| CTRI Number |
CTRI/2024/10/074982 [Registered on: 09/10/2024] Trial Registered Prospectively |
| Last Modified On: |
08/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative study of intrathecal Levobupivacaine vs Bupivacaine vs Ropivacaine in perianal surgeries |
|
Scientific Title of Study
|
A Comparative study of 0.5 percentage hyperbaric Levobupivacaine, 0.5 percentage hyperbaric bupivacaine and 0.75 percentage hyperbaric ropivacaine for subarachnoid block in perianal surgeries : A randomized control trial |
| 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 Linda Monica Dsouza |
| Designation |
Second Year Post Graduate |
| Affiliation |
St John’s Medical College |
| Address |
Department of Anesthesiology, Second floor OT complex, St. John’s Medical College
Sarjapur-Marathahalli Road
Koramangala
Bangalore KARNATAKA 560034 India |
| Phone |
9481144595 |
| Fax |
|
| Email |
monicadsouza469@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Bindu George |
| Designation |
Professor |
| Affiliation |
St. Johns Medical College |
| Address |
Department of Anesthesiology, Second floor OT complex, St. Johns Medical College,
Bengaluru
Bangalore KARNATAKA 560034 India |
| Phone |
9342552324 |
| Fax |
|
| Email |
bindu575@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Bindu George |
| Designation |
Professor |
| Affiliation |
St. Johns Medical College |
| Address |
Department of Anesthesiology, Second floor OT complex, St. Johns Medical College,
Bengaluru
Bangalore KARNATAKA 560034 India |
| Phone |
9342552324 |
| Fax |
|
| Email |
bindu575@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology, Second floor OT complex, St. Johns Medical College, Bengaluru - 560034
Karnataka
India |
|
|
Primary Sponsor
|
| Name |
Linda Monica Dsouza |
| Address |
Department of Anesthesiology, Second floor OT complex, St.John’s Medical College
Sarjapur- Marathahalli road
Bengaluru- 560034
Karnataka
India |
| Type of Sponsor |
Other [] |
|
|
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 Linda Monica Dsouza |
St John’s Medical College and Hospital |
Department of Anesthesiology, Second floor OT complex, St Johns Medical College Sarjapur Road, Bengaluru - 560034 Bangalore KARNATAKA |
9481144595
monicadsouza469@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, St Johns Medical college, Bengaluru |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bupivacaine |
Subarachnoid block using 2.5ml of 0.5 % Hyperbaric Bupivacaine in perianal surgeries.
Time taken for the intervention is 5 to 20 minutes. |
| Comparator Agent |
Levobupivacaine |
Subarachnoid block using 2.5ml of 0.5% Hyperbaric Levobupivacaine in perianal surgeries.
Time taken for the intervention is 5 to 20 minutes. |
| Comparator Agent |
Ropivacaine |
Subarachnoid block using 2.5ml of 0.75% Hyperbaric Ropivacaine in perianal surgeries.
Time taken for the intervention is 5 to 20 minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiologists (ASA) physical status Grade 1 and Grade 2 patients scheduled for elective or emergency perianal surgery requiring subarachnoid block
|
|
| ExclusionCriteria |
| Details |
1.Patients with spine deformity
2.Pregnant patients
3.Patients with coagulation and bleeding disorders
4.Sensitive to drugs being studied
5.Patient refusal |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare duration of sensory blockade
To compare duration of motor blockade |
Sensory blockade- Time interval between onset of block (T12 dermatomal level)and two segment dermatomal regression
Motor blockade- Time between onset of motor blockade(Modified Bromage scal 3) to complete regression of motor block (Modified Bromage Scale 0 ) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the onset of action of sensory blockade
|
Time taken to reach T12 dermatomal level assessed by sterile pin prick every 2 minutes till level reached |
| To compare onset of motor blockade |
Time taken to reach Modified Bromage score of 3 will be assessed every 2 minutes |
| Any adverse hemodynamic effects or side effects |
Following injection of the drug intrathecally, baseline vitals will be assessed every 3 minutes for first 15 minutes & every 5 minutes thereafter till the end of procedure.
Any side effects like nausea, vomiting, pruritis & sedation will also be noted |
|
|
Target Sample Size
|
Total Sample Size="69" Sample Size from India="69"
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 1 |
|
Date of First Enrollment (India)
|
19/10/2024 |
| 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="1" 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
|
A comparative study of 0.5% Hyperbaric Levobupivacaine, 0.5% Hyperbaric Bupivacaine and 0.75% Hyperbaric Ropivacaine for spinal anesthesia in perianal surgeries: A randomized control trial Spinal anaesthesia is the most efficient technique that provides fast surgical anaesthetic block through very small dose of local anaesthesia into the subarachnoid space. It produces profound nerve block to large part of the body. However, the control of spread of local anaesthetic through the CSF to provide block that is adequate for the proposed surgery is a challenge. Bupivacaine is a racemic mixture containing equal proportions of S and R isomers. It is being used because of its long duration of action and beneficial sensory and motor block. However this might be a disadvantage for short to intermediate duration procedures. Levobupivacaine is S enantiomer of bupivacaine and better alternative to bupivacaine in terms of cardiac and central nervous system toxicity .It produces less motor block than bupivacaine when administered intrathecally at low doses. Ropivacaine is less lipophilic than bupivacaine and has less affinity towards large myelinated motor fibers resulting in relatively reduced motor blockade.This feature of high sensory and low motor affinity is advantageous in cases where motor blockage isn’t desired. Perianal surgeries are short procedures that require good intra operative anesthesia and post operative analgesia since perianal region have dense sensory supply. Hence profound sensory block over motor block for short period is desired. This study will be done to compare the duration of sensory and motor blockade of 0.5% hyperbaric bupivacaine, 0.5% hyperbaric levobupivacaine and 0.75% hyperbaric ropivacaine. This study will include 69 ASA 1 and ASA 2 patients between the age group of 18 to 65 years undergoing perianal surgeries. Patients will be divided into 3 groups (23 each) randomly via computer generated sequence. A detailed preanesthetic evaluation and all relevant investigations will be done a day prior to surgery. All patients will be informed about the anaesthetic procedure and an informed consent will be taken for the same. Patients will be kept nil per oral- 6 hours for solids and 2 hours for clear liquids. Tablet Alprazolam 0.25mg will be given the night before the surgery and Tablet Pantoprazole 40 mg morning of the surgery. All patients will have a patent 20 Gauge intravenous peripheral line and will be preloaded with 500 ml of Ringer lactate solution.On the day of surgery, baseline vitals will be recorded. The patients will be monitored using standard monitors - Pulse Oximeter, Electrocardiogram (ECG) and Noninvasive Blood Pressure (NIBP).Under strict aseptic precaution, patient in sitting position, local anesthesia of skin will be given with 2ml of 2% lignocaine at L2-3 or L3-4 intervertebral space. Lumbar puncture will be done using 25G Quincke Babcock spinal needle. The drug will be injected slowly after confirming free and clear backflow of CSF. After injecting the drug, the patient will be made to sit for 1minute and then lie down in supine position. The primary outcome variable will be the duration of sensory and motor blockade. This will include the time taken for two segment regression and degree of block assessed by Modified Bromage scale. The secondary outcome will be to compare the onset of sensory and motor blockade. This will be assessed by time taken for the block to reach T12 and modified Bromage of 4.Any adverse hemodynamic effects will be added as secondary variable.The data collected will be tabulated for statistical analysis |