| CTRI Number |
CTRI/2024/06/068884 [Registered on: 13/06/2024] Trial Registered Prospectively |
| Last Modified On: |
05/06/2024 |
| 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
|
Comparative Study Of two different drugs in Lower Abdominal And Lower Limb Surgeries |
|
Scientific Title of Study
|
Comparative Study Of Intrathecal 0.5% Bupivacaine Heavy With Nalbuphine VS 0.5% Bupivacaine Heavy Alone In Lower Abdominal And Lower Limb Surgeries |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
BINDHU R V |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
MVJ MEDICAL COLLEGE AND RESEARCH HOSPITAL |
| Address |
Dandupalya, 30th KM Milestone,
National Highway 75, Kolathur P.O.,
Hoskote Taluk
Bengaluru Rural District.
Pincode - 562 114
Department of Anaesthesiology
Room no : 2
Department of Anaesthesia
Ot Complex
Room no : 20
Kolar
KARNATAKA
562114
India |
| Phone |
9482426885 |
| Fax |
|
| Email |
drbinmanglore123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prasad Kulkarni |
| Designation |
Proffesor |
| Affiliation |
MVJ MEDICAL COLLEGE AND RESEARCH HOSPITAL |
| Address |
Dandupalya, 30th KM Milestone,
National Highway 75, Kolathur P.O.,
Kolar
KARNATAKA
562114
India |
| Phone |
09886096587 |
| Fax |
|
| Email |
prasadkulk@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
BINDHU R V |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
MVJ MEDICAL COLLEGE AND RESEARCH HOSPITAL |
| Address |
Dandupalya, 30th KM Milestone,
National Highway 75, Kolathur P.O.,
Hoskote Taluk
Bengaluru Rural District.
Pincode - 562 114
Department of anaesthesia
Room no : 2
Department of Anaesthesia
Ot complex
Room no : 20
Kolar
KARNATAKA
562114
India |
| Phone |
9482426885 |
| Fax |
|
| Email |
drbinmanglore123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mvj Medical College and Research Hospital |
|
|
Primary Sponsor
|
| Name |
MVJ MEDICAL COLLEGE AND RESEARCH HOSPITAL |
| Address |
DANDUPLAYA , 30TH KM MILESTONE KOLATHUR P.O, NH75, HOSKOTE, KARNATAKA 562114 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Bindhu R V |
MVJ Medical College and Research Hospital |
Department of Anaesthesia
ot complex
Room no : 20
Dandupalya, 30th Km Milestone Kolathur P.O, NH75, Hoskote, Karnataka 562114
Room no : 2
Department of anaesthesia
Bangalore
KARNATAKA |
9482426885
drbinmanglore123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MVJ MC & RH |
Not Applicable |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients planned for elective surgeries |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparison between intrathecal bupivacaine 0.5 % heavy with nalbuphine VS intrathecal bupivacaine 0.5% heavy |
Route : Intrathecal
Dose : 3.4ml of 0.5% Bupivacaine heavy
3.4ml of 0.5% Bupivacaine with Nalbuphine 0.8mg |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Age : 20 to 70 years
ASA Physical status of Grade I ,II and III
Patient who have valid informed and written consent
Patients undergoing lower abdominal and lower limb surgery. |
|
| ExclusionCriteria |
| Details |
Deranged coagulation profile
Pregnant Patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Intrathecal bupivacaine 0.5 % heavy with nalbuphine is better than intrathecal bupivacaine 0.5 % heavy alone |
Once in a week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To be observed |
To be observed |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
16/06/2024 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
After getting ethical clearance from ethical committee, 100 patients will be enrolled under ASA I , II , and III aged between 20-70 years scheduled for elective surgeries. written and informed consent taken . pre aneathetic evaluation willl be done.All The patients will be given anxiolytics the previous night and the next day morning of surgery. IV line with 18G cannula will be secured. The spinal anaesthesia procedure is standardized here : patient positioning is done in lateral decubitus under sterile aseptic precautions , spinal anaesthesia is performed at the L3-L4 lumbar space using a 25G Quinkes needle. Group A recieved 15mg (3ml) of 0.5% Bupivacaine(H) and nalbuphine 0.8mg (0.5ml) - total volume of 3.5ml. Grioup B recieved 15mg(3ml) of 0.5% bupivacaine (H) and normal saline 0.5ml (0.5ml) - total volume of 3.5ml. oxygen at 4litres administered through face mask. Hemodynamic parametres like peripheral oxygen saturation , non invasive blood pressure , pulse rate were recorded at regular intervals intraoperatively and post operatively upto 24hours
|