CTRI Number |
CTRI/2021/05/033463 [Registered on: 07/05/2021] Trial Registered Prospectively |
Last Modified On: |
06/05/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Surgical/Anesthesia |
Study Design |
Other |
Public Title of Study
|
Comparision of two adjuvant opioid drugs fentanyl and nalbuphine used for spinal anaesthesia in lower limb surgeries |
Scientific Title of Study
|
A comparative study to know the efficacy of intrathecal nalbuphine versus intrathecal fentanyl as an adjuvant to bupivacaine for 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 |
Swathi N R |
Designation |
Junior Resident in Anaesthesiology |
Affiliation |
Shri B M Patil Medical College Hospital & Research Centre |
Address |
Department of Anaesthesiology
Shri B M Patil Medical College
Bijapur
Bijapur KARNATAKA 586103 India |
Phone |
9986745669 |
Fax |
|
Email |
drswathinr@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Vijay V Katti |
Designation |
Associate professor |
Affiliation |
Shri B M Patil Medical College Hospital & Research Centre |
Address |
Department of Anaesthesiology
Shri B M Patil Medical College
Bijapur
Bijapur KARNATAKA 586103 India |
Phone |
9844585900 |
Fax |
|
Email |
drvijaykatti@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Swathi N R |
Designation |
Junior Resident in Anaesthesiology |
Affiliation |
Shri B M Patil Medical College Hospital & Research Centre |
Address |
Department of Anaesthesiology
Shri B M Patil Medical College
Bijapur
Bijapur KARNATAKA 586103 India |
Phone |
9844585900 |
Fax |
|
Email |
drswathinr@gmail.com |
|
Source of Monetary or Material Support
|
Shri B M Patil Medical College Hospital |
|
Primary Sponsor
|
Name |
Shri B M Patil Medical College |
Address |
Dept of Anaesthesiology
Shri B M Patil Medical College
Bijapur 586103 |
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 |
Swathi N R |
Shri B M Patil Medical College |
Department of Anaesthesiology,
Bijapur-586103 Bijapur KARNATAKA |
9986745669
drswathinr@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethical Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: M999||Biomechanical lesion, unspecified, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Intrathecal injection of Fentanyl AND Nalbuphine |
To study the effects of intathecal hyperbaric bupivacaine 0.5% with fentanyl versus hyperbaric bupivacaine 0.5% with nalbuphine in lower limb surgeries |
Comparator Agent |
Nalbuphine and Fentanyl |
Intrathecal route of administration.
Dose- Bupivacaine 0.5% 3 ml with Nalbuphine 1mg compared with Bupivacaine 0.5% 3ml with Fentanyl 25mcg in each group |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
Adult patients aged between 18-60 years of both sex undergoing elective lower limb surgeries.
Patients belonging to ASA Grade І and ІІ. |
|
ExclusionCriteria |
Details |
Infection at the site of injection.
Hypersensitivity to study drugs.
Coagulopathy or other bleeding diathesis.
Patients with peripheral neuropathy.
Patients with cardiac, pulmonary, hepatic or renal disorder.
Pregnancy. |
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
An Open list of random numbers |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
To compare the onset and duration of sensory and motor blockade of fentanyl and nalbuphine adjuvant to bupivacaine. |
At 0, 5, 10, 15, 30, 60 and 120 minute and time of rescue analgesia. |
|
Secondary Outcome
|
Outcome |
TimePoints |
To compare the haemodynamic changes like heart rate and blood pressure, Time of rescue analgesia and Side effects of study drugs.
|
At 0, 5, 10, 15, 30, 60 and 120 minute and time of rescue analgesia. |
|
Target Sample Size
|
Total Sample Size="70" Sample Size from India="70"
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 1/ Phase 2 |
Date of First Enrollment (India)
|
17/05/2021 |
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
|
not sent for publication |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
During preoperative visit patient’s detailed history,
general physical examination and systemic examination will be carried out.
History of any significant medical illness will be elicited. Airway,
respiratory system and cardiovascular system will be assessed.
Only ASA grade І and ІІ patients within
the age group of 18 to 60 years of either sex undergoing elective lower limb surgeries
will be included in our study. A written informed consent will be taken.
Patient
will be shifted to operation table, IV access will be obtained on forearm with
18 Gauge IV cannula and Ringer’s lactate solution 500ml will be infused intravenously
before the block. The monitors will be connected to patient which include non-invasive
blood pressure. Oxygen saturation using pulse oximeter. Baseline PR, BP and SpO2 will be recorded.
Under strict aseptic precautions, lumbar
puncture will be performed in left lateral position by midline approach by
using 26G Quincke spinal needle at L3-L4 intervertebral space and study drug
will be injected intrathecally after confirming clear free flow of CSF. Patient’s
vitals will be monitored continuously using mutli-parameter monitor. After
spinal anaesthesia, Oxygen (5L/min) by facemask will be given, Fluid therapy
will be maintained with Lactated Ringer’s solution (10ml/kg/hr).
|