| CTRI Number |
CTRI/2024/01/062018 [Registered on: 30/01/2024] Trial Registered Prospectively |
| Last Modified On: |
27/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
To compare the effect of two local anaesthetic Ropivacaine versus Bupivacaine used in spinal anaesthesia for operation of lower abdomen . |
|
Scientific Title of Study
|
A COMPARATIVE STUDY OF THE EFFECTIVENESS OF INTRATHECAL HYPERBARIC ROPIVACAINE VERSUS HYPERBARIC BUPIVACAINE IN ELECTIVE LOWER ABDOMINAL PROCCEDURES. |
| 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 Saswati Nag (Porel) |
| Designation |
PGT |
| Affiliation |
ESIC PGIMSR ESI JOKA KOLKATA |
| Address |
3RD Floor OT Emergency Building
ESIC PGIMSR, ESIC JOKA KOKLKATA
3RD Floor OT Emergency Building
ESIC PGIMSR, ESIC JOKA KOKLKATA
South Twentyfour Parganas
WEST BENGAL
700104
India |
| Phone |
7003938439 |
| Fax |
|
| Email |
porelsaswati@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Juthika Biswas |
| Designation |
Associate Professor |
| Affiliation |
ESIC PGIMSR ESI JOKA KOLKATA |
| Address |
3RD Floor OT Emergency Building
ESIC PGIMSR, ESIC JOKA KOKLKATA
South Twentyfour Parganas
WEST BENGAL
700104
India |
| Phone |
7003938439 |
| Fax |
|
| Email |
drjuthikabiswas@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saswati Nag (Porel) |
| Designation |
PGT |
| Affiliation |
ESIC PGIMSR ESI JOKA KOLKATA |
| Address |
3RD Floor OT Emergency Building
ESIC PGIMSR, ESIC JOKA KOKLKATA
South Twentyfour Parganas
WEST BENGAL
700104
India |
| Phone |
7003938439 |
| Fax |
|
| Email |
porelsaswati@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESIC PGIMSR ESIC MEDICAL COLLEGE JOKA ESIC CORPORATION |
|
|
Primary Sponsor
|
| Name |
ESIC CORPORATION |
| Address |
ESIC PGIMSR , ESIC MEDICAL COLLEGE Diamond Harbour Rd, Bratachari Gram, Joka, Kolkata, West Bengal 700104 |
| 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 Saswati Nag Porel |
3rd floor OT emergency building and ward of ESIC PGIMSR ESIC Medical College Joka |
ESI-PGIMSR, ESIC Medical College & Hospital , Diamond Harbour Rd, Bratachari Gram , Joka , Kolkata, West Bengal 700104
Kolkata
WEST BENGAL |
7003938439
porelsaswati@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) Of ESIC PGIMSR ,ESIC Medical College Joka |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ASA 1 and 2 |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, (2) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Administration of hyperbaric intrathecal Ropivacaine / Bupivacaine in two groups of selected patients and comparing their effectiveness for lower abdominal surgeries |
Patient following inclusion criteria of either sex randomly allocated into two groups and one group given intrathecal hyperbaric Ropivacaine and the other intrathecal hyperbaric Bupivacaine and the effectiveness is compared in both the groups |
| Intervention |
Administration of intrathecal hyperbaric Ropivacaine/Bupivacaine and comparing the haemodynamics level of sensory and motor block and any adverse reaction between the two groups |
Patient following inclusion criteria of either sex randomly allocated into two groups and each group given either intrathecal hyperbaric Ropivacaine or intrathecal hyperbaric Bupivacaine and the effectiveness is compared in both the groups regarding haemodynamics level of sensory and motor block and requirement of first rescue analgesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient who gives consent
ASA Grade 1 and 2
Age:18-65 years
Any patient posted for elective lower abdominal procedure to be done under sub arachnoid block |
|
| ExclusionCriteria |
| Details |
Patient who does not give consent
Any contraindication to sub arachnoid block
Patients undergoing caesarean section
Expected duration of surgery more than 2 hrs |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effectiveness of intrathecal hyperbaric Bupivacaine versus Ropivacaine in elective lower abdominal procedures |
3 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Estimated time to achieve sensory block upto T10, maximum level of sensory block, time taken for 2 segment regression from maximum level of sensory block, time required for onset of motor block , time required for complete recovery of motor block, total duration of sensory block from time of injection to first demand for analgesia |
3 hours |
|
|
Target Sample Size
|
Total Sample Size="86"
Sample Size from India="86"
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)
|
14/02/2024 |
| 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="0"
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
|
The use of neuraxial anaesthesia has dramatically increased since 1997. Attenuation of Intraoperative anxiety and stress always remains a challenge in the practice of anaesthesia and it also has several detrimental effects on different systems of human body .Neuraxial anaesthesia techniques have several advantages ,including a decreased risk of failed intubation and aspiration of gastric contents, avoidance of depressant agents, decreased blood loss, ability of remaining awake. Hyperbaric bupivacaine is recommended because of its reliability of spread to the mid thoracic level and appropriate duration of action. Hyperbaric L.A descend downward when sitting and toward T4 when supine. Ropivacaine, a local anaesthetic with duration of action of 2-3 hours, has shown greater selectivity for sensory blockade along with lower systemic toxicity as compared to bupivacaine when used for spinal anaesthesia. - The purpose of our study was to compare effectiveness , the level of adequate block both sensory and motor with haemodynamic stability in patients undergoing spinal anaesthesia for lower abdominal surgery with intrathecal hyperbaric Ropivacaine and hyperbaric Bupivacaine. |