The Effects of Pregabalin on Postoperative Pain After Cardiac Surgery

Postoperative Pain Clinical Trial

Official title:

The Effects of Pregabalin on Acute and Chronic Postoperative Pain After Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01701921
• Other study ID #: 7/13-07-2011
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 3, 2012
• Last updated: September 8, 2016
• Start date: July 2011
• Est. completion date: June 2016

Study information

• Verified date: September 2016
• Source: Larissa University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: June 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Pregabalin 75mg
Pregabalin 75mg by mouth one hour before surgery
• pregabalin 150 mg
pregabalin 150mg by mouth one hour before surgery
• Placebo
Sugar pill designed to mimic pregabalin capsule, by mouth one hour before surgery

Locations

Country	Name	City	State
Greece	Univercity Hospital of Larissa	Larissa	Thessaly

Sponsors (1)

Lead Sponsor	Collaborator
Larissa University Hospital

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	opioid consumption and other analgesics 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.	24 hours after surgery	No
Secondary	Remaining surgery related pain and analgesics consumption	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	3 months after surgery	No