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Clinical Trials/NCT01541137
NCT01541137
Completed
Not Applicable

NSAID With IV-PCA Morphine is an Alternative to Thoracic Epidural Analgesia in Post-thoracotomy Pain

Helsinki University Central Hospital1 site in 1 country30 target enrollmentMarch 2004

Overview

Phase
Not Applicable
Intervention
Diclofenac
Conditions
Postoperative Pain
Sponsor
Helsinki University Central Hospital
Enrollment
30
Locations
1
Primary Endpoint
pain intensity 6 months after surgery
Status
Completed
Last Updated
14 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2004
End Date
September 2008
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Elina Tiippana, MD

M.D.

Helsinki University Central Hospital

Eligibility Criteria

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).

Arms & Interventions

diclofenac + IV-PCA

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

Intervention: Diclofenac

parecoxib/ valdecoxib + IV-PCA

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

Intervention: parecoxib/ valdecoxib

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

Intervention: patient controlled epidural analgesia

Outcomes

Primary Outcomes

pain intensity 6 months after surgery

Time Frame: 6 months

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

Secondary Outcomes

  • consumption of PCA-morphine(4 days)
  • pain intensity while coughing(4 days)
  • adverse effects(1-7 days)

Study Sites (1)

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