TIME1: A 2 X 2 Factorial Trial to Assess Whether Non-Steroidal Anti-Inflammatory Analgesics and Small-Bore Chest Tubes Are Less Painful Than Opiate Analgesics and Large-Bore Chest Tubes in Pleurodesis for Malignant Pleural Effusion.
18 Years
N/A
Both
Malignant Pleural Effusion, Pleural Effusion
Trial Information
TIME1: A 2 X 2 Factorial Trial to Assess Whether Non-Steroidal Anti-Inflammatory Analgesics and Small-Bore Chest Tubes Are Less Painful Than Opiate Analgesics and Large-Bore Chest Tubes in Pleurodesis for Malignant Pleural Effusion.
Patients with metastatic cancer often have fluid collecting around the lung as a result of
cancer cells spreading to the membranes adjacent to the lung (malignant pleural effusion).
The standard way of treating this condition, which may cause unpleasant symptoms such as
breathlessness and cough, is to drain the fluid off and then seal the cavity, using a drug
(talc) given into the chest drain. Talc causes inflammation in the lining of the lung and
chest wall, sticking the two surfaces together and preventing fluid from recurring. This
procedure is often very painful; the pain may be partly related to the size of the chest
tube used and the type of analgesia taken by the patient during the procedure. Reducing the
amount of pain associated with this procedure would be a substantial benefit for patients
undergoing this procedure.
This trial is looking at which of two different drug regimens is more effective in
preventing pleurodesis pain, and whether the size of chest tube influences pain. It will
also address whether either of these influences success rate of pleurodesis.
We hope to learn whether the size of chest drain or the type of pain medication given
(ibuprofen or morphine) influences the amount of pain felt after the pleurodesis procedure.
We hope to find the best way of preventing pain during this procedure.
Inclusion Criteria:
1. Clinically confident diagnosis of malignant pleural effusion requiring pleurodesis.
The diagnosis may be established by one of:
- Histologically proven pleural malignancy OR
- Typical features of pleural malignancy seen on direct vision during thoracoscopy
OR
- Pleural effusion in the context of histologically proven cancer elsewhere
2. Expected survival more than 1 month
3. Written informed consent
Exclusion Criteria:
1. Age < 18 years
2. Primary lymphoma or small cell lung carcinoma
3. Patients who are pregnant or lactating
4. Inability to give informed consent
5. History of GI bleeding or of untreated peptic ulceration
6. Known sensitivity to non-steroidal anti-inflammatory drugs
(NSAIDs)/opiates/acetaminophen
7. Hypercapnic respiratory failure
8. Known intravenous drug abuse
9. Severe renal or liver disease
10. Known bleeding diathesis
11. Warfarin therapy
12. Current or recent (within 2 weeks) corticosteroid steroid therapy
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
An average pain score over 72 hours post pleurodesis for malignant pleural effusion
Outcome Time Frame:
72 hours
Safety Issue:
No
Principal Investigator
RJO Davies, Dr.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Oxford Pleural Unit, Churchill Hospital, Oxford, England
Authority:
United States: Institutional Review Board
Study ID:
200816478
NCT ID:
NCT00896285
Start Date:
April 2009
Completion Date:
July 2011
Related Keywords:
- Malignant Pleural Effusion
- Pleural Effusion
- Pleural malignancy
- pleural effusion
- pleurodesis
- chest tube
- cancer
- cancer pain management
- Pleural Effusion
- Pleural Effusion, Malignant
Name | Location |
|---|---|
| UC Davis Medical Center | Sacramento, California 95817 |
