| CTRI Number |
CTRI/2022/11/047010 [Registered on: 03/11/2022] Trial Registered Prospectively |
| Last Modified On: |
02/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
comparison of hyperbaric levobupivacaine and hyperbaric ropivacaine in spinal anaesthesia for lower limb surgery |
|
Scientific Title of Study
|
Hyperbaric levobupivacaine versus
hyperbaric ropivacaine in spinal anaesthesia
for lower limb surgeries-a randomized control trial |
| Trial Acronym |
levo-ropi |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR NEEHARIKA ARORA |
| Designation |
PROFESSOR |
| Affiliation |
ROHILKHAND MEDICALCOLLEGE AND HOSPITAL |
| Address |
ROOM NO. 2062-D, AANAESTHEISA DEPARTMENT, ROHILKHAND MEDICAL COLLEGE AND HOSPITAL, PILIBHIT BYPASS ROAD, BAREILLY - 243006,
Bareilly UTTAR PRADESH 243006 India |
| Phone |
8077104070 |
| Fax |
|
| Email |
docneehars@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR NEEHARIKA ARORA |
| Designation |
PROFESSOR |
| Affiliation |
ROHILKHAND MEDICALCOLLEGE AND HOSPITAL |
| Address |
ROOM NO. 2062-D, AANAESTHEISA DEPARTMENT, ROHILKHAND MEDICAL COLLEGE AND HOSPITAL, PILIBHIT BYPASS ROAD, BAREILLY - 243006,
Bareilly UTTAR PRADESH 243006 India |
| Phone |
8077104070 |
| Fax |
|
| Email |
docneehars@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DRKAREENA POPAT |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
ROHILKHAND MEDICALCOLLEGE AND HOSPITAL |
| Address |
ROOM NUMBER 23, PG AC GIRLS HOSTEL, ROHILKHAND MEDICAL COLLEGE AND HOSPITAL, PILIBHIT BYPASS ROAD, BAREILLY- 243006
ROOM NO. 2062-D, ANAESTHEISA DEPARTMENT, ROHILKHAND MEDICAL COLLEGE AND HOSPITAL, PILIBHIT BYPASS ROAD, BAREILLY - 243006 Bareilly UTTAR PRADESH 243006 India |
| Phone |
7060899224 |
| Fax |
|
| Email |
kareenapopat@gmail.com |
|
|
Source of Monetary or Material Support
|
| ROHILKHAND MEDICAL COOLEGE AND HOSPITAL |
|
|
Primary Sponsor
|
| Name |
ROHILKHAND MEDICAL COLLEGE AND HOSPITAL |
| Address |
ROHILKHAND MEDICAL COLLEGE AND HOSPITAL, PILIBHIT BYPASS ROAD, BAREILLY - 243006 |
| Type of Sponsor |
Private 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 |
| DR NEEHARIKA ARORA |
OPERATION THEATRE, ROHILKHAND MEDICAL COLLEGE AND HOSPITAL |
DEPARTMENT OF ANAESTHESIOLOGY Bareilly UTTAR PRADESH |
8077104070
docneehars@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: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
spinal anaesthesia with hyperbaric levobupivacaine |
3 ml hyperbaric levobupivacaine 0.5% given intrathecal |
| Comparator Agent |
spinal anaethesia with hyperbaric ropivacaine |
3ml hyperbaric ropivacaine 0.75% given intrathecal |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.American society of Anaesthesiologist (ASA) grade I or II
2.BMI< 30
3.Lower limb surgeries
|
|
| ExclusionCriteria |
| Details |
1.Patients with contra-indication to Spinal anaesthesia
2.Obesity (BMI>30kg/m2)
3.Any neuropathies
4.Allergy or intolerance to Local Anaesthetics
5.Patient refusal for procedure
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Onset and duration of sensory block.
2.Onset and duration of motor block.
3.Peak height for sensory block.
4.2-segment regression time
|
The patient will be evaluated for sensory and motor block, for every 2 minutes for first 20 minutes, every 3 minutes for next 30 minutes, every 10 minutes for 60 minutes, and finally every 15 minutes until the sensory block has regressed to S1 dermatome.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Hemodynamic changes.
2.Any Side effects / Complication.
|
patient’s pulse, Systolic Blood pressure, Diastolic Blood pressure, Mean Arterial Pressure, heart rate will be recorded every 3 minutes for 30 minutes and then every 5 mins for next 30mins and then 15mins until completion of the surgery. |
|
|
Target Sample Size
|
Total Sample Size="64" Sample Size from India="64"
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)
|
07/11/2022 |
| 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="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Spinal anaesthesia has several
benefits as it provides prolonged post-operative analgesic effect, has rapid onset
and offset, easy administration, is pocket friendly, reliable, safe, patient is
awake unlike in general anaesthesia and there is decreased risk of aspiration. Earlier
hyperbaric solutions of Levobupivacaine and Ropivacaine were prepared in operating
room but now hyperbaric solutions of these drugs are available in the market in
concentration of 0.5% and 0.75% respectively each combined with 80 mg of dextrose.
The disadvantage
of preparing these hyperbaric solutions in operating room was that density of each
newly prepared solution was different, so the results could not be reproduced reliably.
Previous
studies by Casati used Levobupivacaine and Ropivacaine by adding dextrose (30mg)
in operating room and the specific gravities of the Hyperbaric Bupivacaine was 1.00874g/ml,
Hyperbaric Levobupivacaine was 1.00945g/ml and Hyperbaric Ropivacaine was 1.00876g/ml.6
This can
be compared with the newer preparations available of Hyperbaric Levobupivacaine
which has specific gravity of 1.025-1.035 and Hyperbaric Ropivacaine which has specific
gravity of 1.025-1.035. The newer preparations of both Hyperbaric Levobupivacaine
and Hyperbaric Ropivacaine contains 80mg dextrose in each ml and have similar specific
gravity.
As earlier studies on hyperbaric ropivacaine and levobupivacaine,
solutions used were prepared by addition of dextrose prior to administration,
so baricity was unreliable with specific gravity unknown. Hence, in this study, we aim to
compare the efficacy of two newly available hyperbaric preparations of hyperbaric
Levobupivacaine and hyperbaric Ropivacaine in lower limb surgeries.
Spinal Anaesthesia will be administered to the
patient in L2-L3 interspace with patient sitting using a midline approach using
25G spinal needle. According to randomization, patient will receive either preservative
free formulation of hyperbaric ropivacaine 0.75% (3ml) or hyperbaric levobupivacaine
0.5% (3ml). No adjuvant medication will be added to either local anaesthetic.
After completion of the spinal injection, patient
will be immediately made to lie supine with operating table horizontal. The patient
will be evaluated for sensory and motor block, for every 2 minutes for first 20
minutes, every 3 minutes for next 30 minutes, every 10 minutes for 60 minutes, and
finally every 15 minutes until the sensory block has regressed to S1 dermatome.
The patient will be administered Inj. Midazolam
1mg iv after spinal Anaesthesia has been given. During the surgery the patient’s
pulse, Systolic Blood pressure, Diastolic Blood pressure, Mean Arterial Pressure,
heart rate will be recorded every 3 minutes for 30 minutes and then every 5 mins
for next 30mins and then 15mins until completion of the surgery.
The sensory level of the block will be assessed
in a caudal to cephalad direction, using loss to pin prick sensation, and the C5-C6
dermatome is used as an unblocked reference point.
The motor Block will be assessed using the Modified
Bromage Scale.Readiness for surgery is defined as loss of pin
prick sensation ≥ T10 with modified Bromage≥2. During surgery, evaluation of the
motor block will be suspended until the end of the procedure. If the patient complains
of pain, Inj Butorphanol 1 mg I.V. will be administered.
If additional sedation
is needed, midazolam 1 mg I.V. will be administered. The total dose of any given
medication will be recorded. If the patient still feels pain, general anaesthesia
will be provided and the case will be excluded from the study. Any complications,
side effects and adverse effects up to 24 hours postoperatively will be noted. |