A study to note the effect of giving pregabalin before surgery on pain on patients going to have breast surgery

Completed

• Conditions: patients going to undergo mastectomy

• Registration Number: CTRI/2016/10/007397
• Lead Sponsor: Sanjay Gandhi Postgraduate Institute of Medical Sciences

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-02
• Last Update Posted: 2016-12-30

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

ASA 1 and 2 patients going to undergo mastectomy with or without axillary clearance.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
•To study the incidence of CPSP in both the groups .	after 1 and 3 months of surgery
•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 Measures

Name	Time	Method
•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.

Trial Locations

Locations (1)

Sanjay Gandhi Postgraduate Institute of Medical Sciences; 🇮🇳 Lucknow, UTTAR PRADESH, India

Sanjay Gandhi Postgraduate Institute of Medical Sciences

🇮🇳Lucknow, UTTAR PRADESH, India

Dr KCPant

Principal investigator

8004904590

kayceepant@yahoo.com