NSAIDs With Morphine-PCA Compared to Epidural Analgesia in Thoracotomy Pain

Helsinki University Central Hospital30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Postoperative Pain

Interventions

DiclofenacDRUG

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

parecoxib/ valdecoxibDRUG

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 analgesiaDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (1)

Helsinki University Central Hospital

Helsinki, Finland

Outcomes

Primary Outcomes

pain intensity 6 months after surgery

The primary outcome when comparing the Intervention and Control groups was pain intensity 6 months after surgery.

Time frame: 6 months

Secondary Outcomes

consumption of PCA-morphine

consumption of PCA-morphine in groups 1 and 2

Time frame: 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)

Time frame: 4 days

adverse effects

adverse effects (e.g. nausea, itching, sedation and subjective tiredness) measured with VAS 0-10 cm

Time frame: 1-7 days

Data from ClinicalTrials.gov

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