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

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Diclofenac
parecoxib/ valdecoxib
patient controlled epidural analgesia
Sponsored by
Helsinki University Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring thoracotomy, pain, NSAID, PCA, TEA, chronic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Helsinki University Central Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

diclofenac + IV-PCA

parecoxib/ valdecoxib + IV-PCA

patient controlled epidural analgesia

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

pain intensity 6 months after surgery
The primary outcome when comparing the Intervention and Control groups was pain intensity 6 months after surgery.

Secondary Outcome Measures

consumption of PCA-morphine
consumption of PCA-morphine in groups 1 and 2
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)
adverse effects
adverse effects (e.g. nausea, itching, sedation and subjective tiredness) measured with VAS 0-10 cm

Full Information

First Posted
February 18, 2012
Last Updated
February 28, 2012
Sponsor
Helsinki University Central Hospital
Collaborators
Academy of Finland
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1. Study Identification

Unique Protocol Identification Number
NCT01541137
Brief Title
NSAIDs With Morphine-PCA Compared to Epidural Analgesia in Thoracotomy Pain
Official Title
NSAID With IV-PCA Morphine is an Alternative to Thoracic Epidural Analgesia in Post-thoracotomy Pain
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital
Collaborators
Academy of Finland

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
thoracotomy, pain, NSAID, PCA, TEA, chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
diclofenac + IV-PCA
Arm Type
Active Comparator
Arm Description
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
Arm Title
parecoxib/ valdecoxib + IV-PCA
Arm Type
Active Comparator
Arm Description
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
Arm Title
patient controlled epidural analgesia
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Diclofenac
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
parecoxib/ valdecoxib
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
patient controlled epidural analgesia
Intervention Description
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
Primary Outcome Measure Information:
Title
pain intensity 6 months after surgery
Description
The primary outcome when comparing the Intervention and Control groups was pain intensity 6 months after surgery.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
consumption of PCA-morphine
Description
consumption of PCA-morphine in groups 1 and 2
Time Frame
4 days
Title
pain intensity while coughing
Description
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)
Time Frame
4 days
Title
adverse effects
Description
adverse effects (e.g. nausea, itching, sedation and subjective tiredness) measured with VAS 0-10 cm
Time Frame
1-7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elina Tiippana, M.D.
Organizational Affiliation
Helsinki University Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helsinki University Central Hospital
City
Helsinki
Country
Finland

12. IPD Sharing Statement

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

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