| CTRI Number |
CTRI/2022/03/040877 [Registered on: 07/03/2022] Trial Registered Prospectively |
| Last Modified On: |
27/02/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing effects of levo bupivacaine in two different concentration, in spinal anaesthesia. |
|
Scientific Title of Study
|
"A prospective,randomized,double blind study comparing intrathecal hyperbaric levo bupivacaine with plain levo bupivacaine in infra umblical surgeries" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jasmine Kumar |
| Designation |
Clinical Assistant |
| Affiliation |
Sir Gangaram Hospital |
| Address |
Institute of Anaesthesia , Pain and Perioperative Medicine, SSRB 5th Floor,Sir Gangaram Hospital,
Old Rajinder Nagar, New Delhi, Delhi
Institute of Anaesthesia , Pain and Perioperative Medicine, SSRB 5th Floor,Sir Gangaram Hospital,
Old Rajinder Nagar, New Delhi, Delhi
Central
DELHI
110060
India |
| Phone |
9650799091 |
| Fax |
|
| Email |
drjkumar3111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jasmine Kumar |
| Designation |
Clinical Assistant, Anaesthesiology |
| Affiliation |
Sir Gangaram Hospital |
| Address |
Institute of Anaesthesia , Pain and Perioperative Medicine, SSRB 5th Floor,Sir Gangaram Hospital,
Old Rajinder Nagar, New Delhi, Delhi
Institute of Anaesthesia , Pain and Perioperative Medicine, SSRB 5th Floor,Sir Gangaram Hospital,
Old Rajinder Nagar, New Delhi, Delhi
Central
DELHI
110060
India |
| Phone |
9650799091 |
| Fax |
|
| Email |
drjkumar3111@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jasmine Kumar |
| Designation |
Clinical Assistant |
| Affiliation |
Sir Gangaram Hospital |
| Address |
Institute of Anaesthesia , Pain and Perioperative Medicine, SSRB 5th Floor,Sir Gangaram Hospital,
Old Rajinder Nagar, New Delhi, Delhi
Institute of Anaesthesia , Pain and Perioperative Medicine, SSRB 5th Floor,Sir Gangaram Hospital,
Old Rajinder Nagar, New Delhi, Delhi
Central
DELHI
110060
India |
| Phone |
9650799091 |
| Fax |
|
| Email |
drjkumar3111@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Anaesthesia , Pain and Perioperative Medicine, SSRB 5th Floor,Sir Gangaram Hospital,
Old Rajinder Nagar, New Delhi, Delhi |
|
|
Primary Sponsor
|
| Name |
Sir Gangaram Hospital |
| Address |
Old Rajinder Nagar, New Delhi, 110060 |
| 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 |
| DrJasmine Kumar |
Sir Gangaram Hospital, India |
Institute of Anaesthesia , Pain and Perioperative Medicine, SSRB 5th Floor,Old Rajinder Nagar, New Delhi, 110060
Central
DELHI |
9650799091
drjkumar3111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sir Gangaram Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparator agent will be hyperbaric levobupivacaine made by adding dextrose to isobaric levobupivacaine.The duration of the study will be till the patient will be in post anaesthesia care unit / PACU. |
Spinal anaesthesia will be given to patients.The frequency of drug- it will be given only once to the patient, at the beginning of induction of anaesthesia.The duration of therapy will be only till the patient will be in the post anaesthesia care unit / PACU or 3 hours.Either isobaric or hyperbaric levobupivacaine will be administered to patients.Isobaric levobupivacaine will be prepared by adding saline to levobupivacaine. The effect of the drugs will be studied regarding sensory block, motor block and their wearing effects.The duration of the study will be till the patient will be in post anaesthesia care unit / PACU. |
| Intervention |
Intervention will be spinal anaesthesia. Comparator will be hyperbaric levobupivacaine.It will be given to patients via spinal anaesthesia. The effects of hyperbaric form of drug will be compared with isobaric form. The duration of the study will be till the patient will be in post anaesthesia care unit / PACU. |
Subarachnoid block will be given in patients. The frequency of drug will be given only once, at the beginning of induction of anaesthesia.The duration of the therapy will be only till the patient will be in the post anaesthesia care unit / PACU or 3 hours. The comparator agent will be hyperbaric levobupivacaine. It will be prepared by adding dextrose to levobupivacaine to make it hyperbaric. The effect of this will be compared with isobaric levobupivacaine. The effect of both the drugs will be compared and studied regarding sensory block, motor block and their wearing off effects.The duration of study will be till the patients are in post anaesthesia care unit / PACU. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients of either gender aged 18-60 years
ASA 1-ASA 3 patients
Infraumblical surgeries under spinal anaesthesia |
|
| ExclusionCriteria |
| Details |
Past history of spine surgery
Infective focus at site of injection
Coagulopathy
Obesity BMI> 30
Short height< 150 cm
Unwilling patients
Pregnancy
Lower limb paresis
History of arrhythmias |
|
|
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 |
| Time to obtain maximum sensory block.The highest level of sensory block.Two segment regression of sensory block.The degree of maximum motor block.The end time of motor block. |
Onset, every 5 minutes ,every 15 minutes, 1 hour,2 hours , 3 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Heart rate changes
Peripheral oxygen saturation changes |
From time of spinal anaesthesia to patient in PACU |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
26/03/2022 |
| 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="20" |
|
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 anaesthesia is a common and established technique for providing anaesthesia for infraumblical surgeries, i.e. surgeries below naval like haemorrhoidectomy, inguinal herniorrhaphy, transurethral retropubic prostatectomy, caesarean section or surgeries on lower limbs like debridement and amputation. In this type of anaesthesia patient is awake, does not go to sleep.It has its own benifits. The patient can be discharged from hospital on the same day.That will help the patient from extra expences and long stay in hospital.Spinal block is safe, effective and easy to perform technique.Spinal anaesthesia requires smaller dose of local anaesthetics and produces intense blockade. Levobupivacaine is an isomer, S[-] enantiomer of bupivacaine. It is less cardiotoxic and neurotoxic than bupivacaine which is commonly used in spinal anaesthesia. We intend to study the effects of hyperbaric levobupivacaine and plain levobupivacaine in spinal anaesthesia in patients . It has better safety profile than bupivacaine and hence a better choice if drug. |