Can a painkiller for nerve damage (pregabalin) prevent chronic pain after open heart surgery?

Pregabalin for the prevention of chronic pain after cardiac surgery: a randomised, double-blind, placebo-controlled trial

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12619000428167

Acronym

PRACS

Enrollment

200

Registered

2019-03-15

Start date

2019-04-01

Completion date

2020-04-01

Last updated

2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Chronic pain (3 months) occurs in up to two-thirds of patients after open-cardiac surgery. This is predominantly neuropathic pain; a consequence of nerve damage during instrumentation. Previous studies have shown pregabalin effectively reduces acute pain after cardiac surgery. There is, however, a lack of research regarding chronic pain. The PRACS (pregabalin for the prevention of chronic pain after open-cardiac surgery) trial aims to reduce chronic pain and improve quality of life for cardiac patients. This randomised, double-blind, placebo-controlled trial is a collaboration between anaesthetics, ICU and cardiothoracic surgery at Monash Medical Centre. We aim commence the trial in early 2019 with a target sample of 200 patients. The intervention group will receive active pregabalin (150mg before surgery and 75mg 12-hourly for 48 hours after surgery) while the control group will receive matching placebo. Participants will be monitored in hospital and at the 3 and 6 month mark

Interventions

Pregabalin (oral) 150mg capsule 2 hours before surgery 75mg capsule 12-hourly for 48 hours after surgery Medication to be administered under direct observation by treating nurse

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

16 Years to No maximum

Healthy volunteers

Inclusion criteria

All adult patients undergoing open-cardiac surgery via sternotomy (e.g. coronary artery bypass grafting, valve replacement)

Exclusion criteria

Salvage surgery; Endovascular surgery; Patients receiving renal dialysis; Patients taking antiepileptic agents; Patients taking chronic opioids or non-steroidal anti-inflammatory drugs (NSAIDs); Patients taking psychotropic medications for a known chronic psychiatric condition; Patients with Parkinson’s disease; and Patients with dementia (diagnosed reduction in cognitive function).

Outcome results