Postoperative Pain
Conditions
Keywords
thoracotomy, pain, NSAID, PCA, TEA, chronic
Brief summary
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.
Interventions
DRUGDiclofenac
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
DRUGparecoxib/ valdecoxib
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
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
Sponsors
Academy of Finland
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients scheduled for elective thoracotomy for lung surgery
Exclusion criteria
* Contraindication to any of the study drugs or an epidural catheter, * Significant liver, renal or cardiac disease * Peptic ulcer * Regular use of analgesics * Re-thoracotomy, and the patient´s inability to understand the use of PCA/patient controlled thoracic epidural analgesia (PCEA).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pain intensity 6 months after surgery | 6 months | The primary outcome when comparing the Intervention and Control groups was pain intensity 6 months after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| consumption of PCA-morphine | 4 days | consumption of PCA-morphine in groups 1 and 2 |
| pain intensity while coughing | 4 days | 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) |
| adverse effects | 1-7 days | adverse effects (e.g. nausea, itching, sedation and subjective tiredness) measured with VAS 0-10 cm |
Countries
Finland
Outcome results
None listed