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

NCT01541137 | Completed

• 1 other identifier: 74555
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pain

Keywords

thoracotomy; pain; NSAID; PCA; TEA; chronic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• consumption of PCA-morphine

  4 days

• pain intensity while coughing

  4 days

• adverse effects

  1-7 days

Study Arms (3)

diclofenac + IV-PCA

ACTIVE COMPARATOR

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

parecoxib/ valdecoxib + IV-PCA

ACTIVE COMPARATOR

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

patient controlled epidural analgesia

ACTIVE COMPARATOR

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

Interventions

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

diclofenac + IV-PCA

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

parecoxib/ valdecoxib + IV-PCA

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

patient controlled epidural analgesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for elective thoracotomy for lung surgery

You may not qualify if:

• 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).

Sponsors & Collaborators

• Helsinki University Central Hospital: lead
• Academy of Finland: collaborator

Study Sites (1)

Helsinki University Central Hospital

Helsinki, Finland

Location

MeSH Terms

Conditions

Pain, Postoperative; Pain; Bronchiolitis Obliterans Syndrome

Interventions

Diclofenac; parecoxib; valdecoxib

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Elina Tiippana, M.D.

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: February 18, 2012
• First Posted: February 29, 2012
• Study Start: March 1, 2004
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: February 29, 2012

Record last verified: 2012-02

Locations

FI (1)