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| Name | Class |
|---|---|
| Academy of Finland | OTHER |
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The investigators investigated whether a strictly controlled pain management with patients participating in a clinical study can attenuate persistence of post-thoracotomy pain. The investigators also wanted to find out whether NSAID + intravenous patient-controlled analgesia with morphine is an efficacious alternative to thoracic epidural analgesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| diclofenac + IV-PCA | Active Comparator | oral diclofenac 75 mg, a 44-hour iv-infusion of diclofenac 150 mg/24h, intercostal nerve block with 20 ml of 0.5% bupivacaine, IV-PCA programmed with morphine boluses, from the 2nd postoperative morning the patients were given oral diclofenac 75 mg x 2, IV-PCA-morphine was discontinued after removal of pleural drains, and the patients were given oral oxycodone |
|
| parecoxib/ valdecoxib + IV-PCA | Active Comparator | oral valdecoxib 40 mg, a 44-hour iv-infusion parecoxib 80 mg/24h, intercostal nerve block with 20 ml of 0.5% bupivacaine, IV-PCA programmed with morphine, From the 2nd postoperative morning valdecoxib 40 mg x 2, IV-PCA-morphine was discontinued after removal of pleural drains, and the patients were given oral oxycodone |
|
| patient controlled epidural analgesia | Active Comparator | At the induction of anesthesia the PCEA-patients were given IV paracetamol 1g and an epidural loading dose of 1 ml/10 kg of 0.15% bupivacaine with fentanyl 6 µg/ml. Thereafter a continuous infusion was started at 1 ml/10 kg/h. In the PACU PCEA-patients could take incremental doses, IV paracetamol 1g x 4 for the first 24 hours and thereafter 1g x 3 orally, PCEA was discontinued and paracetamol was replaced with ibuprofen 600 mg x 3 and oral oxycodone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diclofenac | Drug | oral diclofenac 75 mg, a 44-hour iv-infusion of diclofenac 150 mg/24h, oral diclofenac 75 mg x 2, IV-PCA programmed with morphine boluses of 2-3 mg and a lock-out time of 5-15 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| pain intensity 6 months after surgery | The primary outcome when comparing the Intervention and Control groups was pain intensity 6 months after surgery. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| consumption of PCA-morphine | consumption of PCA-morphine in groups 1 and 2 | 4 days |
| pain intensity while coughing | pain intensity while coughing during the first four postoperative days using VAS (visual analogue scale) 0-10 cm (0 = no pain and 10 = worst imaginable pain) or NRS in the PACU (numeric rating scale, 0-10) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elina Tiippana, M.D. | Helsinki University Central Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University Central Hospital | Helsinki | Finland |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D010146 | Pain |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D004008 | Diclofenac |
| C409945 | parecoxib |
| C406224 | valdecoxib |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| parecoxib/ valdecoxib | Drug | oral valdecoxib 40 mg, a 44-hour iv-infusion of parecoxib 80 mg/24h, IV-PCA programmed with morphine boluses of 2-3 mg and a lock-out time of 5-15 minutes |
|
| patient controlled epidural analgesia | Device | epidural catheter, epidural loading dose of 1 ml/10 kg of 0.15% bupivacaine with fentanyl 6 µg/ml. Thereafter a continuous infusion was started at 1 ml/10 kg/h. In the PACU PCEA-patients could take incremental doses of 3 ml with a 8-15 min lock-out time |
|
| 4 days |
| adverse effects | adverse effects (e.g. nausea, itching, sedation and subjective tiredness) measured with VAS 0-10 cm | 1-7 days |
| D012816 | Signs and Symptoms |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |