| CTRI Number |
CTRI/2021/09/036980 [Registered on: 30/09/2021] Trial Registered Prospectively |
| Last Modified On: |
29/09/2021 |
| 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
|
Study of two different drug effect in spinal anesthesia |
|
Scientific Title of Study
|
A comparative study of Nalbuphine and Fentanyl as adjuvant to Bupivacaine in spinal anesthesia in Lower limb orthopedic surgeries. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Khushbu Mukeshkumar Parekh |
| Designation |
post graduate resident |
| Affiliation |
Mahatma gandhi medical college and hospital |
| Address |
Departmemt of anaesthesia,Critical care & Pain management,Mahatma gandhi hospital and medical college,Jaipur
Ashish hights flats,sitapura jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
9428433390 |
| Fax |
|
| Email |
khushbuparekh770@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudhir Sachdeva |
| Designation |
Proffesor |
| Affiliation |
Mahatma gandhi medical college and hospital |
| Address |
Department of Anesthesiology, Critical care and Pain management,Mahatma Gandhi Medical College and Hospital,Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
9829055666 |
| Fax |
|
| Email |
drsudhirmgmch@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Khushbu Mukeshkumar Parekh |
| Designation |
post graduate resident |
| Affiliation |
Mahatma gandhi medical college and hospital |
| Address |
Department of anestesiology,Critical care and Pain management,Sitapura
Department of anesthesiology,sitapura
Jaipur
RAJASTHAN
302022
India |
| Phone |
9428433390 |
| Fax |
|
| Email |
khushbuparekh770@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anesthesia,Mahatma Gandhi Medical college and Hospital,Jaipur |
|
|
Primary Sponsor
|
| Name |
Mahatma gandhi medical college and hospital |
| Address |
Mahatma gandhi medical college and hospital Sitapura jaipur |
| 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 Khushbu parekh |
mahatma gandhi medical college and hospital |
Department of anesthesiology, Critical care & Pain management
Jaipur
RAJASTHAN |
9428433390
khushbuparekh770@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics comittiee MGMCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z018||Encounter for other specified special examinations, (2) ICD-10 Condition: M972||Periprosthetic fracture around internal prosthetic ankle joint, (3) ICD-10 Condition: M970||Periprosthetic fracture around internal prosthetic hip joint, (4) ICD-10 Condition: M971||Periprosthetic fracture around internal prosthetic knee joint, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Fentanyl as adjuvant to Bupivacaine |
25mcg Fentanyl as adjuvant to 0.5% 3ml Bupivacaine in intrathecal route for single time and will observe the characteristic of block during operation hours. |
| Comparator Agent |
Nalbuphine as adjuvant to Bupivacaine. |
800 mcg Nalbuphine as adjuvant to 0.5% 3ml bupivacaine in intrathecal route for single time and observe the characteristic of block during operation hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients withASAclass1/2
lower limb surgeries
patient giving written and informed consent |
|
| ExclusionCriteria |
| Details |
Patient refusal
patient with bledding diasthesis,allergic to study drug,neurological disease, spinal deformity, septicemia
Patient with local infection at injection site |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)The characteristic of sensory and motor block
2)Comparision of hemodynamic parameter and sedation score |
1)watch for need of post-operative analgesia up to 24 hours
2)Watch for regression of sensory block up to T10 for 135 min
2) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Time of first rescue analgesia
2) Patient satisfaction and adverse effect |
up to 12 hours. |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
01/10/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/10/2021 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
comparision of Nalbuphine and fentanyl as adjuvant to bupivacaine in spinal anaesthesia |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
we compare effect of fentanyl and nalbuphine as adjuvant to bupivacaine in spinal anaesthesia in lower limb orthopedic surgeries. we compare onset of sensory block , maximum dermatomal block height, onset of complete motor block. we also compare time of first rescue analgesia , patient satisfaction. |