A Prospective Study of the Effects of Pregabalin versus Placebo on the incidence and intensity of pain after video-assisted thoracoscopic surgery.

A Prospective Study of the Effects of Pregabalin versus Placebo on the incidence and intensity of pain after thoracoscopic surgery

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000554662

Enrollment

Registered

2014-05-23

Start date

2007-10-10

Completion date

2013-04-23

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

The study proposes to investigate whether a drug with specific effects which damp excessive nerve mediated activity can prevent the long term occurence of pain after chest surgery.

Interventions

prevention of long term pain following thorocotomy operation. Intervention involves using 300mg oral pregabalin administered prior to commencement of thoracoscopic surgery (day 1) and continued for a further 5 postoperative days (day 6). Both preoperative pregabalin and postoperative pregabalin are compared with oral placebo. Blinded nursing staff in hospital administering pregabalin/placebo will sign medication chart to confirm that the pregabalin/placebo has been taken by the participant.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

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

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

Patients having video assisted thoracoscopic surgery (VATS) Conscious Able to understand use of "PCA" ( Patient Controlled Analgesia)

Exclusion criteria

Morphine or paracetamol contraindication or allergy Allergy to pregabalin History of chronic pain Evolving myocardial infarction, arrhythmias at time of surgery Preoperative respiratory function tests showing a forced vital capacity<60% predicted, forced expiratory volume 1s <60%, or both Renal insufficiency (creatinine >15mg/dL) Liver dysfunction (aspartate aminotransferase, alanine aminotransferase, or both >40u/L)

Outcome results