| CTRI Number |
CTRI/2023/02/050035 [Registered on: 24/02/2023] Trial Registered Prospectively |
| Last Modified On: |
23/02/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between hyperbaric Ropivacaine and hyperbaric Bupivacaine in patients undergoing inguinal and perineal surgeries under spinal anaesthesia. |
|
Scientific Title of Study
|
A Comparative evaluation of Hyperbaric Ropivacaine versus Hyperbaric Bupivacaine for elective Inguinal and Perineal surgery under spinal anaesthesia. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MF-241/2021 |
DCGI |
| MF-241/2021 date: 13/08/2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhavini Shah |
| Designation |
Professor |
| Affiliation |
DR D Y PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE, PUNE |
| Address |
Department of Anaesthesiology, Dr. D.Y. Patil medical college, hospital and research centre, Sant tukaram nagar, Pimpri, Pune
Department of Anaesthesiology, Dr. D.Y. Patil medical college, hospital and research centre, Sant tukaram nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
09850829994 |
| Fax |
|
| Email |
drbhavinishah71@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dipanjali Mahanta |
| Designation |
Senior Resident |
| Affiliation |
Dr. D Y Patil Vidyapeeth |
| Address |
Department of Anesthesiology, Dr D Y Patil medical college hospital and research centre, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
09673586122 |
| Fax |
|
| Email |
dipanjalimahanta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dipanjali Mahanta |
| Designation |
Senior resident |
| Affiliation |
Dr D Y Patil Vidyapeeth |
| Address |
Department of Anesthesiology, Dr D Y Patil Medical college hospital and research centre, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
09673586122 |
| Fax |
|
| Email |
dipanjalimahanta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr D Y Patil Medical College Hospital and Research Centre Pune Maharashtra |
|
|
Primary Sponsor
|
| Name |
Dr D Y Patil Medical college Hospital and Research Centre Pune |
| Address |
Department of Anaesthesiology, Dr. D.Y. Patil medical college, hospital and research centre, Sant tukaram nagar, Pimpri, Pune |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Bhavini Shah |
DR DY PATIL MEDICAL COLLEGE PUNE |
Department of Anaesthesiology, Dr DY Patil medical college hospital and research centre Sant tukaram nagar Pimpri Pune
Pune
MAHARASHTRA |
09850829994
drbhavinishah71@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| College Scientific 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 |
Injection Bupivacaine heavy |
Dose: 20mg intrathecal route.
Duration:20minutes post spinal anaesthesia
We observe for onset, duration, extend and recovery time of sensory block (analgesia to pinprick)
observe the duration and degree of lower limb motor block (with James modified Bromage Scale)
observe the time to first micturition
observe the hemodynamic parameters (heart rate, blood pressure) and observe for any incidence of adverse events and for the need of general anesthesia (GA) supplementation in comparison to spinal anesthesia achieved with injection ropivacaine heavy.
|
| Intervention |
Injection ropivacaine heavy |
Dose 30mg intrathecal route.
Duration 20 minutes post spinal anesthesia
We observe for onset, duration, extend and recovery time of sensory block (analgesia to pinprick) observe the duration and degree of lower limb motor block (with James modified Bromage Scale) observe the time to first micturition observe the hemodynamic parameters (heart rate, blood pressure) and observe for any incidence of adverse events and for the need of general anesthesia (GA) supplementation in comparison to spinal anesthesia achieved with injection bupivacaine heavy. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients undergoing inguinal and perineal surgeries under spinal anesthesia.
2. Hemodynamically stable patients with all routine investigations within normal limits with no co-morbidities.
3. Patients who are not on any cardiac related drugs.
4. Availability of informed consent.
|
|
| ExclusionCriteria |
| Details |
1. Patients with ASA physical status 3 or more.
2. Patients below 18 years and above 60 years of age.
3. Patients posted for emergency procedures.
4. Patients with major neurological, cardiac, respiratory, metabolic, renal, hepatic
disease or any coagulation abnormalities.
5. Patients contraindicated for spinal anesthesia.
6. Patients with known allergies to the study drugs.
|
|
|
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 |
Time taken for the onset of sensory block followed by
Time taken to T8 level sensory blockade post subarachnoid block with either injection bupivacaine heavy or injection ropivacaine heavy.
|
2 minutes to 15 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration of sensory blockade |
150 minutes |
| Onset and duration of motor blockade |
2 minutes to 150 minutes |
| Intraoperative hemodynamic parameters like heart rate, blood pressure |
2 minutes to 150 minutes |
| Time of first micurition |
At 120 to 150 minutes post subarachnoid block |
| 5. To observe for any incidence of adverse events and for the need of general anesthesia (GA) supplementation. |
2 to 20 minutes |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/03/2023 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Spinal anesthesia for most lower abdominal and lower limb surgeries are carried out using injection bupivacaine heavy, which produces effective autonomic, sensory and motor blockade of the dermatomes above and below the level of intrathecal injection. However, bupivacaine is a long-acting agents with increased risks of re-entrant arrhythmias and cardiac depression which lead to the development of ropivacaine, which has increased threshold in terms of risk of CVS or CNS toxicity unlike bupivacaine. Also, with the advent of day care surgical procedures and early postoperative patient mobilization to aid in better prognostic outcome, using a long-acting agent such as bupivacaine becomes a deterrent. Additionally, the use of hyperbaric ropivacaine for subarachnoid blockade is still in nascent stages in our country. We require more studies to evaluate and assess the degree of effective ascend as well as descend of sensory and motor block with hyperbaric ropivacaine in order to encourage more clinical use of this drug and help us take a step towards better patient mobilization and care postoperatively for routine day care surgeries. |