| CTRI Number |
CTRI/2024/03/063780 [Registered on: 07/03/2024] Trial Registered Prospectively |
| Last Modified On: |
03/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
PMS |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Adding additive to spinal drug to see for pain relief after surgery |
|
Scientific Title of Study
|
Comparison of the effects of Buprenorphine and Fentanyl as intrathecal adjuvant to Hyperbaric Ropivacaine 0.75% in lower abdominal surgeries:A prospective Randomised Control Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ANANYA KRISHNA T |
| Designation |
Second year Post Graduate Student |
| Affiliation |
Mysore Medical College and Research Institute |
| Address |
2nd floor Department of Anaesthesiology ,New Stone Building, Mysore Medical College and Research Institute, Irwin Road ,
Mysore, Karnataka.
2nd floor Department of Anaesthesiology ,New Stone Building, Mysore Medical College and Research Institute, Irwin Road ,
Mysore, Karnataka, 570001
Mysore
KARNATAKA
570001
India |
| Phone |
08547854885 |
| Fax |
|
| Email |
ananyakrishnat@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Lakshmipriya |
| Designation |
Assistant Professor |
| Affiliation |
Mysore Medical College and Research Institute |
| Address |
2nd floor Department of Anaesthesiology ,New Stone Building, Mysore Medical College and Research Institute, Irwin Road ,
Mysore, Karnataka.
2 nd Floor ,New Stone Building , Department of Anaesthesiology
Mysore Medical College and Research Institute ,Irwin road, Mysore , Karnataka,570001
Mysore
KARNATAKA
570001
India |
| Phone |
9845099554 |
| Fax |
|
| Email |
c7drpriya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Lakshmipriya |
| Designation |
Assistant Professor |
| Affiliation |
Mysore Medical College and Research Institute |
| Address |
2nd floor Department of Anaesthesiology ,New Stone Building, Mysore Medical College and Research Institute, Irwin Road ,
Mysore, Karnataka.
2nd floor Department of Anaesthesiology ,New Stone Building, Mysore Medical College and Research Institute, Irwin Road ,
Mysore, Karnataka,570001
Mysore
KARNATAKA
570001
India |
| Phone |
9845099554 |
| Fax |
|
| Email |
c7drpriya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mysore Medical College and Research Institute irwin road , mysore karnataka. |
|
|
Primary Sponsor
|
| Name |
Ananya Krishna T |
| Address |
1st floor department of anaesthesiology , stone building , kr hospital mysore karnataka |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| DrAnanya Krishna T |
KR Hospital |
1 st floor department of anaesthesiology stone building kr hospital Irwin road Devaraja Mohalla Yadavagiri
Mysore
KARNATAKA |
8547854885
ananyakrishnat@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE MYSORE MEDICAL COLLEGE AND RESEARCH INSTITUTE |
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 |
Group F |
Intrathecal fentanyl 0.2 ml with hyperbaric ropivacaine 0.75% for spinal anaesthesia in lower abdominal surgeries. |
| Comparator Agent |
Group G |
Intrathecal buprenorphine 0.2 ml with hyperbaric ropivacaine 0.75% for spinal anaesthesia in lower abdominal surgeries. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All ASA1 and 2 patients undergoing elective lower abdominal surgery under subarachnoid block. |
|
| ExclusionCriteria |
| Details |
All ASA 3 and 4
Patients with spinal deformity
Pregnant patients
Patients with height less than 140cm
Patients with known drug allergy, preexisting cardiovascular, respiratory and neurological disorders
Patients with local skin infections, impaired liver or renal function tests, coagulation disorders
Patients with BMI more than 30kg/m2
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to assess onset and duration of sensory blockade, maximum sensory blockade and the time taken for it, time taken for 2 segment regression, onset and duration of motor blockade, total duration of postoperative analgesia. |
1,2,3,4,5,10,15,20,25,30,35,40,45,50,55,60,65,70,75,80,85,90 minutes and till 3 hours postoperative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| changes in heart rate, SBP,DBP,MAP |
1, 1 1/2,2,21/2,3 hours |
|
|
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
20/03/2024 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a study to compare the effects of addition of Buprenorphine and Fentanyl as intrathecal adjuvants to 0.75% hyperbaric ropivacaine in prolonging duration of surgical anesthesia and prospective analgesia in patients undergoing lower abdominal surgeries and to determine which is the better adjuvant. |