Ibuprofen or Morphine in Treating Pain in Patients Undergoing Pleurodesis for Malignant Pleural Effusion

NHS Trust

Status and phase: Unknown; Phase 2

Conditions: Metastatic Cancer

Treatments: Drug: ibuprofen; Drug: morphine sulfate; Procedure: pleurodesis; Procedure: management of therapy complications

Study type: Interventional

Funder types: Other

Identifiers

NCT00644319

UKCRN 4035

ISRCTN33288337

CDR0000590072

EU-20829

RADCLIFFE-TIME1

EUDRACT 2006-005226-31

Details and patient eligibility

About

RATIONALE: Morphine and ibuprofen help lessen pain caused by pleurodesis. It is not yet known whether one drug is more effective than the other in lessening pleurodesis-related pain or whether the size of the chest drain tube affects pain.

PURPOSE: This randomized clinical trial is studying ibuprofen to see how well it works compared with morphine in treating pain in patients undergoing pleurodesis for malignant pleural effusion.

Full description

OBJECTIVES:

Primary

• To evaluate the efficacy of a non-steroidal based regimen comprising ibuprofen in decreasing post-pleurodesis pain as compared to an opiate-based regimen comprising morphine sulfate in patients with malignant pleural effusion.
• To evaluate whether chest drain size influences the amount of post-pleurodesis pain.

OUTLINE: This is a multicenter study. Patients are stratified according to histological tissue type (mesothelioma vs non-mesothelioma) and thoracoscopic procedure. Patients are randomized to 1 of 4 treatment arms.

• Arm I: Patients undergo pleurodesis after placement of a large bore chest drain (24F) on day 0 and receive oral ibuprofen 3 times daily for 3 days. The chest tube is removed on day 3.
• Arm II: Patients undergo pleurodesis after placement of a small bore chest drain (12F) on day 0 and receive oral ibuprofen 3 times daily for 3 days. The chest tube is removed on day 3.
• Arm III: Patients undergo pleurodesis after placement of a large bore chest drain (24F) on day 0 and receive oral morphine sulfate 4 times daily for 3 days. The chest tube is removed on day 3.
• Arm IV: Patients undergo pleurodesis after placement of a small bore chest drain (12F) on day 0 and receive oral morphine sulfate 4 times daily for 3 days. The chest tube is removed on day 3.

All patients will receive regular background analgesia comprising paracetamol 4 times daily on days 0-3. Patients not adequately treated with these regimens may also receive rescue analgesia comprising morphine sulfate IV on days 0-3.

After completion of study treatment, patients are followed at 1, 3, and 6 months, and periodically thereafter.

Enrollment: 320 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Diagnosis of malignant pleural effusion requiring pleurodesis confirmed by 1 of the following:

  • Histologically proven pleural malignancy
  • Typical features of pleural malignancy seen on direct vision during thoracoscopy
  • Pleural effusion in the context of histologically proven cancer elsewhere

• No primary lymphoma or small cell lung carcinoma

• All patients undergoing thoracoscopy for suspected malignant pleural effusion are eligible

PATIENT CHARACTERISTICS:

• Life expectancy > 1 month
• Not pregnant or nursing
• No history of GI bleeding or untreated peptic ulceration
• No known sensitivity to non-steroidal anti-inflammatory drugs (NSAIDs), opiates, or paracetamol
• No hypercapnic respiratory failure
• No known intravenous drug abuse
• No severe renal or liver disease
• No known bleeding diathesis
• Able to give informed consent

PRIOR CONCURRENT THERAPY:

• More than 2 weeks since prior and no concurrent corticosteroid therapy

• No concurrent warfarin therapy

• No other concurrent analgesics

  • Analgesics used as a breakthrough regimen are allowed from trial entry to tube withdrawal at day 3 post-pleurodesis (i.e., regular paracetamol, assigned study analgesia, and breakthrough medication only, including opiate slow release patches)

• No concurrent enrollment on another clinical study

  • Patients may participate in other trials immediately after completion of current trial, excluding those involving further pleural procedures or analgesia trials in which patients must wait at least 3 months after completion of current trial