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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-007877-22-GB

Enrollment

Registered

2008-02-08

Start date

2008-07-10

Completion date

Unknown

Last updated

2019-12-10

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

Conditions

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

Interventions

Trade Name: OxyContin prolonged release tablets 10mg Pharmaceutical Form: Prolonged-release tablet INN or Proposed INN: oxycodone hydrochloride Current

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: o Adults over the age of 18 years able to give informed consent o Patients able to write and understand English o Patients 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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine if oxycodone modified release reduces static and dynamic pain intensity after intermediate thoracic surgery. ; Secondary Objective: Does OxyContin (modified release Oxycodone) 10mg bd reduce intravenous morphine Patient Controlled Analgesia (PCA) consumption in the immediate 48hrs postoperatively? Does OxyContin 10mg bd reduce the frequency and intensity of opioid related side-effects? Does OxyContin10mg improve the quality of patients’ recovery and reduce hospital length of stay? ; Primary end point(s): Parenteral opioid (PCA morphine) consumption in mg at 12, 24, 36 and 48 hours Static pain intensity measured using a visual analogue scale (SVAS) at 4 hour intervals Dynamic pain intensity measured using a visual analogue scale (DVAS) at 4 hours intervals Pain location, nature and PPI measured using the short form McGill Pain Questionnaire (SF-MPQ) Quality of recovery measured using the QOR-40 assessment tool Duration of hospital stay	—

Measure

Time frame

Main Objective: To determine if oxycodone modified release reduces static and dynamic pain intensity after intermediate thoracic surgery. ; Secondary Objective: Does OxyContin (modified release Oxycodone) 10mg bd reduce intravenous morphine Patient Controlled Analgesia (PCA) consumption in the immediate 48hrs postoperatively? Does OxyContin 10mg bd reduce the frequency and intensity of opioid related side-effects? Does OxyContin10mg improve the quality of patients’ recovery and reduce hospital length of stay? ; Primary end point(s): Parenteral opioid (PCA morphine) consumption in mg at 12, 24, 36 and 48 hours Static pain intensity measured using a visual analogue scale (SVAS) at 4 hour intervals Dynamic pain intensity measured using a visual analogue scale (DVAS) at 4 hours intervals Pain location, nature and PPI measured using the short form McGill Pain Questionnaire (SF-MPQ) Quality of recovery measured using the QOR-40 assessment tool Duration of hospital stay

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026