CTRI Number |
CTRI/2023/09/057689 [Registered on: 15/09/2023] Trial Registered Prospectively |
Last Modified On: |
14/09/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Spinal Anaesthesia comparison with hyperbaric drug in lower limb surgeries |
Scientific Title of Study
|
Comparison between hyperbaric levobupivacaine with
buprenorphine and hyperbaric ropivacaine with buprenorphine
for spinal anesthesia in patients undergoing lower limb
surgery: A prospective randomised study |
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 NAVANEETHAN N K |
Designation |
Postgraduate in Department of Anaesthesiology |
Affiliation |
Rajarajeswari medical college and hospital |
Address |
Department of Anesthesiology,Rajarajeswari medical college and hospital,Kambipura,Mysore road, Bangalore
Bangalore KARNATAKA 560074 India |
Phone |
9444960258 |
Fax |
|
Email |
navaneethan.karthikeyan@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr NADIA ROSE |
Designation |
Associate Professor |
Affiliation |
Rajarajeswari medical college and hospital |
Address |
Department of Anesthesiology,Rajarajeswari medical college and hospital,Mysore road,Kambipura,Bangalore
Bangalore KARNATAKA 560074 India |
Phone |
9513454567 |
Fax |
|
Email |
dr.nadia.rose@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr NADIA ROSE |
Designation |
Associate Professor |
Affiliation |
Rajarajeswari medical college and hospital |
Address |
Department of Anesthesiology,Rajarajeswari medical college and hospital,Mysore road,Kambipura,Bangalore
Bangalore KARNATAKA 560074 India |
Phone |
9513454567 |
Fax |
|
Email |
dr.nadia.rose@gmail.com |
|
Source of Monetary or Material Support
|
Department of Anesthesiology,2nd floor,Rajarajeswari medical college and hospital,Bangalore-560074 |
|
Primary Sponsor
|
Name |
Rajarajeswari medical college and hospital |
Address |
Department of Anesthesiology,Rajarajeswari medical college and hospital,Kambipura,Mysore road,Bangalore,Karnataka-560074 |
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 NAVANEETHAN N K |
Rajarajeswari medical college and hospital |
Department of Anesthesiology,Rajarajeswari medical college and hospital,Kambipura,Mysore road,Bangalore Bangalore KARNATAKA |
9444960258
navaneethan.karthikeyan@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional ethical committee,Rajarajeswari medical college and hospital |
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 |
Spinal anesthesia with hyperbaric 0.5 % levobupivacaine with buprenorphine 60mcg |
Intrathecal administration of hyperbaric 0.5 % levobupivacaine 3ml with 60mcg buprinorphine |
Intervention |
Spinal anesthesia with hyperbaric 0.75% ropivacaine with buprenorphine 60mcg |
Intrathecal administration of hyperbaric 0.75% ropivacaine with 60 mcg buprenorphine |
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1. ASA I and II patients of either sex undergoing elective lower limb surgeries.2.Patients aged between 20 to 60 years |
|
ExclusionCriteria |
Details |
1. Patients with bradycardia.(HR less than 50)
2. Patients with known hypersensitivity to local anaesthetic drugs.
3. Pregnant and lactating women
4.Contraindication to spinal anesthesia (Patient refusal, Coagulopathy, Local infection)
5. Patients diagnosed to have neurological diseases and Musculoskeletal diseases
6. Patients with previous spine surgeries and spine abnormalities.
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
To compare onset of sensory blockade between intrathecal 0.5%(H) Levobupivacaine with Buprenorphine and 0.75%(H) Ropivacaine with Buprenorphine in Lower limb surgeries |
After giving spinal anesthesia |
|
Secondary Outcome
|
Outcome |
TimePoints |
To compare onset of motor blockade between intrathecal 0.5%(H) Levobupivacaine with Buprenorphine & 0.75%(H) Ropivacaine with Buprenorphine in Lower limb surgeries |
After giving spinal anaesthesia |
To compare duration of sensory blockade between intrathecal 0.5% (H) Levobupivacaine with buprenorphine & 0.75% (H) Ropivacaine with buprenorphine in lower limb surgeries |
During surgery |
To compare duration of analgesia between intrathecal 0.5% (H) levobupivacaine with buprenorphine & 0.75% (H) ropivacaine with buprenorphine in lower limb surgeries |
During & after surgery |
To compare hemodynamic changes between intrathecal 0.5%(H) Levobupivacaine with Buprenorphine & 0.75%(H) Ropivacaine with Buprenorphine in Lower limb surgeries |
During & after surgery |
To compare side effects between intrathecal 0.5%(H) Levobupivacaine with Buprenorphine & 0.75%(H) Ropivacaine with Buprenorphine in Lower limb surgeries |
After giving spinal anesthesia |
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
25/09/2023 |
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="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
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
|
Spinal Anaesthesia is a safe and effective form of anaesthesia widely used in anaesthetic practise as an alternative to general anaesthesia in surgeries that involve lower extremities and infraumbilical region. It provides good anaesthesia,analgesia,motor,sensory blockade but bradycardia and hypotension are its most common side effects. Local anaesthetic bupivacaine is the most commonly used agent at present but it has high cardiac and central nervous system toxicity compared to other agents.1 Levobupivacaine which is an S (-)- enantiomer of bupivacaine is long acting local anesthetic which has with high potency.1 It has less cardiotoxic and central nervous system effects in comparison with both R(+) bupivacaine and bupivacaine. Several studies have been conducted to compare Bupivacaine and Levobupivacaine in various forms and it has been shown that Levobupivacaine has efficacy similar to Bupivacaine with higher safety profile.2,3 Ropivacaine an amino amide local anaesthetic , is the S-Enantiomer of a bupivacaine, which has low cardiac toxicity as well as CNS toxicity.It has been found to be less potent than Bupivacaine and Levobupivacaine.1 Buprenorphine is an agonist-antagonist opioid which acts as an antagonist at kappa receptor and partial agonist at µ receptor. It has been studied as adjuvant in spinal anesthesia.Opioid adjuvants in spinal anesthesia has been shown to enhance to quality of anesthesia and analgesia.4 Need for study-After extensive search of literature we found that not many studies has been done in comparing in equipotent doses of levobupivacaine and ropivacaine in spinal anesthesia,hence we are doing this study to compare the same, more over due to better safety profile levobupivacaine has good prospects in replacing in bupivacaine as a drug of choice for spinal anesthesia.1 |