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NCT Number: NCT01541137

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

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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Key information

Conditions

Postoperative Pain Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Graft vs Host Disease Immune System Diseases Lung Diseases Lung Diseases, Obstructive Neurologic Manifestations Organizing Pneumonia Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Respiratory Tract Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helsinki University Central Hospital

Helsinki, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

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

Primary outcomes

  1. 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

  1. consumption of PCA-morphine

    Time frame: 4 days

    consumption of PCA-morphine in groups 1 and 2

  2. pain intensity while coughing

    Time frame: 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)

  3. adverse effects

    Time frame: 1-7 days

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

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Collaborators

  • Academy of Finland

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Feb 29, 2012
Registry last updated
Feb 29, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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