CTRI Number |
CTRI/2021/07/034793 [Registered on: 13/07/2021] Trial Registered Prospectively |
Last Modified On: |
12/07/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
Public Title of Study
|
calculation of the effective dose of Levo-bupivacaine(0.5%)and Ropivacaine(0.5%) in unilateral spinal anaesthesia |
Scientific Title of Study
|
Determination of the median effective dose(ED50) of Levo-bupivacaine(0.5%)and Ropivacaine(0.5%)in unilateral spinal anaesthesia |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Mittal Patel |
Designation |
Resident Doctor in Department of Anaesthesiology |
Affiliation |
Goverment Medical College,baroda. |
Address |
Department of Anaesthesiology,Goverment Medical College and SSG Hospital,Anandpura,Vadodara,Gujarat-390001,India
Vadodara GUJARAT 390001 India |
Phone |
8401251948 |
Fax |
|
Email |
dr.mittal1808@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Mamta Patel |
Designation |
Associate professor in Department of Anaesthesiology |
Affiliation |
Goverment Medical College,baroda. |
Address |
Department of Anaesthesiology,Goverment Medical College and SSG Hospital,Anandpura,Vadodara,Gujarat-390001,India
Vadodara GUJARAT 390001 India |
Phone |
9825453024 |
Fax |
|
Email |
mgpatel111@yahoo.com |
|
Details of Contact Person Public Query
|
Name |
Dr Mamta Patel |
Designation |
Associate professor in Department of Anaesthesiology |
Affiliation |
Goverment Medical College,baroda. |
Address |
Department of Anaesthesiology,Goverment Medical College and SSG Hospital,Anandpura,Vadodara,Gujarat-390001,India
Vadodara GUJARAT 390001 India |
Phone |
9825453024 |
Fax |
|
Email |
mgpatel111@yahoo.com |
|
Source of Monetary or Material Support
|
department of anaesthesiology,new surgical block,goverment medical collage,vadodara |
|
Primary Sponsor
|
Name |
Goverment Medical College baroda |
Address |
Department of Anaesthesiology,Goverment Medical College and SSG Hospital,Anandpura,Vadodara,Gujarat 390001,India |
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 |
DrMittal patel |
ssg hospital,vadodara |
general surgery opration theatre,2nd floor,new surgical block,ssg hospital,vadodara,gujrat. Vadodara GUJARAT |
8401251948
dr.mittal1808@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional ethics committee for biomedical and health research(IECHBR) medical collage and ssg hospital,vadodara |
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 |
Intervention |
Inj Levo-Bupivacaine 0.5% given intrathecally |
The first patient in group L will be received 0.5% Levo-bupivacaine 1ml (5.0 mg)
The testing interval will be 0.5 mg. If the response of the previous patient will effective, the dose of intrathecal local anesthetic for the next patient will be decreased by 0.5 mg in that group
Conversely, if the response of the patient will be ineffective, the dose of intrathecal local anesthetic for the next patient will increase by 0.5 mg in that group.
|
Intervention |
Inj.Ropivacaine 0.5% given intrathecally |
the first patient in group R will be received 0.5% Ropivacaine1ml(5.0 mg).
The testing interval will be 0.5 mg. If the response of the previous patient will effective, the dose of intrathecal local anesthetic for the next patient will be decreased by 0.5 mg in that group.
Conversely, if the response of the patient will be ineffective, the dose of intrathecal local anesthetic for the next patient will increase by 0.5 mg in that group.
|
Comparator Agent |
Levo-bupivacaine and Ropivacaine |
Group L-Patients will be receiving Inj LevoBupivacaine 0.5% intrathecally
Group R- Patients will be receiving Inj. Ropivacaine 0.5% intrathecally |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
ASA-I/II
Elective unilateral limb(below knee) surgeries like amputation,debridement.
Height-between 5feet and 6feet |
|
ExclusionCriteria |
Details |
Patients with absolute and relative contraindications to spinal anaesthesia (Patient refusal, Local skin infection, Vertebral column abnormalities, bleeding disorders, sever hypovolemia, thyroid disorders, cardiopulmonary disease, neuropathies ,severely altered mental status)
Patients with history of diabetes, renal or hepatic disease
Patients with allergy to local anaesthetics
Pregnant and lactating females
Morbid obesity(BMI>29 kg/square metre)
|
|
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 |
-sensory and motor characteristics
-to observe any changes in hemodynamic parameters like pulse rate,blood pressure,respiratory rate,ECG,SpO2 perioperatively |
Time from administration of drug intrathecally till 24 hours |
|
Secondary Outcome
|
Outcome |
TimePoints |
to observe any complications like bradycardia,hypotention,nausea/vomiting,pruritus,shivering, urinary retention. |
Time from administration of drug intrathecally till 24 hours |
|
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
|
Phase 2 |
Date of First Enrollment (India)
|
26/07/2021 |
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="0" Months="6" Days="0" |
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report Response - Analytic Code
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dr.mittal1808@gmail.com].
- For how long will this data be available start date provided 04-03-2021 and end date provided 09-03-2022?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
Brief Summary
|
Informed Written consent: yes Anaesthesia Technique: · Patients will be thoroughly counselled during the pre-operative evaluation and will be properly explained about the procedure, and study before taking the written consent. · Patients will be kept nil by mouth for 8 hours. · In the operation Theatre, a good venous access will be secured with 18G IV cannula and all the patients will be preloaded with 8 ml/kg of Ringer’s lactate solution. Premedication: · Injection Ondansetron 4mg(0.1mg/kg)IV 5 min before induction · Injection Glycopyrrolate 0.2mg/kg (5 mcg/kg)IV5 min before induction · All baseline parameters will be observed and recorded which consist of Electrocardiography(ECG), Heart rate(HR), Non-invasive Blood Pressure(NIBP) and Pulse Oximeter(SpO2) ,Respiratory Rate before the procedure. · Basic necessities like Anaesthesia machine, monitors, resuscitation drugs, airway equipments and suction apparatus and equipment for spinal anaesthesia will be checked. The patient will be kept in lateral position with the limb to be operated on the lower side • Under all Aseptic & Antiseptic precautions spinal anesthesia will be given in L3 –L4 intervertebral space in all cases. 25G Quincke Spinal needle will be inserted. After confirmation of free CSF flow,with the bevel of the needle pointing down , study drug will be injected at the rate of 0.1ml/Second intrathecally according to Group. • Patient is made to remain in lateral position for 10 minutes.Monitoring of parameters will be started immediately on making the patient supine. • Surgery will be allowed once the peak sensory(T12) and motor blockade (Bromage 3)are achieved. • The study drug for spinal anesthesia will be prepared before anesthesia by an anesthesia assistant , who will not participate in the subsequent patient assessment. The solutions will be administered by a second attending anesthesiologist ,who will be blinded to the drug used. • If during study, there is failure of spinal anaesthesia or supplementation of general anaesthesia is required then that case will be excluded from study. DRUG PREPARATION- Group L- Inj Levo-Bupivacaine 0.5% 1ml(5mg) Group R-Inj. Ropivacaine 0.5% 1ml(5mg) The first patient in group L will be received 0.5% Levo-bupivacaine 1ml (5.0 mg) and the first patient in group R will be received 0.5% Ropivacaine1ml(5.0 mg). The testing interval in each group will be 0.5 mg. If the response of the previous patient will effective, the dose of intrathecal local anesthetic for the next patient will be decreased by 0.5 mg in that group. Conversely, if the response of the patient will be ineffective, the dose of intrathecal local anesthetic for the next patient will increase by 0.5 mg in that group. An effective outcome will be defined as a T12 sensory blockade level maintained for more than 60 min, and a Bromage score of 3 on the operation side within 10 min after injection otherwise the outcome was ineffective. The ED50 of 0.5% Levo-bupivacaine and 0.5% ropivacaine will be calculated using the Dixon and Massey formula( annexure 2) · For ensuring blinding, randomly allocated coded syringes of drugs will be prepared after taking all aseptic and antiseptic precautions by a fellow anesthesiologist not involved in performing subarachnoid block or recording of the outcome during intraoperative and postoperative periods. The Patient and theAnesthesiologist performing subarachnoid block will be blinded to the content of the drug.The content of the drug will be unblinded after 24 hours of performing subarachnoid block. | |