The Effects of Pregabalin on Postoperative Pain After Cardiac Surgery

Phase 2

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: Pregabalin 75mg; Drug: pregabalin 150 mg; Drug: Placebo

• Registration Number: NCT01701921
• Lead Sponsor: Larissa University Hospital

Brief Summary

The purpose of this study is to determine whether pregabalin is effective in the treatment of acute postoperative pain after cardiac surgery if administered before the surgery.

Detailed Description

Pregabalin was introduced as an antiepileptic drug with analgesic anti-hyperalgesic and anxiolytic properties and was also used to treat neuropathic pain. In recent years it has been used as part of a multimodal management of acute postoperative pain after various types of surgery. We study the effect of pregabalin administered before cardiac surgery on acute and chronic postoperative pain. Post CABG syndrome is well known since 1980 and various analgesic methods have been used from time to time (opioids, regional analgesia, non-steroidal anti-inflammatory drugs). In our research patients will be divided into three groups. The control group will receive a placebo capsule before surgery. The second group will receive 75mg of pregabalin per os before surgery while the third will receive 150mg of pregabalin. After the surgery all patients will be connected to an intravenous PCA morphine pump for 48 hours. The postoperative pain will be assessed with the Visual Analogue Scale (0-10) every day. Total morphine consumption by the patients as well as any other pain medications administered supplementary will be registered and compared between the different groups. Remaining postoperative pain will be assessed after 3 months. The results will be statistically analyzed in order to determine whether there is significant difference in pain management between the groups.

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2012-10-03
• Study First Submitted QC: 2012-10-03
• Study First Posted: 2012-10-05
• Primary Completion: 2016-02
• Study Completion: 2016-06
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-08
• Last Update Posted: 2016-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

• Patients' age 18-85years who are undergoing cardiac surgery

Exclusion Criteria

• Chronic pain syndromes
• Renal failure
• Age >85
• Allergy to Pregabalin
• Patients already taking pregabalin

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pregabalin 75	Pregabalin 75mg	Pregabalin 75mg by mouth one hour before surgery
Pregabalin 150	pregabalin 150 mg	Pregabalin 150mg by mouth one hour before surgery
Sugar pill	Placebo	Placebo : Sugar pill manufactured to mimic pregabalin capsule by mouth one hour before surgery

Primary Outcome Measures

Name	Time	Method
opioid consumption and other analgesics after surgery	24 hours after surgery	Patients will be questioned about postoperative pain and opioid consumption will be measured during the first 24 hours after surgery. Other analgesics they may receive will also be recorded.

Secondary Outcome Measures

Name	Time	Method
Remaining surgery related pain and analgesics consumption	3 months after surgery	Patients will be questioned three month after surgery about the presence of post operative pain, whether it affects their quality of life and whether they are receiving pain treatment

Trial Locations

Locations (1)

Univercity Hospital of Larissa; 🇬🇷 Larissa, Thessaly, Greece