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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Narcotics
Central Nervous System Depressants
Cyclooxygenase 2 Inhibitors

ClinicalTrials.gov processed this record on September 11, 2014