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

This study has been completed.
Sponsor:
Collaborator:
Academy of Finland
Information provided by (Responsible Party):
Elina Tiippana, MD, Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT01541137
First received: February 18, 2012
Last updated: February 28, 2012
Last verified: February 2012

February 18, 2012
February 28, 2012
March 2004
September 2008   (final data collection date for primary outcome measure)
pain intensity 6 months after surgery [ Time Frame: 6 months ] [ Designated as safety issue: No ]
The primary outcome when comparing the Intervention and Control groups was pain intensity 6 months after surgery.
Same as current
Complete list of historical versions of study NCT01541137 on ClinicalTrials.gov Archive Site
  • consumption of PCA-morphine [ Time Frame: 4 days ] [ Designated as safety issue: Yes ]
    consumption of PCA-morphine in groups 1 and 2
  • pain intensity while coughing [ Time Frame: 4 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1-7 days ] [ Designated as safety issue: Yes ]
    adverse effects (e.g. nausea, itching, sedation and subjective tiredness) measured with VAS 0-10 cm
Same as current
Not Provided
Not Provided
 
NSAIDs With Morphine-PCA Compared to Epidural Analgesia in Thoracotomy Pain
NSAID With IV-PCA Morphine is an Alternative to Thoracic Epidural Analgesia in Post-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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Postoperative Pain
  • Drug: Diclofenac
    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
  • Drug: parecoxib/ 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
  • Device: patient controlled epidural analgesia
    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
  • Active Comparator: 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: Drug: Diclofenac
  • Active Comparator: 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: Drug: parecoxib/ valdecoxib
  • Active Comparator: 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: Device: patient controlled epidural analgesia
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
September 2008
September 2008   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT01541137
74555
No
Elina Tiippana, MD, Helsinki University Central Hospital
Helsinki University Central Hospital
Academy of Finland
Principal Investigator: Elina Tiippana, M.D. Helsinki University Central Hospital
Helsinki University Central Hospital
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP