| CTRI Number |
CTRI/2024/05/067368 [Registered on: 15/05/2024] Trial Registered Prospectively |
| Last Modified On: |
13/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
The effect of giving tablet Tizanidine before surgery on pain level after surgery in patients undergoing breast surgery. |
|
Scientific Title of Study
|
The effect of oral Tizanidine as premedication on postoperative pain after breast surgery - a prospective randomised double blind 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 |
Dr R Anuradha |
| Designation |
Junior Resident |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
Department of Anaesthesia, Main OT Complex, 1st Floor, Ward Block, Indira Gandhi Institute of Medical Sciences, Sheikhpura, Patna, Bihar, India
Patna
BIHAR
800014
India |
| Phone |
9483307323 |
| Fax |
|
| Email |
anu931999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prakash Kumar Dubey |
| Designation |
Professor |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
Department of Anaesthesia, Main OT Complex, 1st Floor, Ward Block, Indira Gandhi Institute Of Medical Sciences, Sheikhpura, Patna, Bihar, India
Patna
BIHAR
800014
India |
| Phone |
9430511851 |
| Fax |
|
| Email |
pkdubey@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prakash Kumar Dubey |
| Designation |
Professor |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
Department of Anaesthesia, Main OT Complex, 1st Floor, Ward Block, Indira Gandhi Institute of Medical Sciences, Sheikhpura, Patna, Bihar, India
Patna
BIHAR
800014
India |
| Phone |
9430511851 |
| Fax |
|
| Email |
pkdubey@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Institute of Medical Sciences, Sheikhpura, Patna, Bihar, India, 800014 |
|
|
Primary Sponsor
|
| Name |
Dr R Anuradha |
| Address |
Department of Anaesthesia, Main OT Complex, 1st floor, Ward Block, Indira Gandhi Institute of Medical Sciences, Sheikhpura, Patna, Bihar, India, 800014 |
| 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 |
| Dr R Anuradha |
Indira Gandhi Institute of Medical Sciences |
Department of Anaesthesia and Critical Care Medicine, 1st Floor, Main OT Complex, Ward Block
Patna
BIHAR |
9483307323
anu931999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Indira Gandhi Institute Of Medical Sciences |
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 |
| Comparator Agent |
Placebo tablet |
Patients scheduled for breast surgery will be given oral placebo tablet 60 minutes prior to surgery which will be conducted under general anesthesia. |
| Intervention |
Tab. Tizanidine 4mg |
Patients scheduled for breast surgery will be given oral Tab. Tizanidine 4mg, 60 minutes prior to surgery which will be conducted under general anesthesia. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
Patients of ASA grade 1 and 2
Patients scheduled for carcinoma breast surgeries |
|
| ExclusionCriteria |
| Details |
History of moderate to severe congenital heart disease, neurological disorder, hepatic or renal diseases
Patients with hiatal hernia, major abdominal or thoracic surgery
Patients with history of alpha 2 agonist in last few days to months |
|
|
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 |
| Postoperative pain score and requirement of rescue analgesia. |
0 minute, 30 minutes, 60 minutes, 90 minutes, 2 hours, 3 hours, 4 hours,6 hours,12 hours, 24 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Length of PACU stay, patient satisfaction and any adverse events |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="86"
Sample Size from India="86"
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 4 |
|
Date of First Enrollment (India)
|
15/06/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Tizanidine is an alpha 2 agonist. It has analgesic and muscle relaxant properties. Post operative pain can cause adverse physiological effects including insufficient depth of breathing, failure to drain respiratory secretions and other pulmonary complications. This study will be done to evaluate the effect of Tizanidine on post operative pain after breast surgeries. It is a prospective double blind randomised control study. Post operative pain and requirement of rescue analgesic will be monitored. |