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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Diclofenac; Drug: parecoxib/ valdecoxib; Device: patient controlled epidural analgesia

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland
    • Helsinki University Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain intensity 6 months after surgery	The primary outcome when comparing the Intervention and Control groups was pain intensity 6 months after surgery.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
consumption of PCA-morphine	consumption of PCA-morphine in groups 1 and 2	4 days
pain intensity while coughing	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)	4 days
adverse effects	adverse effects (e.g. nausea, itching, sedation and subjective tiredness) measured with VAS 0-10 cm	1-7 days

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Collaborators: Academy of Finland
• Investigators: Principal Investigator: Elina Tiippana, M.D., Helsinki University Central Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2004
• Primary Completion (Actual): September 1, 2008
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: February 18, 2012
• First Submitted That Met QC Criteria: February 28, 2012
• First Posted (Estimate): February 29, 2012

Study Record Updates

• Last Update Posted (Estimate): February 29, 2012
• Last Update Submitted That Met QC Criteria: February 28, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: PCA; pain; chronic; NSAID; thoracotomy; TEA
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Diclofenac; Valdecoxib; Parecoxib
• Other Study ID Numbers: 74555