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

Postoperative Pain Clinical Trial

Official title:

NSAID With IV-PCA Morphine is an Alternative to Thoracic Epidural Analgesia in Post-thoracotomy Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01541137
• Other study ID #: 74555
• Status: Completed
• Phase: N/A
• First received: February 18, 2012
• Last updated: February 28, 2012
• Start date: March 2004
• Est. completion date: September 2008

Study information

• Verified date: February 2012
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics CommitteeFinland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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
• 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

Locations

Country	Name	City	State
Finland	Helsinki University Central Hospital	Helsinki

Sponsors (2)

Lead Sponsor	Collaborator
Helsinki University Central Hospital	Academy of Finland

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	consumption of PCA-morphine	consumption of PCA-morphine in groups 1 and 2	4 days	Yes
Secondary	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	No
Secondary	adverse effects	adverse effects (e.g. nausea, itching, sedation and subjective tiredness) measured with VAS 0-10 cm	1-7 days	Yes