| CTRI Number |
CTRI/2018/08/015353 [Registered on: 16/08/2018] Trial Registered Prospectively |
| Last Modified On: |
13/08/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparing pain relieving efficacy of oral clonidine and oral pregabalin given pre-emptively to patients planned for upper limb surgeries under regional anesthesia |
|
Scientific Title of Study
|
Comparative analgesic efficacy of pre-emptive oral clonidine and oral pregabalin in patients undergoing upper limb surgeries under supraclavicular block.A randomised,controlled prospective study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sheena Sharma |
| Designation |
Post Graduate student |
| Affiliation |
Dr. R.P.G.M.C Kangra at Tanda. |
| Address |
Department of Anesthesiology,Dr. R.P.G.M.C Kangra at Tanda.
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
7837985732 |
| Fax |
|
| Email |
sharmasheena043@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jai Singh |
| Designation |
Professor |
| Affiliation |
Dr. R.P.G.M.C Kangra at Tanda. |
| Address |
Department of Anesthesiology,Dr. R.P.G.M.C Kangra at Tanda.
Department of Anesthesiology, Dr. R.P.G.M.C Kangra at Tanda. 176001
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418070893 |
| Fax |
|
| Email |
drjaisingh62@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sheena Sharma |
| Designation |
Post Graduate student |
| Affiliation |
Dr. R.P.G.M.C Kangra at Tanda. |
| Address |
Department of Anesthesiology,Dr. R.P.G.M.C Kangra at Tanda.
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
7837985732 |
| Fax |
|
| Email |
sharmasheena043@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology, Dr. R.P.G.M.C Kangra at Tanda - 176001 H.P. |
|
|
Primary Sponsor
|
| Name |
Dr RPGMC Kangra at Tanda |
| Address |
Department of Anesthesiology Dr RPGMC Kangra at Tanda-176001 H.P. |
| 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 |
| Sheena Sharma |
Dr. Rajendra Prasad Government Medical College |
2nd Floor, OT Complex, Dr. Rajendra Prasad Government Medical College, Kangra at Tanda, HIMACHAL PRADESH.
Kangra
HIMACHAL PRADESH |
7837985732
sharmasheena043@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. RPGMC Kangra at Tanda Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients posted for upper limb surgeries under supraclavicular block having ASA Grade I-II., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Clonidine |
Clonidine 200mcg tablets orally, once, one hour before surgery. |
| Comparator Agent |
Control |
Colour matched B complex tablets orally, once, one hour before the surgery. |
| Comparator Agent |
Pregabalin |
Oral pregabalin 150mg tablets orally, once, one hour before the surgery. |
| Intervention |
Supraclavicular block |
USG supraclavicular block will be given using 20ml of 2% lignocaine with adrenaline (1 in 2 lakhs) will be injected and sensory and motor effects will be noted. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Scheduled for upper limb surgeries under supraclavicular block.
2. ASA Grade I-II.
3. BMI 18.5-29.9. |
|
| ExclusionCriteria |
| Details |
1. Patient’s refusal for block
2. Patients with known drug allergy to study
3. Patients who have taken analgesics 48hrs before
4. Use of antiepileptics drugs
5. Hepatic and renal pathologies affecting drug clearence
6. History of long term usage of NSAIDs and opioid analgesics
7. Patient in whom the block effect will be partial and will require supplementary analgesic
8. Diabetes mellitus and other neuropathic disorders
9. Any contraindications for peripheral nerve blocks
10. Coagulopathy disorders
11. Psychiatric disorders
12. Addiction to any drug |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study and compare block characteristics and rescue analgesic requirement with pre-emptive oral clonidine and oral pregabalin. |
24hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study and compare post-operative sedation and patient satisfaction. |
24hours |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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
|
N/A |
|
Date of First Enrollment (India)
|
26/08/2018 |
| 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
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Study Title: Comparative analgesic efficacy of pre-emptive oral clonidine and oral pregabalin in patients undergoing upper limb surgeries under supraclavicular block: A randomized, controlled, prospective study. Patients fulfilling the inclusion/exclusion criteria would be divided into three groups by block randomization and would receive clonidine 200mcg tablets, pregabalin 150mg tablets and placebo [colour matched B complex tablets] respectively. Patients will be assessed for a time duration of 24 hours for effect of pre-emptive oral clonidine and oral pregabalin on block characteristics (sensory motor onset and duration), post-operative rescue analgesic requirement, post-operative sedation and patient’s satisfaction. |