| CTRI Number |
CTRI/2019/01/017093 [Registered on: 15/01/2019] Trial Registered Prospectively |
| Last Modified On: |
11/01/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of effect of Isobaric levobupivacaine – fentanyl and Isobaric levobupivacaine – buprenorphine in lower limb surgeries when given intrathecally. |
|
Scientific Title of Study
|
Comparison of effect of intrathecal Isobaric levobupivacaine – fentanyl and Isobaric levobupivacaine – buprenorphine in lower limb surgeries. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PREET FURIA |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
MGM MEDICAL COLLEGE AND HOSPITAL, AURANGABAD |
| Address |
MGM Medical College and Hospital, Departmment of Anaesthesia , 5th floor
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9920837720 |
| Fax |
|
| Email |
preet.tiger@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vasanti Sasturkar Kelkar |
| Designation |
Head Of Department |
| Affiliation |
MGM MEDICAL COLLEGE AND HOSPITAL, AURANGABAD |
| Address |
MGM Medical College and Hospital , Department of Anaesthesia , 5th floor
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
93720668196 |
| Fax |
|
| Email |
vasantikelkar70@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PREET FURIA |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
MGM MEDICAL COLLEGE AND HOSPITAL, AURANGABAD |
| Address |
MGM Medical College and Hospital, Departmment of Anaesthesia , 5th floor
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9920837720 |
| Fax |
|
| Email |
preet.tiger@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM Institute Of Health Sciences , N-6 CIDCO , Aurangabad - 431003 |
|
|
Primary Sponsor
|
| Name |
MGM INSTITUTE OF HEALTH SCIENCES |
| Address |
MGM Medical College And Hospital, N-6 CIDCO, Aurangabad - 431003 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| MGM INSTITUTE OF HEALTH SCIENCES |
MGM MEDICAL COLLEGE AND HOSPITAL, N-6 CIDCO, AURANGABAD - 431003 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| PREET FURIA |
MGM Medical College and Hospital , Aurangabad |
MGM Medical College and Hospital , Department of Anaesthesia , 5th floor
Aurangabad
MAHARASHTRA |
9920837720
preet.tiger@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MGM-ETHICS COMMITTEE FOR RESEARCH ON HUMAN SUBJECTS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients Undergoing Lower Limb Surgeries Like Fractures , Skin Grafting , Ammputation ETC |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Buprenorphine |
Intrathecal Dosage - 60 Micrograms
Assess Sensory And Motor Block At
0 Mins
3 Mins
6 Mins
9 Mins
12 Mins
15 Mins
18 Mins
20 Mins
30 Mins
40 Mins
50 Mins
60 Mins
70 Mins
80 Mins
90 Mins
100 Mins
110 Mins
120 Mins
130 Mins
140 Mins
150 Mins
160 Mins
170 Mins
180 Mins
190 Mins
200 Mins
210 Mins
220 Mins
230 Mins
240 Mins |
| Intervention |
Comparison of effect of Intrathecal Isobaric Levobupicaine - Fentanyl And Isobaric Levobupivacaine - Buprenorphine in Lower Limb Surgeries. |
This Study is to be done to compare the effect of combination of Intrathecal Isobaric Levobupivacaine - Fentanyl and Isobaric Levobupivacaine - Buprenorphine in lower limb Surgeries in terms of Sensory and motor blockade over 60 patients. |
| Comparator Agent |
FENTANYL |
INTRATHECAL DOSAGE - 60 MICROGRAMS
ASSESS SENSORY AND MOTOR BLOCKADE AT
0 Mins
3 Mins
6 Mins
9 Mins
12 Mins
15 Mins
18 Mins
20 Mins
30 Mins
40 Mins
50 Mins
60 Mins
70 Mins
80 Mins
90 Mins
100 Mins
110 Mins
120 Mins
130 Mins
140 Mins
150 Mins
160 Mins
170 Mins
180 Mins
190 Mins
200 Mins
210 Mins
220 Mins
230 Mins
240 Mins
|
| Comparator Agent |
Isobaric Levobupivacaine |
Intrathecal Dosege - 3 ml to assess sensory and motor blockade at
0 Mins
3 Mins
6 Mins
9 Mins
12 Mins
15 Mins
18 Mins
20 Mins
30 Mins
40 Mins
50 Mins
60 Mins
70 Mins
80 Mins
90 Mins
100 Mins
110 Mins
120 Mins
130 Mins
140 Mins
150 Mins
160 Mins
170 Mins
180 Mins
190 Mins
200 Mins
210 Mins
220 Mins
230 Mins
240 Mins
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age group between 18 to 65 years
Sex- Male/Female
ASA Grade 1, 2, 3
Lower limb surgeries (both Orthopaedic and general surgery)
Height between 140 cm to 180 cm
|
|
| ExclusionCriteria |
| Details |
Contraindications of spinal anaesthesia such as: Local infection, Raised intra cranial tension, Coagulopathy, Valvular heart disease.
Known allergies to the study drugs
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
Time of onset of sensory block.
Maximum height of sensory block.
Duration of sensory block as regression to L1
Time of onset of motor block.
Duration of motor block.
Duration of post operative analgesia |
6 Hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Duration of post operative analgesia
Intra operative changes in heart rate and mean blood pressure.
Side effects such as nausea vomiting, pruritus and respiratory depression
|
6 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 4 |
|
Date of First Enrollment (India)
|
01/02/2019 |
| 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="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)?
|
|
Brief Summary
|
To compare the
effects of intrathecal isobaric levobupivacaine – fentanyl and isobaric levobupivacaine
– buprenorphine for spinal anaesthesia in lower limbsurgeries with regards to spinal
block characteristics, post operative analgesia and intraoperative haemodynamic
stability.
The following parameters are to be studied in each group.
·
Time
of onset of sensory block.
·
Maximum
height of sensory block.
·
Duration
of sensory block as regression to L1
·
Time
of onset of motor block.
·
Duration
of motor block.
·
Duration
of post operative analgesia
·
Intra
operative changes in heart rate and mean blood pressure.
·
Side
effects such as nausea vomiting, pruritus and respiratory depression
To compare
all the above parameter in both the groups.
|