| CTRI Number |
CTRI/2013/11/004168 [Registered on: 22/11/2013] Trial Registered Retrospectively |
| Last Modified On: |
17/11/2019 |
| 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
|
Comparison of analgesic action of two doses of dexmedetomidine, when used in addition to bupivacaine, in femoral nerve block given to reduce post operative pain after total knee replacement surgery |
|
Scientific Title of Study
|
EFFECT OF DEXMEDETOMIDINE AS AN ADJUVANT TO BUPIVACAINE IN FEMORAL NERVE BLOCK FOR PERIOPERATIVE ANALGESIA IN PATIENTS UNDERGOING TOTAL KNEE REPLACEMENT ARTHROPLASTY UNDER SUBARACHNOID BLOCK - A DOSE RESPONSE STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Senthil Packiasabapathy |
| Designation |
junior resident (academic) |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Anaesthesiology,
5th floor, Teaching block,
All India Institute of Medical sciences, Ansari Nagar, New Delhi
South West
DELHI
110029
India |
| Phone |
9968889932 |
| Fax |
|
| Email |
ksenps@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Lokesh Kashyap |
| Designation |
professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room no.5018, 5th floor, Teaching block,
All Inddia Institute of Medical sciences, Ansari Nagar, New Delhi
South West
DELHI
110029
India |
| Phone |
9868397821 |
| Fax |
|
| Email |
lokeshkashyap@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Lokesh Kashyap |
| Designation |
professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room no.5018, 5th floor, Teaching block,
All Inddia Institute of Medical sciences, Ansari Nagar, New Delhi
South West
DELHI
110029
India |
| Phone |
9868397821 |
| Fax |
|
| Email |
lokeshkashyap@yahoo.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| All India Institute of Medical Sciences |
All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Senthil Packia Sabapathy |
All India Institute of Medical Sciences |
Department of aneaesthesia, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029
South West
DELHI |
9968889932
ksenps@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee, ethics subcommittee, AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
American Society of Anesthesiologists Physical status classes 1, 2, (1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
dexmedetomidine |
Dexmedetomidine is used as an adjuvant to prolong the analgesic action of local anesthetic agent. In one group dose given is 1 microgram per kilogram bodyweight. In second group dose is 2 microgram per kilogram. It is given along with 20 mL of 0.25% bupivacaine in both the groups as a single injection femoral nerve block prior to the surgery. |
| Intervention |
femoral nerve block |
nerve stimulator guided femoral nerve block is used for post operative analgesia in total knee replacement |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1, 2 patients undergoing unilateral primary total knee replacement arthroplasty |
|
| ExclusionCriteria |
| Details |
ASA 3,4, bilateral, revision TKR,focal neurological deficits, pre existing peripheral neuropathy,uncontrolled diabetes mellitus,coagulation disorders |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Quality of post operative analgesia as assessed by,
1) VAS (0-10 scale; 0-no pain; 10-worst possible pain)
• pain at rest at 0, 4, 8, 12, 24, 48 hours after surgery
• pain at motion (knee flexion) at 12, 24, 48 hours after surgery
2) Post operative opioid consumption: Total dose of PCA morphine consumed, dose of rescue analgesia used.
3) Duration of analgesia: Time to first use of patient controlled analgesia
|
Quality of post operative analgesia as assessed by,
1) VAS (0-10 scale; 0-no pain; 10-worst possible pain)
• pain at rest at 0, 4, 8, 12, 24, 48 hours after surgery
• pain at motion (knee flexion) at 12, 24, 48 hours after surgery
2) Post operative opioid consumption: Total dose of PCA morphine consumed, dose of rescue analgesia used.
3) Duration of analgesia: Time to first use of patient controlled analgesia
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adverse effects of dexmedetomidine in peripheral nerve block such as nausea, vomiting, pruritus, sedation, hypotension, bradycardia, neuropathy in the perioperative period will be recorded |
Adverse effects of dexmedetomidine in peripheral nerve block such as nausea, vomiting, pruritus, sedation, hypotension, bradycardia, neuropathy in the perioperative period will be recorded |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2013 |
| Date of Study Completion (India) |
31/12/2014 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/12/2014 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Total knee replacement is a very painful procedure, post operative pain impairs early patient mobilization which is the key to the success of the procedure. Dexmedetomidine when used as an adjuvant to local anesthetic agent in peripheral nerve blocks is found to increase duration of the block, in various studies. This adjuvant property of dexmedetomidine is studied in this thesis to provide good quality post operative analgesia in patients undergoing TKR. This study is a dose comparison study which includes three groups, one control group receiving plain bupivacaine in femoral nerve block, second group receiving 1microgram/kilogram of dexmedetomidine along with bupivacaine in the block. The third group receiving 2microgram/kilogram of dexmedetomidine along with bupivacaine in the block. The post operative pain scores, opioid consumption as well as adverse effects are compared. The data will be statistically analyzed.This is a randomized, controlled, double blinded study. The sample size is sixty. |