| CTRI Number |
CTRI/2016/10/007397 [Registered on: 21/10/2016] Trial Registered Retrospectively |
| Last Modified On: |
30/12/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to note the effect of giving pregabalin before surgery on pain on patients going to have breast surgery |
|
Scientific Title of Study
|
Effect of perioperative administration of pregabalin on acute and chronic postoperative pain in patients undergoing breast 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 KCPant |
| Designation |
Professor |
| Affiliation |
SGPGIMS |
| Address |
Department of Anaesthesiology
SGPGIMS
Raebareilly road
lucknow-226014
uttar pradesh
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
8004904590 |
| Fax |
|
| Email |
kayceepant@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Zakia Saeed |
| Designation |
JR-2 |
| Affiliation |
SGPGIMS |
| Address |
Department of Anaesthesiology
SGPGIMS
Raebareilly road
lucknow-226014
uttar pradesh
B-14
insaaf nagar
near panigaon, munshipuliya
lucknow-226016
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
8004904607 |
| Fax |
|
| Email |
zakiasaeed2007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Zakia Saeed |
| Designation |
JR-2 |
| Affiliation |
SGPGIMS |
| Address |
Department of Anaesthesiology
SGPGIMS
Raebareilly road
lucknow-226014
uttar pradesh
B-14
insaaf nagar
near panigaon, munshipuliya
lucknow-226016
UTTAR PRADESH
226014
India |
| Phone |
8004904607 |
| Fax |
|
| Email |
zakiasaeed2007@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sanjay Gandhi Postgraduate Institute of Medical Sciences,Rae-Bareli road ,Lucknow ,Uttar Pradesh-226014 |
|
|
Primary Sponsor
|
| Name |
Sanjay Gandhi Postgraduate Institute of Medical Sciences |
| Address |
Sanjay Gandhi Postgraduate Institute of Medical Sciences,Raebareilly road ,Lucknow ,Uttar Pradesh-226014 |
| 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 KCPant |
Sanjay Gandhi Postgraduate Institute of Medical Sciences |
Preanaesthetic checkup clinic ,department of Anaesthesia,
Sanjay Gandhi Postgraduate Institute of Medical Sciences,Rae-Bareli road ,Lucknow ,Uttar Pradesh-226014
Lucknow
UTTAR PRADESH |
8004904590
kayceepant@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics commitee,SGPGIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
patients going to undergo mastectomy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
Patients in the control group will receive:
1st postoperative day: 1gm intravenous paracetamol 6 hourly.
2nd -5th postoperative day: 400 mg ibuprofen + 325 mg paracetamol orally 8 hourly
PLUS
Night before the surgery: Placebo capsule.
2 hours before the induction of anaesthesia: Placebo capsule.
1st- 5th postoperative day: Placebo capsule 12 hourly.
|
| Intervention |
Pregabalin |
Patients in the pregabalin group will receive:
1st postoperative day: 1gm intravenous paracetamol 6 hourly.
2nd -5th postoperative day: 400 mg ibuprofen + 325 mg paracetamol orally 8 hourly
PLUS
Night before the surgery: 75 mg Pregabalin capsule
(LYRICA ® , Pfizer Inc., Germany).
2 hours before the induction of anaesthesia: 75 mg Pregabalin capsule.
1st- 5th postoperative day: 75 mg Pregabalin capsule 12 hourly.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
ASA 1 and 2 patients going to undergo mastectomy with or without axillary clearance |
|
| ExclusionCriteria |
| Details |
1. Patient’s refusal.
2. If pregabalin is contraindicated.
3. If pregabalin or gabapentin has been previously used.
4. Preexisting pain at the site where the surgical incision will be made.
5. Presence of a coexisting chronic pain syndrome.
6. A deranged renal function test.
7. A recent history of alcohol or drug abuse.
8. Patients on treatment for seizures or having heart disease.
9. Diabetic patients on pioglitazone or rosiglitazone or hypertensive patients on ACE inhibitors .
10. Patients having history of any psychiatric illness.
11. The inability to understand numerical rating score(NRS) despite previous instruction.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
• To study the incidence of CPSP in both the groups .
• To study the quality of chronic pain relief in these patients at one month and three months postoperatively.
|
after 1 and 3 months of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• To compare the quality of acute pain relief in patients taking intravenous paracetamol and per oral combination of paracetamol and ibuprofen with patients taking pregabalin along with paracetamol and combination of paracetamol and ibuprofen after mastectomy with or without axillary clearance postoperatively.
• To study the incidence of side effects of pregabalin on the patients.
|
for 5 postoperative days after surgery |
|
|
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)
|
03/02/2015 |
| 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="1"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
to evaluate the effect of perioperative administration of pregabalin before and after surgery for 5 postoperative days on -
1. chronic pain after 1 and 3 months after surgery
2. acute pain after surgery for 5 days
3. incidence of side-effects of pregabalin in the patients
|