| CTRI Number |
CTRI/2021/11/037887 [Registered on: 10/11/2021] Trial Registered Prospectively |
| Last Modified On: |
08/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
THE EFFICACY AND SAFTEY OF AN INJECTION NAMED NEFOPAM HYDROCHLORIDE FOR PAIN RELIEF AFTER UNDERGOING LOWERLIMB SURGERIES UNDER SPINAL ANAESTHESIA. |
|
Scientific Title of Study
|
THE EFFICACY AND SAFETY OF INTRAVENOUS NEFOPAM HYDROCHLORIDE AS POSTOPERATIVE ANALGESIC IN GERIATRIC PATIENTS UNDERGOING LOWER LIMB ORTHOPAEDIC SURGERIES UNDER SPINAL ANAESTHESIA. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chandu Korla |
| Designation |
POSTGRADUATE |
| Affiliation |
Jss Hospital Mysore |
| Address |
DEPT. OF ANAESTHESIOLOGY,JSS MEDICAL COLLEGE AND HOSPITAL,MG ROAD,AGRAHARA
Mysore
KARNATAKA
570004
India |
| Phone |
09966885244 |
| Fax |
|
| Email |
chandukorla193@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nalini Kotekar |
| Designation |
Professor |
| Affiliation |
JSSH Mysore |
| Address |
Professor in Department of Anesthesiology
JSS Medical College and Hospital MG Road , Agrahara
Mysore
KARNATAKA
570004
India |
| Phone |
9845112283 |
| Fax |
|
| Email |
nalinikotekar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nalini Kotekar |
| Designation |
Professor |
| Affiliation |
JSSH Mysore |
| Address |
Professor in Department of Anesthesiology
JSS Medical College and Hospital MG Road , Agrahara
Mysore
KARNATAKA
570004
India |
| Phone |
9845112283 |
| Fax |
|
| Email |
nalinikotekar@gmail.com |
|
|
Source of Monetary or Material Support
|
| JSS MEDICAL COLLEGE AND HOSPITAL, MYSURU |
|
|
Primary Sponsor
|
| Name |
JSS MEDICAL COLLEGE AND HOSPITAL |
| Address |
JSS MEDICAL COLLEGE AND HOSPITAL, MG ROAD , MYSURU |
| 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 Chandu Korla |
JSS MEDICAL COLLEGE AND HOSPITAL |
Third floor, postoperative ward, Jss hospital,MG Road,Agrahara,Mysuru.
Mysore
KARNATAKA |
9966885244
chandukorla193@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JSS MEDICAL COLLEGE AND HOSPITAL , MYSURU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: V00-Y99||External causes of morbidity, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nefopam hydrochloride |
Nefopam hydrochloride will be given as postoperative analgesic. |
| Intervention |
Nil |
20mg IV Nefopam infusion over 30 mins |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Asa 1/2
Undergoing lower limb orthopaedic surgeries under spinal anaesthesia. |
|
| ExclusionCriteria |
| Details |
Patients undergoing emergency surgeries, patients with renal and hepatic insufficiency , patients with convulsive disorders and on MAO-inhibitor drugs , patients having it’d and those with cognitive dysfunction. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate degree of pain relief and to determine duration of analgesia of Nefopam hydrochloride. |
Postoperatively when NRS score is 4 and 4th hourly till 24 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the rescue analgesic requirement , variations in hemodynamic parameters and to study adverse effects of nefopam in elderly people. |
Postoperatively when NRS score is 4 and 4th hourly till 24 hours. |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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)
|
15/11/2021 |
| 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 Yet Recruiting |
| 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
|
|
Brief Summary
|
- Following approval from institutional ethical committee, informed consent will be taken from 96 geriatric participants of American SocietyofAnaesthesiologists (ASA) Physical status 1 and 2 undergoing elective lower limb surgeries under spinal Anesthesia.
A thorough pre anaesthetic evaluation will be done 24 hours prior to the procedure.
Patients will be premeditated with Tab.Pantoprazole 40mg and Tab. Alprazolam 0.5 mg. On the morning of study, all patients will have an IV access secured before spinal anaesthesia.After connecting multi parameter monitors with ECG,pulse oximetry and non invasive blood pressure ( NIBP ), basal parameters will be recorded.Spinal anaesthesia with 25G Quinckes spinal needle using Inj.Bupivacaine 2.5 ml (0.5%) H andInj fentanyl 25 mcg will be given in sitting posture and then patient is changed to supine posture. Hemodynamic parameters - PR, BP, SPO2 will be monitored at 15 minute intervals till the end of the surgery.
After the patient is shifted to postoperative ward, NRS scores are assessed. If NRS> 4 is recorded, Inj Nefopam 20 mg in 100ml saline will be started over 30 mins. Following which PR, BP, SPO2 , RR will be monitored at 0,10,20,30 minute intervals and any adverse events will be noted. The next doses of nefopam will be given once a NRS score of 4 is recorded thereafter till 24 hours.
In spite of giving nefopam, if patients complains of pain within 24 hours of administering the drug Inj. Tramadol 50mg IV will be given at NRS more than or equal to 4. At the end of 24 hours,the total rescue analgesic requirement will be calculated.
Every time after the drug is given , degree of pain relief and duration of analgesia of nefopam hydrochloride postoperatively will be recorded along with the variations in hemodynamic parameters and adverse effects in elderly people. |