A prospective blinded randomised placebo controlled trial investigating whether oxycodone modified release reduces parenteral opioid use following intermediate thoracic surgery - OxyPATS

Phase 1

• Conditions: The management of acute pain after intermediate thoracic surgery; MedDRA version: 9.1 Level: LLT Classification code 10066714 Term: Acute pain

• Registration Number: EUCTR2007-007877-22-GB
• Lead Sponsor: Royal Brompton & Harefield NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-02-08
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 44

Inclusion Criteria

oAdults over the age of 18 years able to give informed consent
oPatients able to write and understand English
oPatients scheduled for intermediate thoracic surgery, likely to require intravenous patient controlled analgesia (PCA). This group may include patients scheduled for talc pleurodesis or pleural abrasion.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

oPatients having heart, heart-lung and lung transplantation surgery
oPatients who have had a previous thoracotomy
oPatients scheduled for thoracotomy
oPatients with pre-operative opioid use (thus not opioid naive)
oPatients with chronic painful syndromes
oInability to understand the concept of PCA
oInability to understand English
oKnown allergy or sensitivity to opioids
o Previous Abdominal Surgery (including oesophageal/gastric)
oPatients taking medicines to enhance gastric transit (eg metoclopramide)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified