| CTRI Number |
CTRI/2019/02/017811 [Registered on: 25/02/2019] Trial Registered Prospectively |
| Last Modified On: |
14/02/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
To know which drug out of the two ( morphine and burprenorphine) used for spinal anesthesia has better pain relief in patients after surgeries of below the umblicus |
|
Scientific Title of Study
|
Comparative effects of Buprenorphine and Morphine as adjuvants to Bupivacaine spinal anesthesia in patients undergoing infra-umbilical surgeries - A Prospective study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hemamalini Arun |
| Designation |
Secondary DNB PG |
| Affiliation |
Sri Ramakrishna hospital , Coimbatore |
| Address |
Dr Hemamalini Arun ,Secondary dnb pg, dept of anaesthesiology, Sri Ramakrishna hospital, sidhapuddur, Coimbatore
Dr Hemamalini Arun , Secondary dnb pg, dept of anaesthesiology, Sri Ramakrishna hospital, Sidhapuddur, Coimbatore
Coimbatore
TAMIL NADU
641044
India |
| Phone |
9789875443 |
| Fax |
|
| Email |
dr.s.hemamalini@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prabha Udayakumar |
| Designation |
Head of Department, Anesthesiology |
| Affiliation |
Sri Ramakrishna hospital , Coimbatore |
| Address |
Dept of Anesthesiology, Sri Ramakrishna hospital, Sidhapuddur, Coimbatore
Coimbatore
TAMIL NADU
641044
India |
| Phone |
9791346959 |
| Fax |
|
| Email |
prabhadr01@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Hemamalini Arun |
| Designation |
Secondary DNB PG |
| Affiliation |
Sri Ramakrishna hospital , Coimbatore |
| Address |
Dr Hemamalini Arun, Secondary dnb pg, dept of anaesthesiology, Sri Ramakrishna hospital, sidhapuddur Coimbatore
Dr Hemamalini Arun , Secondary dnb pg, dept of anaesthesiology, Sri Ramakrishna hospital, Sidhapuddur, Coimbatore
Coimbatore
TAMIL NADU
641044
India |
| Phone |
9789875443 |
| Fax |
|
| Email |
dr.s.hemamalini@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Ramakrishna hospital, Coimbatore |
|
|
Primary Sponsor
|
| Name |
Sri Ramakrishna hospital |
| Address |
Dept of Anesthesiology, Sri Ramakrishna hospital, sidhapuddur, Coimbatore |
| 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 Hemamalini Arun |
Sri Ramakrishna hospital |
Department of anaesthesiology, old block, Sri Ramakrishna hospital, sidhapuddur, Coimbatore
Coimbatore
TAMIL NADU |
9789875443
dr.s.hemamalini@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRIRAMAKRISHNAHOSPITALETHICALCOMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G890||Central pain syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group B |
2.8ml of 0.5% heavy bupivacaine with 60 mcg buprenorphine intrathecally |
| Intervention |
Group M |
2.8ml of 0.5%heavy bupivacaine with 100 mcg of morphine intrathecal |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA Physical status 1 or 2
Presenting for infraumblical surgeries
Patients who provide consent for the study |
|
| ExclusionCriteria |
| Details |
Patient allergic to the drug
ASA Physical status 3 and above , acute or chronic respiratory disease, cognitive or psychiatric disturbances
Any contraindication to subarachnoid block
Pregnant women
Day care procedures
Patients who do not give consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the duration of postoperative analgesia of buprenorphine and morphine when given intrathecally with hyperbaric bupivacaine |
2, 4, 8, 12, 24 hours of postoperative analgesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time taken to achieve maximum sensory and motor block
Intraoperative hemodynamic changes like bradycardia and hypotension and intraoperative side effects like nausea, vomiting and pruritis |
Sensory and motor block will be assessed every 2 minutes till maximum level is reached |
|
|
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)
|
11/03/2019 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Postoperative analgesia is generally the domain of the anaesthesiologist.Intrathecal morphing has been considered as the most effective opioid because of its potency and prolonged duration of action.Buprenorphine intrathecally also provides good postoperative pain relief without prolonging motor or sensory blockade. Hence, this study is designed to compare the effects of Buprenorphine and Morphine as adjuvants to Bupivacaine spinal anesthesia in patients undergoing infraumblical surgeries. This is a prospective study involving 30 patients in each group. Group B will receive 2.8ml of 0.5% hyperbaric bupivacaine with Buprenorphine 60mcg while, Group M will receive 2.8 ml of 0.5% hyperbaric bupivacaine with 100 mcg of Morphine. Time to first rescue analgesia is the primary objective and secondary objectives include time taken to acheive maximum sensory and motor blockade, vital parameters, adverse effects perioperatively. |