| CTRI Number |
CTRI/2015/08/006124 [Registered on: 20/08/2015] Trial Registered Retrospectively |
| Last Modified On: |
03/08/2015 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
comparison between dexamethasone and dexmedetomidine as an adjunct to ropivacaine in post operative shoulder surgery |
|
Scientific Title of Study
|
A randomised double blind study comparing dexmedetomidine with dexamethasone as an adjunct to ropivacaine in ultrasound guided interscalene block for shoulder surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sukanya Mitra |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital, Sector 32, Chandigarh. |
| Address |
Department of Anaesthesia and Intensive Care, Government Medical College and Hospital, Chandigarh.
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121521 |
| Fax |
|
| Email |
drsmitra12@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sukanya Mitra |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital, Sector 32, Chandigarh. |
| Address |
Department of Anaesthesia and Intensive Care, Government Medical College and Hospital, Chandigarh.
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121521 |
| Fax |
|
| Email |
drsmitra12@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sukanya Mitra |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital, Sector 32, Chandigarh. |
| Address |
Department of Anaesthesia and Intensive Care, Government Medical College and Hospital, Chandigarh.
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121521 |
| Fax |
|
| Email |
drsmitra12@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College and Hospital, sector 32, chandigarh. |
|
|
Primary Sponsor
|
| Name |
Government Medical College and Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Government Medical and Hospital, Chandigarh. |
| Type of Sponsor |
Government medical college |
|
|
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 Sukanya Mitra |
Government Medical College and Hospital, sector 32, chandigarh |
department of Anaesthesia and Intensive Care,fifth floor, D Block,Government medical college and hospital , sector 32 , chandigarh
Chandigarh
CHANDIGARH |
9646121521
drsmitra12@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics commitee ( GMCH Chandigarh ) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
healthy patients with ASA grade 1-2, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
group 1 |
ultrasound guided interscalene block with .5 % ropivacaine 20 ml containing dexamethasone ( 8 mg ) to a total of 22 ml |
| Comparator Agent |
group 2 |
ultrasound guided interscalene block with .5 % ropivacaine 20 ml with 2 ml of saline containing dexmedetomidine .5 mcg/kg to a total of 22 ml. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA status 1-2
2. BMI - 18-30 kg/m2
3. Shoulder surgery such as rotator cuff repair, recurrent shoulder dislocations, acromioplasty, hemiarthroplasty and total shoulder replacement. |
|
| ExclusionCriteria |
| Details |
1. patient refusing to give informed consent
2. history of relevant drug allergy
3. history of psychiatric illness, substance abuse
4. severe cardiovascular, respiratory, metabolic or neurologic disease
5. pregnancy and lactation
6. coagulopathy
7. contralateral phrenic nerve dysfunction
8. infection at planned injection site
9.patients receiving alpha 2 agonists for hypertensive disorders
10.patients on steroids |
|
|
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 |
| duration of post-operative analgesia as measured ( in minutes ) by the time from the achievement of adequate sensory block till the first use of fentanyl bolus by PCA |
o hour- time at which adequate sensory block is achieved
To time till the patient takes first dose of rescue analgesic( in 24 hours ) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| pain ratings over 24 hours on 0-100 VAS , total post-operative analgesic consumption, patient satisfaction and adverse effects. |
2 hourly monitoring after 4 hours of nerve block upto 24 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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/04/2015 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomised ,double blind, single centre trial comparing the efficacy of dexamethasone and dexmedetomidine for post operative analgesia and cumulative total analgesic consumption when administered under ultrasound guidance as an adjunct to ropivacaine in interscalene block.it will be done in a period of 2 years in ASA 1 patients. pain will be assessed on basis of VAS score. Two groups will be studied , group 1 using .5 % ropivacaine 20 ml containing dexamethasone ( 8 mg ) to a total of 22 ml. group 2 using .5 % ropivacaine 20 ml with 2 ml of saline containg dexmedetomidine .5 mcg/kg to a total of 22 ml. Primary outcome will see the duration of postoperative analgsia, in minutes by the time from the achievement of adequate sensory block till the first use of fentanyl bolus by PCA. Secondary outcome will measure pain ratings over 24 hour on 0-100 VAS ,total postoperative analgesic consumption ,patient satisfaction and adverse effects. |