| CTRI Number |
CTRI/2017/09/009830 [Registered on: 18/09/2017] Trial Registered Retrospectively |
| Last Modified On: |
19/09/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare two doses of a drug used for pain control given in a pain control technique for patients undergoing breast cancer surgery |
|
Scientific Title of Study
|
A Prospective randomised double blinded trial comparing two doses of dexmedetomidine added to ropivacaine for paravertebral block during modified radical mastectomy for postoperative analgesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sangeeta Chakraborty |
| Designation |
Junior Resident |
| Affiliation |
King George Medical University |
| Address |
Department of Anaesthesiology and Critical Care, King Georges Medical University, lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9830356827 |
| Fax |
|
| Email |
brightsky@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Raman |
| Designation |
Assistant Professor |
| Affiliation |
King George Medical University |
| Address |
Dept of Anaesthesiology, King George Medical University
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9451564339 |
| Fax |
|
| Email |
ramanrajesh83@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajesh Raman |
| Designation |
Assistant Professor |
| Affiliation |
King George Medical University |
| Address |
Dept of Anaesthesiology, King George Medical University
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9451564339 |
| Fax |
|
| Email |
ramanrajesh83@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Sangeeta Chakraborty, Dept of Anaesthesiology, King Georges Medical University, Lucknow, UP |
|
|
Primary Sponsor
|
| Name |
Sangeeta Chakraborty |
| Address |
Gautam Buddha Hostel , King George Medical University,lucknow |
| 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 Sangeeta Chakraborty |
King Georges Medical University |
Department Of Anaesthesiology, KGMU
Lucknow
UTTAR PRADESH |
9830356827
brightsky@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| King George Medical University institutinal ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Breast Cancer , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
paravertebral block with ropivacaine |
18 ml 0.75% ropivacaine in single site unilateral paravertebral block |
| Intervention |
paravertebral block with ropivacaine and dexmeddetomidine |
0.75% ropivacaine 18 ml with 0.5 mcg/kg dexmedetomidine in unilateral single site paravertebral block |
| Intervention |
Paravertebral block with ropivacaine with dexmedetomidine |
0.75% ropivacaine 18ml with 1 mcg/kg dexmedetomidine single site unilateral presurgical paravertebral block |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
ASA I & II |
|
| ExclusionCriteria |
| Details |
1. Patients who refrained from giving an informed consent
2. Those with spinal or chest wall deformity and/or local infection at site of block.
3. Patients with coagulopathy
4. Patients with hypersensitivity to either ropivacaine or dexmedetomidine
5. Patient who had cognitive abnormalities due to underlying psychiatric comorbidities or patients who were not cooperative.
6. Heart block, moderate or severe stenotic/regurgitant heart lesions.
7. Patient with BMI<18.5 or>30, height <150 cm and > 195 cm .
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post operative analgesia intensity and duration |
Just after the end of the surgery and then 4 hourly till 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Heart rate, Mean Arterial Pressure, Spo2, side effects, complications, patient satisfaction |
Intraoperatively and just after the end of the surgery and then 4 hourly upto 24 hours |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
Phase of Trial
Modification(s)
|
N/A |
|
Date of First Enrollment (India)
|
01/06/2016 |
| Date of Study Completion (India) |
31/05/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not published yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A comparative study where 60 patients were allocated in three groups. group A received 18 ml 0.75% ropivacaine with 1 mcg/kg dexmedetomidine, group B 18 ml ropivacaine 0.75% with 0.5 mcg/kg dexmedetomidine , group C (control) 18 ml 0.75% ropivacaine only in single site paravertebral block preoperatively in patients undergoing modifoed radical mastectomy for Ca breast. Then stansdard GA was given for proceeding with the surgery. Intraoperative and postoperative ,mean arterial pressure, heart rate, spo2 , side effects, complications and postoperative pain score and duration of analgesia in terms of time and amount of first rescue analgesic dose was compared among three groups. Three groups were comparable in terms of demography and baseline data. Intraoperatively the group receiving 1mcg/kg dexmedetomidine(group A) showed lower MAP and heart rate as compared to two other groups in most of the period , Whereas heart rate and SPO2 was mostly stable in other two groups(group B and C). Post operative pain score(VAS) along with duration of analgesia was better in both the groups receiving dexmedetomidine (group A and group B) as compared to the control group(group C) whereas these results were comparable between group A and B. |