| CTRI Number |
CTRI/2023/07/055159 [Registered on: 13/07/2023] Trial Registered Prospectively |
| Last Modified On: |
12/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
To test the effectiveness of two drugs for spinal anaesthesia in below umbilical surgeries. |
|
Scientific Title of Study
|
Evaluation of hyperbaric levobupivacaine (0.5%) and hyperbaric bupivacaine (0.5%) in patients undergoing infra-umbilical surgeries |
| 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 Pranita Jain |
| Designation |
Junior Resident in Department of Anaesthesiology |
| Affiliation |
Gandhi Medical College, Bhopal |
| Address |
Operation theatre, 2nd floor, Department of anaesthesiology, Gandhi Medical College, Bhopal
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
9146196376 |
| Fax |
|
| Email |
pranitajain0508@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Surendra Raikwar |
| Designation |
Professor in Department of Anaesthesiology |
| Affiliation |
Gandhi Medical College, Bhopal |
| Address |
Operation theatre, 2nd floor, Department of Anaesthesiology, Gandhi Medical College, Bhopal
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
8989118989 |
| Fax |
|
| Email |
drskraikwar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajni Thakur |
| Designation |
Associate Professor in Department of Anaesthesiology |
| Affiliation |
Gandhi Medical College, Bhopal |
| Address |
Operation theatre, 2nd floor, Department of Anaesthesiology, Gandhi Medical College, Bhopal
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
9200062118 |
| Fax |
|
| Email |
dr.rajni_1507@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Gandhi medical College, Bhopal |
|
|
Primary Sponsor
|
| Name |
Not Applicable |
| Address |
Not Applicable |
| Type of Sponsor |
Other [NOT applicable] |
|
|
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 Pranita Jain |
Gandhi medical College Bhopal |
Department of Anaesthesiology, Block 1, room number 1, Hamidia Hospital, Gandhi medical College, Bhopal
Bhopal
MADHYA PRADESH |
9146196376
pranitajain0508@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S318||Open wound of other parts of abdomen, lower back and pelvis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Age group 18-60 years of either age. 2) Patients with ASA grade I and II 3) patients with average height (>5 feet). 4) All patients undergoing infra-umbilical surgeries |
|
| ExclusionCriteria |
| Details |
1) Patient refusal or not giving consent.
2) Patients with the Neurological disease,
bleeding diathesis, Coagulopathy disorders.
3) Patients with spine/Neurological deformities,
4) Local Skin infections or disease.
5) History of drug allergy.
6) Patients on tranquilizers, hypnotics, sedatives
and other psychotropic drugs.
7) Severe liver or kidney diseases.
8) ASA grade III and IV, V.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effects of Hyperbaric Levobupivacaine (0.5%) & Hyperbaric Bupivacaine (0.5%) on the onset & duration of sensory and motor block and to evaluate perioperative hemodynamic effects |
Immediately after induction till 180 minutes. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the post-operative analgesia.
To evaluate the occurrence of side effects & complications, if any.
|
Immediately after induction till 180 minutes. |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
30/07/2023 |
| 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="4"
Days="1" |
|
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
|
Subarachnoid block has been a popular anesthesia technique
for infra-umbilical and lower limb surgeries. Hyperbaric racemic bupivacaine is
commonly used for subarachnoid due to its long duration of action and combined
motor and sensory blockade. However, the use of hyperbaric racemic bupivacaine
in subarachnoid block has some drawbacks. It has a high propensity to cause
hypotension and bradycardia following intrathecal injection, and there is
potential for catastrophic cardiac toxicity due to the high affinity of
bupivacaine to cardiac myocytes. Levobupivacaine, an amide local anesthetic
which is the isolated S-enantiomer of bupivacaine.
Racemic bupivacaine is an equimolar mixture of dextro and
levobupivacaine. Levobupivacaine has a lower affinity for cardiac sodium
channels and greater plasma protein binding affinity compared with the dextro
isomer; thus, reducing the risk of cardio-toxicity.
Levobupivacaine also results in earlier motor recovery compared with
racemic bupivacaine. These advantages make levobupivacaine an attractive
alternative to racemic bupivacaine for sub arachnoid block. However its
clinical efficacy in subarachnoid block should be known first. |