| CTRI Number |
CTRI/2017/01/007657 [Registered on: 10/01/2017] Trial Registered Retrospectively |
| Last Modified On: |
15/02/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Pain relief for knee replacement surgery |
|
Scientific Title of Study
|
Adductor canal block for post-operative analgesia after total knee replacement: a randomized controlled trial to study the effect of addition of dexmedetomidine to ropivacaine |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RAKHEE GOYAL |
| Designation |
Professor Anaesthesia |
| Affiliation |
Professor |
| Address |
Department of Anaesthesia
Army Hospital Research and Referral
Delhi
P 103/64
Married Accomodation
Army Hospital Research and Referral
Delhi
South West
DELHI
110010
India |
| Phone |
7798225637 |
| Fax |
01125684096 |
| Email |
rakheegoyalkumar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
RAKHEE GOYAL |
| Designation |
Professor Anaesthesia |
| Affiliation |
Professor Anaesthesia |
| Address |
Department of Anaesthesia
Army Hospital Research and Referral
Delhi
P 103/64
Married Accomodation
Army Hospital Research and Referral
Delhi
South West
DELHI
110010
India |
| Phone |
7798225637 |
| Fax |
01125684096 |
| Email |
rakheegoyalkumar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
RAKHEE GOYAL |
| Designation |
Professor Anaesthesia |
| Affiliation |
Professor Anaesthesia |
| Address |
Department of Anaesthesia
Army Hospital Research and Referral
Delhi
P 103/64
Married Accomodation
Army Hospital Research and Referral
Delhi
South West
DELHI
110010
India |
| Phone |
7798225637 |
| Fax |
01125684096 |
| Email |
rakheegoyalkumar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Army Hospital Research and Referral
Delhi |
|
|
Primary Sponsor
|
| Name |
Army Hospital Research and Referral Delhi |
| Address |
Department of Anaesthesia
Army Hospital Research and Referral
Delhi |
| 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 Rakhee Goyal |
Army Hospital Research and Referral Delhi |
Department of Anaesthesia
Level III
Army Hospital Research and Referral
Delhi
South West
DELHI |
7798225637
01125684096
rakheegoyalkumar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Those scheduled for knee replacement surgery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Adductor canal block with ropivacaine and 0.50 μg/kg of dexmedetomidine |
The block will be given with ropivacaine (0.3%) along with 0.50 μg/kg of dexmedetomidine in a total volume of 20 mlas a single injection in the adductor canal under ultrasound guidance. The results will be assessed over 24 hours. |
| Intervention |
Adductor Canal Block, Ropivacaine, Dexmedetomidine |
The block will be given with ropivacaine alone (0.3%) without any additives in a total volume of 20 ml as a single injection in the adductor canal under ultrasound guidance. The results will be assessed over 24 hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
ASA I-III; BMI 20-30 kg/m2 |
|
| ExclusionCriteria |
| Details |
Contraindication to subarachnoid block or allergy to any of the study drugs;
Known coagulopathy, local infection at block site;
Patients in whom the nerve block could not be performed at per the procedure described in the methodology; Renal dysfunction
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The aim of this study is to compare the duration of analgesia of adductor canal block using ropivacaine with and without dexmedetomidine after total knee replacement. |
15 min, 30 min, 45 min, 60 min, 6 hr, 12 hr, 18 hr, 24 hr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcomes will be the total 24 hr opioid consumption, success of early ambulation, level of patient satisfaction, and any adverse effects following the study intervention. |
Medical Research Council Scale as 0-5 at 6, 12, 18 and 24 hr after the block. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2016 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NOT YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Total knee replacement is almost always
associated with severe post-operative pain. The current aim of adequate
analgesia and early ambulation is directed at decreased hospital stay and
increased patient satisfaction. Multimodal analgesia such as central and
peripheral nerve blocks, NSAIDS, paracetamol, opioids, etc. is most suitable
for this surgery. However, in elderly patients there are concerns about the use
of opioids and NSAIDs. The recent success of adductor canal block in providing
post-operative analgesia, along with the prospects of early ambulation has
evoked interest in studying the effects of local anesthetics like ropivacaine,
and some adjuvants like dexmedetomidine. Both ropivacaine and dexmedetomidine
have been effectively and safely used in the past in other peripheral nerve
blocks.The aim of this study is to compare the duration
of analgesia of adductor canal block using ropivacaine with and without dexmedetomidine
after total knee replacement.The secondary outcomes will be the total 24
hr opioid consumption, success of early ambulation, level of patient satisfaction,
and any adverse effects following the study intervention.
|