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
  Purpose

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.


Condition Intervention
Postoperative Pain
Drug: Diclofenac
Drug: parecoxib/ valdecoxib
Device: patient controlled epidural analgesia

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: NSAID With IV-PCA Morphine is an Alternative to Thoracic Epidural Analgesia in Post-thoracotomy Pain

Resource links provided by NLM:


Further study details as provided by Helsinki University Central Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 30
Study Start Date: March 2004
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
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
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
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
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01541137

Locations
Finland
Helsinki University Central Hospital
Helsinki, Finland
Sponsors and Collaborators
Helsinki University Central Hospital
Academy of Finland
Investigators
Principal Investigator: Elina Tiippana, M.D. Helsinki University Central Hospital
  More Information

No publications provided

Responsible Party: Elina Tiippana, MD, M.D., Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT01541137     History of Changes
Other Study ID Numbers: 74555
Study First Received: February 18, 2012
Last Updated: February 28, 2012
Health Authority: Finland: Ethics Committee
Finland: Finnish Medicines Agency

Keywords provided by Helsinki University Central Hospital:
thoracotomy
pain
NSAID
PCA
TEA
chronic

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Anti-Inflammatory Agents, Non-Steroidal
Diclofenac
Valdecoxib
Parecoxib
Morphine
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Analgesics, Opioid
Central Nervous System Depressants
Narcotics
Cyclooxygenase 2 Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014