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

Not Applicable

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: parecoxib/ valdecoxib; Device: patient controlled epidural analgesia; Drug: Diclofenac

• Registration Number: NCT01541137
• Lead Sponsor: Helsinki University Central Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-03
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Status Verified: 2012-02
• Study First Submitted: 2012-02-18
• Study First Submitted QC: 2012-02-28
• Last Update Submitted: 2012-02-28
• Study First Posted: 2012-02-29
• Last Update Posted: 2012-02-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
parecoxib/ valdecoxib + IV-PCA	parecoxib/ valdecoxib	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	patient controlled epidural analgesia	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
diclofenac + IV-PCA	Diclofenac	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Helsinki University Central Hospital; 🇫🇮 Helsinki, Finland