| CTRI Number |
CTRI/2024/07/070804 [Registered on: 18/07/2024] Trial Registered Prospectively |
| Last Modified On: |
14/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison Between Bupivacaine and Levo Bupivacaine in Spinal Anaesthesia. |
|
Scientific Title of Study
|
Comparing Anaesthesia Efficacy Between Bupivacaine and Levo isomer of Bupivacaine in Subarachnoid Block in Patients undergoing Infraumbilical 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 |
Aditi Soni |
| Designation |
Post graduate resident |
| Affiliation |
Sikkim Manipal University |
| Address |
Level 6 OT complex Department of anesthesiology CRH Sikkim Manipal University Tadong
East
SIKKIM
737102
India |
| Phone |
6263314911 |
| Fax |
|
| Email |
itsaditi0910@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Lhamo Dolma |
| Designation |
Assistant professor |
| Affiliation |
SIKKIM MANIPAL UNIVERSITY |
| Address |
Level 6 OT complex department of anesthesiology CRH Sikkim Manipal University Tadong
East
SIKKIM
737102
India |
| Phone |
8860394768 |
| Fax |
|
| Email |
lhamo.d@smims.smu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Aditi Soni |
| Designation |
Post Graduate Resident |
| Affiliation |
Sikkim Manipal University |
| Address |
Level 6 OT Complex Department of Anesthesiology CRH Sikkim Manipal University Tadong
East
SIKKIM
737102
India |
| Phone |
6263314911 |
| Fax |
|
| Email |
itsaditi0910@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Referral Hospital Sikkim Manipal institute of medical sciences |
|
|
Primary Sponsor
|
| Name |
Sikkim Manipal Institute of Medical Sciences |
| Address |
Level 6 OT Complex Department Of Anesthesiology Sikkim Manipal Institute Of Medical Sciences |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| ADITI SONI |
PG HOSTEL,CRH,SIKKIM MANIPAL UNIVERSITY,737102 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Aditi Soni |
Central referral hospital |
Level 6 OT Complex Department of anesthesiology Sikkim Manipal Institute of Medical Sciences
East
SIKKIM |
6263314911
itsaditi0910@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sikkim Manipal Institute of Medical Sciences Institution 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 |
3 mL of Bupivacaine Vs 3 mL of Levo Bupivacaine in Sub Arachnoid Block |
Block Characterstics in both group will be assesed using loss of pin prick sensation for sensory and modified Bromage Scale for intensity and quality of motor block.Haemodynamic variables will also be recorded.Sensory block onset is defined by time from onset till patient complaints of pain or VAS more than or equal to score of 3 general side effects like nausea vomiying will also be noted |
| Intervention |
COMPARING ANESTHESIA EFFICACY BETWEEN BUPIVACAINE AND LEVO ISOMER OF BUPIVACAINE IN PATIENTS UNDERGOING INFRAUMBILICAL SURGERIES |
The drugs will be deposited in the intrathecal space through a spinal needle and assessment of anesthetic efficacy of the drugs will be conducted post spinal anesthesia in all the patients undergoing infraumbilical surgeries |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Asa grade I and II adult patients between 18-60 years and body weight 45-65kg of either sex consenting to participate and who are to undergo elective or emergency infraumbilical surgeries |
|
| ExclusionCriteria |
| Details |
Patients refusal
Patient with history of allergy to drug used in study
Patient with gross spinal abnormality localized skin infection coagulopathy neuropathy and head injury
Asa grade III and IV
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Anesthesia Efficacy
|
From Time of Onset of Anesthesia till Patient complaint of Pain or Visual Analogue Score more than or equal to 3 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Find Out any Unwanted Side Effects like Cardiotoxicity, Neurotoxicity, General Side Effects |
From the onset of Anesthesia till the patient complaint of Pain or Visual Analogue Score More than Or equal to 3 |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
30/07/2024 |
| 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="6"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 22-06-2025 and end date provided 22-06-2040?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
COMPARING ANESTHESIA EFFICACY BETWEEN BUPIVACAINE AND LEVO-BUPIVACAINE IN PATIENTS UNDERGOING INFRAUMBILICAL SURGERIES: WHERE THE TWO DRUGS WILL BE GIVEN IN SUBARACHNOID SPACE AND THEIR EFFICACY WILL BE COMPARED IN TERMS OF ONSET OF ANESTHESIA,DURATION OF ANESTHESIA AND HAEMODYNAMIC SIDE EFFECTS SUCH AS HYPOTENSION,ARRYTHMIAS,BRADY OR TACHY ARRYTHMIAS OR ANY NEUROLOGICAL SIDE EFFECTS SUCH AS TINGLING, NUMBNESS,SEIZURES WILL BE NOTED. EPIDURAL WILL BE USED AS A RESCUE ANALGESIA IF DURATION OF SURGERY PROLONGS OR PATIENT COMPLAINTS OF PAIN AFTER SUB ARACHNOID BLOCK. |