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Fluid caused by cancer cells may accumulate in the lining of the lung. Draining the fluid with a chest tube may relieve pain and shortness of breath. To stop the fluid from coming back again, patients are given a medicine (talc) into the chest drain to seal up the space around the lung. This procedure is known as pleurodesis. This sometimes causes pain and discomfort, and the investigators do not know the best way of preventing this.
The investigators hope to find the best way to prevent pain during pleurodesis.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator |
| |
| 2 | Active Comparator |
| |
| 3 | Active Comparator |
| |
| 4 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Large bore chest drain + NSAID based analgesic regimen | Other | Chest tube greater than 14 French size and ibuprofen. |
|
| Measure | Description | Time Frame |
|---|---|---|
| An average pain score over 72 hours post pleurodesis for malignant pleural effusion | 72 hours | |
| Pleurodesis success at 3 months post randomization (time to relapse of pleural effusion) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of chronic chest pain on the side of the pleurodesis | 6 weeks | |
| Presence of chronic chest pain on the side of the pleurodesis | 6 months |
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Inclusion Criteria:
Clinically confident diagnosis of malignant pleural effusion requiring pleurodesis. The diagnosis may be established by one of:
Expected survival more than 1 month
Written informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| RJO Davies, Dr. | Oxford Pleural Unit, Churchill Hospital, Oxford, England | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Davis Medical Center | Sacramento | California | 95817 | United States |
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| Small bore chest drain + NSAID based analgesic regimen | Other | Chest tube less than or equal to 14 French size and ibuprofen. |
|
| Large bore chest drain + opiate based analgesic regimen | Other | Chest tube greater than 14 French size and morphine. |
|
| Small bore chest drain + opiate based analgesic regimen | Other | Chest tube less than or equal to 14 French size and morphine. |
|
| ID | Term |
|---|---|
| D016066 | Pleural Effusion, Malignant |
| D010996 | Pleural Effusion |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D010997 | Pleural Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
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