425707 |
Fax |
|
Email |
anusap04@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Deepali Shetty |
Designation |
Senior resident |
Affiliation |
Kasturba medical college |
Address |
Department of Anaesthesiology
Kasturba medical college, Manipal
Kasturba medical college, Manipal Udupi KARNATAKA 576104 India |
Phone |
7349215023 |
Fax |
|
Email |
deepali.shetty@manipal.edu |
|
Details of Contact Person Public Query
|
Name |
Dr Deepali Shetty |
Designation |
Senior resident |
Affiliation |
Kasturba medical college |
Address |
Department of Anaesthesiology
Kasturba medical college
KMC Manipal
Kasturba medical college
KMC Manipal Udupi KARNATAKA 576104 India |
Phone |
7349215023 |
Fax |
|
Email |
deepali.shetty@manipal.edu |
|
Source of Monetary or Material Support
|
Kasturba Medical College Manipal
Manipal Udupi
576104 |
|
Primary Sponsor
|
Name |
Kasturba medical college |
Address |
Manipal academy of higher education
Manipal , Udupi , Karnataka 5756104 |
Type of Sponsor |
Private 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 Anula Sharan Dsouza |
Kasturba medical college |
Department of anaesthesiology
Kasturba medical college
Manipal academy of higher education
Manipal , Udupi , Karnataka 576104 Udupi KARNATAKA |
9686425707
anusap04@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Kasturba medical college and Kasturba Medical College 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 |
0.5% Hyperbaric Bupivacaine |
Group B - 2.6ml of 0.5% Hyperbaric Bupivacaine
Administered Intrathecally at the start of procedure
Duration of action : 3 hours |
Intervention |
0.75% Hyperbaric Ropivacaine |
Group R : 2.6ml of 0.75% hyperbaric ropivacaine
Administered Intrathecally at the start of procedure
Duration of action : 3 hours |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1. Patients undergoing elective infraumbilical or
lower limb surgery under spinal anaesthesia.
2. Who belong to American Society of
Anesthesiologists Physical Status I or II will be
included in the study. |
|
ExclusionCriteria |
Details |
• Patient refusal
• Infection at the site of injection
• Uncorrected hypovolemia
• Allergy
• Increased intracranial pressure
• Coagulopathy
• Sepsis
• Fixed cardiac output states
• Indeterminate neurological disease
• Patients in altered mental status
• Pregnant females.
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
On-site computer system |
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
1.Time taken for onset of sensory and motor blockade.
2.Time to achieve maximum sensory level.
3.Time for 2-segment regression.
4.Time taken for sensory and motor recovery.
|
1.Sensory blockade immediately after administering spinal anaesthesia ( baseline ) followed by every 2 min from baseline until T10 block achieved
2.Motor blockade at
Baseline followed by every 2 min from baseline till bromage scale - 3 or complete motor blockade achieved.
3.Sensory level will be checked at baseline followed by every 5 minutes from
baseline thereafter till the end of 1 hour, and every 15 minutes thereafter till 2-segment regression |
|
Secondary Outcome
|
Outcome |
TimePoints |
Mean change in vital parameters (heart rate, blood pressure , respiratory rate, oxygen saturation)
Frequency of adverse events
|
1.Blood pressure will be recorded at baseline ( immediately after administering spinal anaesthesia ) followed by every 5 minutes from baseline for the first hour and every 15 minutes thereafter till complete sensory and motor recovery.
2. Heart rate will be recorded at baseline followed by every 5 minutes from baseline for the first hour and every 15 minutes thereafter till recovery from sensory and motor blockade. |
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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 4 |
Date of First Enrollment (India)
|
22/05/2023 |
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 Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
Not published in any international or national journal. |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
The duration of the sensory block with ropivacaine is found to be similar with bupivacaine and the motor block was significantly shorter. Due to less lipophilic property and stereo selective structure ropivacaine has significantly higher threshold for cardio toxicity and CNS toxicity than bupivacaine. As hyperbaric ropivacaine is now commercially available we plan to study its efficacy and safety compared to the routine hyperbaric bupivacaine in patients undergoing spinal anesthesia for elective infraumbilical surgeries. Anesthesiology resident (blinded to the study) will examine the patients preoperatively to ensure that the inclusion criteria is met. Informed consents will be taken of the eligible participants, and they will be kept nil per oral for solids 6 hours and for liquids 2 hours prior to the surgery. Patients will be allocated into two groups - Group B receiving - 5% hyperbaric bupivacaine and Group R - receiving 0.75% hyperbaric ropivacaine. Onset of analgesia at T10 will be noted. The sensory level will be checked every 2 minutes as described above until the level does not ascend any further for 4 consecutive readings. Sensory level will be checked every 5 minutes thereafter till the end of 1 hour, and every 15 minutes thereafter till 2-segment regression and sensory recovery (around S2-S4 segments) occur. Motor blockade will be assessed by modified Bromage scale (0-1-2-3) at similar intervals as assessment of sensory block. Motor blockade will be evaluated at 2-minute intervals till a modified Bromage score of 3 is obtained or till maximum motor blockade is achieved. This time is noted as onset of motor blockade. The time at which ankle movement returns is noted to indicate recovery from motor blockade. Blood pressure will be recorded every 5 minutes for the first hour and every 15 minutes thereafter till complete sensory and motor recovery More than a 25% decrease in mean arterial pressure will be treated with intravenous fluids and vasopressor (mephentermine 3 mg/bolus). Heart rate will be recorded every 5 minutes for the first hour and every 15 minutes thereafter till recovery from sensory and motor blockade. A heart rate < 50/min will be considered as bradycardia but will be treated only if associated with hypotension. A respiratory rate less than 8/min or pulse oximetry values less than 95% on room air will be taken as significant and nasal oxygen 3 to 5 litres/min will used as rescue. Any adverse effects such as nausea, vomiting, pruritus will be noted. The inference concluded from the study shall enhance our knowledge about 0.75% hyperbaric ropivacaine and may lead to preferential selection of the drug. |