| CTRI Number |
CTRI/2022/03/040896 [Registered on: 08/03/2022] Trial Registered Prospectively |
| Last Modified On: |
07/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare analgesic effect of two different doses of intrathecal nalbuphine (0.8 mg versus 1.6mg) as an adjuvant to 0.75% isobaric ropivacaine along with control group for elective lower limb surgeries |
|
Scientific Title of Study
|
Analgesic effect of intrathecal two different doses of nalbuphine 0.8mg versus 1.6 mg as an adjuvant to 0.75% isobaric ropivacaine for elective lower limb surgeries: a randomized double blind controlled interventional study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sunita Meena |
| Designation |
Associate Professor |
| Affiliation |
Sawai Man Singh medical college and atttached hospitals |
| Address |
Department of Anaesthesiology,Sawai Man Singh medical college and atttached hospitals,Adarsh Nagar jaipur.
Jaipur
RAJASTHAN
302004
India |
| Phone |
9461290011 |
| Fax |
|
| Email |
sunitameena98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunita Meena |
| Designation |
Associate Professor |
| Affiliation |
Sawai Man Singh medical college and atttached hospitals |
| Address |
Department of Anaesthesiology,Sawai Man Singh medical college and atttached hospitals,Adarsh Nagar jaipur.
Jaipur
RAJASTHAN
302004
India |
| Phone |
9461290011 |
| Fax |
|
| Email |
sunitameena98@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Navdeep Chohan |
| Designation |
junior resident |
| Affiliation |
Sawai Man Singh medical college and atttached hospital |
| Address |
Department of Anaesthesiology,Sawai Man Singh medical college and atttached hospitals,Adarsh Nagar jaipur.
Jaipur
RAJASTHAN
302004
India |
| Phone |
9855213337 |
| Fax |
|
| Email |
navychohan15@gmail.com |
|
|
Source of Monetary or Material Support
|
| department of anaesthesiology,Sawai Man Singh medical college and atttached hospital |
|
|
Primary Sponsor
|
| Name |
Sawai Man Singh medical college and atttached hospital |
| Address |
JLN Marg,Adarsh Nagar,Jaipur. |
| Type of Sponsor |
Government 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 |
| Navdeep Chohan |
SMS Medical college and hospital |
Department of Anaesthesiology ,Dhanvantri building,1st floor,Adarsh Nagar ,jaipur
Jaipur
RAJASTHAN |
9855213337
navychohan15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMS Medical College and Attached Hospitals, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M849||Disorder of continuity of bone, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
injection 0.75% isobaric ropivacaine 15mg |
Intrathecal 2ml of 0 .75% isobaric ropivacaine + 0.5ml normal saline (Total volume 2.5 ml). |
| Comparator Agent |
injection nalbuphine 0.8mg |
Intrathecal 2ml of 0.75% isobaric ropivacaine + 0.8mg nalbuphine made up to 0.5 ml volume with normal saline (Total volume 2.5 ml). |
| Comparator Agent |
injection nalbuphine 1.6mg |
Intrathecal 2ml of 0.75% isobaric ropivacaine + 1.6 mg nalbuphine made up to 0.5 ml volume with normal saline (Total volume 2.5 ml). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient of either sex.
Age group between 18 to 60 years.
Weight of the patient between 40-70 kilograms.
Height of the patient ≥ 145cm.
Patients belonging to ASA class I and II.
Patients undergoing elective lower limb surgery. |
|
| ExclusionCriteria |
| Details |
Patient’s refusal for spinal anaesthesia.
Uncooperative patients.
Patients not willing to participate in the study.
Patients with compromised airway or morbid obesity.
Patients with contraindications for spinal anesthesia.
History of convulsion, allergy to the drug used, bleeding disorder, severe neurological deficit.
Patients with history of hypertension, diabetes mallietus, respiratory, cardiac, hepatic or renal disease (necessitating classification in ASA Class III or above).
Pregnant patients.
Patient receiving phenothiazine, hypnotics or other central nervous system depressants.
•Patients in which spinal anesthesia failed. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To access and compare the time duration for need of first rescue dose of analgesic among three groups |
At every 2 minutes for initial 10 minutes, 5 minutes for 10-30 minutes then every 10 minutes till surgery ends and then every 30 minutes for 6 hours after giving subarachnoid block. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To find out the difference in mean onset time & duration of sensory & motor block between the three groups.
2.To assess & compare hemodynamic parameters (heart rate, mean blood pressure, systolic blood pressure & diastolic blood pressure), sedation score and post-operative visual analogue scale score.
3.To find out & compare the proportion of cases with side effects and complications |
At every 2 minutes for initial 10 minutes, 5 minutes for 10-30 minutes then every 10 minutes till surgery ends and then every 30 minutes for 6 hours after giving subarachnoid block. |
|
|
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)
|
14/03/2022 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
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
|
By studying and comparing the analgesic effect of above mentioned doses of intrathecal nalbuphine as an adjuvant to 0.75% isobaric ropivacaine along with control group in elective lower limb surgeries will help us to be more efficient in providing best anaesthesia possible to the patient and open up to more research projects. |