| CTRI Number |
CTRI/2020/04/024823 [Registered on: 23/04/2020] Trial Registered Prospectively |
| Last Modified On: |
16/04/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Comfort with spinal anaesthesia |
|
Scientific Title of Study
|
Comparative study of intrathecal Nalbuphine and intrathecal Fentanyl as adjuvant to 0.5% hyperbaric Bupivacaine in abdominal and 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 |
Dr U S S A Varaprasad |
| Designation |
professor and hod |
| Affiliation |
DR.PSIMS&RF |
| Address |
Department of anesthesiology
Dr pinnamaneni Siddhartha institute of medical sciences
Chinaovutupally
Gannavaram
Krishna
ANDHRA PRADESH
521286
India |
| Phone |
9849725560 |
| Fax |
|
| Email |
doctorvaraprasad@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr U S S A Varaprasad |
| Designation |
professor and hod |
| Affiliation |
DR.PSIMS&RF |
| Address |
Department of anesthesiology
Dr pinnamaneni Siddhartha institute of medical sciences
Chinaovutupally
Gannavaram
Krishna
ANDHRA PRADESH
521286
India |
| Phone |
9849725560 |
| Fax |
|
| Email |
doctorvaraprasad@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Karupothu Rani |
| Designation |
1st year resident |
| Affiliation |
DR.PSIMS&RF |
| Address |
Department of anesthesiology
Dr pinnamaneni Siddhartha institute of medical sciences
Chinaovutupally
Gannavaram
Krishna
ANDHRA PRADESH
521286
India |
| Phone |
9652768826 |
| Fax |
|
| Email |
rani02.k@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Pinnamaneni Siddartha Institute Of Medical Sciences
Chinavutupally
Gannavaram |
|
|
Primary Sponsor
|
| Name |
DRPSIMS RF |
| Address |
Dr. Pinnamaneni siddartha institute of medical sciences & Research foundation
Chinaoutpally
Gannavaram
|
| 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 |
| DR U S S A Varaprasad |
Dr.PSIMS and RF |
Depatment of anaesthesia and critical care
second floor OT
Dr pinnamaneni Siddhartha institute of medical sciences, chinaovutupally, gannavaram
Krishna
ANDHRA PRADESH |
9849725560
doctorvaraprasad@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR PSIMS AND RF IEC Human studies |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Adjuvants in spinal anaesthesia |
O.5mg Nalbuphine and 25 micrograms Fentanyl will be added to 0.5% Bupivacaine in spinal anaesthesia and postoperative analgesia duration ,haemodynamics will be noted |
| Comparator Agent |
Fentanyl 25 micrograms
Nalbuphine 0.5mg |
O.5mg Nalbuphine and 25 micrograms Fentanyl will be added to 0.5% Bupivacaine in spinal anaesthesia and postoperative analgesia duration, haemodynamics will be noted |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade 1 and 2 patients
Age group of 18-60 years
patient willing to give consent
patient undergoing abdominal and lower limb surgeries |
|
| ExclusionCriteria |
| Details |
patient allergic to any anaesthetic drug
bleeding disorders
ASA grade 3 and 4
patient. not willing for consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study duration of postoperative analgesia ,haemodynamics and side effects of Nalbuphine and Fentanyl |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
20/05/2020 |
| 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="1"
Months="6"
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)?
|
|
Brief Summary
|
Spinal anaesthesia is the most popular regional anaesthesia technique.Pain is one of the primary concerns after surgery .Many drugs have been used intrathecally as an adjuvant to local anaesthetics to prolong post operative pain relief .Use of intrathecal opioids as adjuncts has a definite place in the present regional anaesthesia practice.Intrathecal opioids are synergistic with local anaesthetics and prolong the duration of postoperative analgesia.Drugs like Morphine,Fentanyl have been used but they have their own side effects. Nalbuphine is an opioid agonist-antagonist recently introduced. It has lesser side effetcs compared to others .There are very few studies comparing N albuphine and Fentanyl .Hence an attempt is being made to comnpare the efficacy of Nalbuphine and Fentanyl in postoperative analgesia and haemodynamics |