| CTRI Number |
CTRI/2022/11/047664 [Registered on: 25/11/2022] Trial Registered Prospectively |
| Last Modified On: |
22/11/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Which local anesthetic drug is ideal for spinal anesthesia for short duration surgeries like inguinal hernia surgery ?0.5% isobaric Levobupivacaine or 0.5% isobaric Ropivacine? |
|
Scientific Title of Study
|
Comparative study of Intra thecal 0.5% isobaric Ropivacaine versus 0.5% isobaric Levo bupivacaine in unilateral hernia 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 FIFINA K K |
| Designation |
SENIOR RESIDENT |
| Affiliation |
MALABAR MEDICAL COLLEGE AND RESEARCH CENTRE |
| Address |
Department of anaesthesiology
Malabar medical college and research centre
Ulliyeri
Calicut
KERALA
Kozhikode
KERALA
673323
India |
| Phone |
9539442824 |
| Fax |
|
| Email |
fifna.latheef@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR RAMAKRISHNA PAI JAKRIBETTU |
| Designation |
HOD DEPARTMENT OF MICROBIOLOGY |
| Affiliation |
MALABAR MEDICAL COLLEGE AND RESEARCH CENTRE |
| Address |
DEPARTMENT OF MICROBIOLOGY
MALABAR MEDICAL COLLEGE AND RESEARCH CENTRE
ULLIYERI
Kozhikode
KERALA
673323
India |
| Phone |
9986415211 |
| Fax |
|
| Email |
scientificcommittee@mmchospital.in |
|
Details of Contact Person
Public Query
|
| Name |
DR PAUL O RAPHAEL |
| Designation |
HOD DEPARTMENT OF ANAESTHESIOLOGY |
| Affiliation |
MALABAR MEDICAL COLLEGE AND RESEARCH CENTRE |
| Address |
DEPARTMENT OF ANAESTHESILOGY
MALABAR MEDICAL COLLEGE AND RESEARCH CENTRE
ULLIYERI
Kozhikode
KERALA
673323
India |
| Phone |
8281804916 |
| Fax |
|
| Email |
poloralph1965@gmail.com |
|
|
Source of Monetary or Material Support
|
| MALABAR MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER |
|
|
Primary Sponsor
|
| Name |
MALBAR MEDICAL COLLEGE |
| Address |
MALABAR MEDICAL COLLEGE AND RESEARCH INSTITUTE
ULLIYERI CALICUT KERALA INDIA 673323 |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR FIFINA K K |
MALABAR MEDICAL COLLEGE HOSPITALAND RESEARCH CENTRE |
DEPARTMENT OF ANAESTHESIOLOGY
3RD FLOOR,MALABAR MEDICAL COLLEGE HOSPITAL AND REAEARCH CENTRE,ULLIYERI,CALICUT,KERALA,INDIA,673323
Kozhikode
KERALA |
9539442824
fifna.latheef@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE MALABAR MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, (2) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ropivcaine |
Patients undergoing unilateral hernia surgeries under spinal anaesthesia. Group B received 0.5% ropivacaine 3ml intrathecally under aseptic precaution. After injecting the drug patients will be monitored for heart rate, blood pressure, onset and duration of sensory and motor blockade. Parameters studied in the intraoperative period include sensory block, motor block, and block height and the postoperative period includes time for regression to L1, sensory recovery, motor recovery and time for complete regression. Blood pressure and Heart rate will be checked every one min after giving spinal anaesthesia, for 10 min and every 5 min for next 1 hr and then every 15 min until the end of surgery. Sensory and motor blockade will be assessed every 3 min for 15 min, every 10 min for 45 minutes, every 15 min for 90 min and finally 30 min thereafter until sensory block regress to S2 dermatome. Sensory blockade will be assessed from caudal to cephalad end in mid axillary line by needle prick sensation. Motor blockade will be assessed by using modified Bromage scale.
Patient will be monitored until regression of sensory and motor blockade. |
| Intervention |
Levobupivacaine |
Patients undergoing unilateral
inguinal hernia surgeries under spinal anaesthesia.
Group A patients received 0.5% isobaric levobupivacaine 3ml intrathecally under aseptic precaution. After injecting the drug patient will be monitored for heart rate, blood pressure, onset and duration of sensory and motor blockade.
Parameters studied in the intraoperative period include sensory block, motor block and block height and the post-operative period includes time for regression to L1, sensory recovery, motor recovery and time for complete regression. Blood pressure and heart rate will be checked every one minute after giving spinal anaesthesia , for 10 min and every 5 min for next 1 hr and then every 15 min until the end of surgery.Sensory and motor blockade will be assessed every 3 min for 15 min, every 10 min for 45 minutes, every 15 min for 90 min and finally 30 min thereafter until sensory block regress to S2 dermatome. Sensory blockade will be assessed from caudal to cephalad end in mid axillary line by needle prick sensation.Motor blockade will be assessed by using modified Bromage scale.
Patient will be monitored until regression of sensory and motor blockade. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA 1 & 2 patients
2.Scheduled for unilateral inguinal hernia surgeries |
|
| ExclusionCriteria |
| Details |
1.Patients not willing to participate in the study
2. Contra indications to spinal anaesthesia ( INR>1.3, platelet count <75000)
3. ASA 3,4 patients
4. Neurological diseases like multiple sclerosis, lumbar disc herniation etc...
5. Allergy to local anaesthetics |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare duration of motor and sensory blockade of intrathecal 0.5% isobaric levobupivacaine with 0.5% isobaric ropivacaine |
After giving spinal blood pressure and heart rate will be checked every one minute for 10 mins and every 5 mins for next 1 hour and then every 15 mins until the end of the surgery.Sensory and motor blockade will be assessed every 3 min for 15 min and every 10 min for 45 min,every 15 min for 90 min and finally 30 min thereafter until sensory block regress to S2 dermatome. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
1.onset of action
2.time to maximum sensory and motor blockade
3.haemodynamic parameters between intrathecal 0.5% isobaric levo bupivacaine and 0.5% isobaric ropivacaine |
After giving spinal blood pressure and heart rate will be checked every one minute for 10 mins and every 5 mins for next 1 hour and then every 15 mins until the end of the surgery.Sensory and motor blockade will be assessed every 3 min for 15 min and every 10 min for 45 min,every 15 min for 90 min and finally 30 min thereafter until sensory block regress to S2 dermatome. |
|
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Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
01/12/2022 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
A comparative study of intrathecal 0.5% levobupivacaine versus 0.5% ropivacaine in unilateral inguinal hernia surgeries was proposed as a study to compare duration of motor and sensory blockade as primary objective. Secondary objective being to compare the onset time to maximum sensory and motor blockade and hemodynamic parameters and our hypothesis is that levobupivacaine has prolonged duration of sensory and motor blockade which is better for prolonged surgeries and ropivacaine has shorter duration of motor blockade which is preferred for faster recovery and early ambulation and hence the latter can be administered for daycare surgeries. It is also beneficial in context of decreasing the incidence of urinary retention . |