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PAracetamol and NSAID in Combination: A Randomised, Blinded, Parallel, 4-group Clinical Trial (PANSAID)

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ClinicalTrials.gov Identifier: NCT02571361
Recruitment Status : Completed
First Posted : October 8, 2015
Last Update Posted : February 12, 2018
Sponsor:
Collaborator:
Copenhagen Trial Unit, Center for Clinical Intervention Research
Information provided by (Responsible Party):
Daniel Hägi-Pedersen, Naestved Hospital

Brief Summary:

Trial name: PAracetamol and NSAID in combination: A randomised, blinded, parallel, 4-group clinical trial

Trial acronym: PANSAID

Background: Effective postoperative pain management is essential for the well-being and rehabilitation of the surgical patient. No "gold standard" exists after total hip arthroplasty (THA) and combinations of different non-opioid medications are used with virtually no evidence for additional analgesic efficacy compared to monotherapy.

Objectives: The objective of this trial is to investigate the analgesic effects and safety of paracetamol and ibuprofen and their combination in different dosages after THA.

Intervention: Patients are randomised to 4 groups: A) paracetamol 1 g x 4 and ibuprofen 400 mg x 4; B) paracetamol 1 g x 4 and placebo (ibuprofen); C) placebo (paracetamol) and ibuprofen 400 mg x 4; and D) paracetamol 0,5 g x 4 and ibuprofen 200 mg.

Design: Placebo controlled, parallel 4-group, multicentre trial with adequate centralised computer-generated allocation sequence and allocation concealment with varying block size and stratification by site. Blinding of assessor, investigator, caregivers, patients, and statisticians.

Sample size: 556 eligible patients are needed to detect a difference of 10 mg morphine the first postoperative day with a standard deviation of 20 mg and a type 1 error rate of 0,004 (two-sided) and a type 2 error rate of 0,10.


Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: Paracetamol (1g x 4) Drug: Ibuprofen (400 mg x 4) Drug: Paracetamol (0,5 g x 4) Drug: Ibuprofen (200 mg x 4) Drug: Placebo (x4) Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 556 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: PAracetamol and NSAID in Combination: A Randomised, Blinded, Parallel, 4-group Clinical Trial
Study Start Date : November 2015
Actual Primary Completion Date : October 2017
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Treatment A:
Paracetamol 1g + ibuprofen 400 mg orally starting 1 hour before surgery and given with 6-hour intervals (+/- 1 hour) i.e. a total of 4 times the first 24 hours postoperative.
Drug: Paracetamol (1g x 4)
Dose of 1 g given in 6 hour intervals the first 24 hours postoperatively
Other Name: Acetaminophen

Drug: Ibuprofen (400 mg x 4)
Dose of 400 mg given in 6 hour intervals the first 24 hours postoperatively

Active Comparator: Treatment B:
Paracetamol 1g + placebo orally starting 1 hour before surgery and given with 6-hour intervals (+/- 1 hour) i.e. a total of 4 times the first 24 hours postoperative.
Drug: Paracetamol (1g x 4)
Dose of 1 g given in 6 hour intervals the first 24 hours postoperatively
Other Name: Acetaminophen

Drug: Placebo (x4)
Given in 6 hour intervals the first 24 hours postoperatively

Active Comparator: Treatment C:
Placebo + ibuprofen 400 mg orally starting 1 hour before surgery and given with 6-hour intervals (+/- 1 hour) i.e. a total of 4 times the first 24 hours postoperative.
Drug: Ibuprofen (400 mg x 4)
Dose of 400 mg given in 6 hour intervals the first 24 hours postoperatively

Drug: Placebo (x4)
Given in 6 hour intervals the first 24 hours postoperatively

Active Comparator: Treatment D:
Paracetamol 0,5 g + ibuprofen 200 mg orally starting 1 hour before surgery and given with 6-hour intervals (+/- 1 hour) i.e. a total of 4 times the first 24 hours postoperative.
Drug: Paracetamol (0,5 g x 4)
Dose of 0,5 g given in 6 hour intervals the first 24 hours postoperatively
Other Name: Acetaminophen

Drug: Ibuprofen (200 mg x 4)
Dose of 200 mg given in 6 hour intervals the first 24 hours postoperatively




Primary Outcome Measures :
  1. Morphine consumption the first 24 hours postoperatively [ Time Frame: 0-24 hours postoperatively ]
    Total need for morphine administered as BOTH patient controlled analgesia (PCA) for the first 24 hours postoperatively AND supplemental morphine administered at the post-anaesthesia unit the first hour postoperatively. Bolus 2.0 mg; lockout: 10 min

  2. Serious adverse events [ Time Frame: 0-90 days postoperatively ]
    Serious adverse events, including death, within 90 days after surgery defined as SAE (according to ICH-GCP-guidelines) except "prolongation of hospitalisation"


Secondary Outcome Measures :
  1. Pain during movement at 6 hours postoperatively (visual analogue scale) [ Time Frame: 6 hours postoperatively ]
    Pain scores (visual analogue scale (VAS)) with active 30 degrees flexion of the hip at 6 hours postoperatively. No pain = 0; worst imaginable pain = 100

  2. Pain during movement at 24 hours postoperatively (visual analogue scale) [ Time Frame: 24 hours postoperatively ]
    Pain scores (visual analogue scale (VAS)) with active 30 degrees flexion of the hip at 24 hours postoperatively. No pain = 0; worst imaginable pain = 100

  3. Pain at rest at 6 hours postoperatively (visual analogue scale) [ Time Frame: 6 hours postoperatively ]
    Pain scores (visual analogue scale (VAS)) at rest at 6 hours postoperatively. No pain = 0; worst imaginable pain = 100

  4. Pain at rest at 24 hours postoperatively (visual analogue scale) [ Time Frame: 24 hours postoperatively ]
    Pain scores (visual analogue scale (VAS)) at rest at 24 hours postoperatively. No pain = 0; worst imaginable pain = 100

  5. Adverse events [ Time Frame: 0-24 hours postoperatively ]
    Number of patients with one or more adverse events in the intervention period (0-24 hours)


Other Outcome Measures:
  1. Nausea at 6 hours postoperatively (Verbal rating scale) [ Time Frame: 6 hours postoperatively ]
    Level of nausea at 6 hours postoperatively. Verbal rating scale: none, mild, moderate or severe

  2. Nausea at 24 hours postoperatively (Verbal rating scale) [ Time Frame: 24 hours postoperatively ]
    Level of nausea at 24 hours postoperatively. Verbal rating scale: none, mild, moderate or severe

  3. Vomiting the first 24 hours postoperatively [ Time Frame: 0-24 hours postoperatively ]
    Number of vomiting episodes (0-24 hours) measured in the periods 0-6 and 6-24 hours postoperatively

  4. Anti-emetic treatment the first 24 hours postoperatively [ Time Frame: 0-24 hours postoperatively ]
    Consumption of ondansetron in the period 0-24 hours postoperatively

  5. Sedation at 6 hours postoperatively (Verbal rating scale) [ Time Frame: 6 hours postoperatively ]
    Level of sedation at 6 hours postoperatively. Verbal rating scale: none, mild, moderate or severe

  6. Sedation at 24 hours postoperatively (Verbal rating scale) [ Time Frame: 24 hours postoperatively ]
    Level of sedation at 24 hours postoperatively. Verbal rating scale: none, mild, moderate or severe

  7. Blood loss intraoperatively [ Time Frame: intraoperatively ]
    Blood loss during the surgical procedure (intraoperatively)

  8. Days alive and outside hospital within 90 days after surgery. [ Time Frame: 0-90 days postoperatively ]
    Days alive and outside hospital within 90 days after surgery.

  9. Dizziness at 6 hours postoperatively (Verbal rating scale) [ Time Frame: 6 hours postoperatively ]
    Level of dizziness at 6 hours postoperatively. Verbal rating scale: none, mild, moderate or severe

  10. Dizziness at 24 hours postoperatively (Verbal rating scale) [ Time Frame: 24 hours postoperatively ]
    Level of dizziness at 24 hours postoperatively. Verbal rating scale: none, mild, moderate or severe



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Scheduled for unilateral, primary Total Hip Arthroplasty (THA)
  • Age > 18
  • ASA 1-3.
  • BMI > 18 and < 40
  • Women in the fertile age must have negative urine HCG pregnancy test
  • Patients who gave their written informed consent to participating in the trial after having fully understood the contents of the protocol and restrictions.

Exclusion Criteria:

  • Patients who cannot cooperate with the trial.
  • Concomitant participation in another trial
  • Patients who cannot understand or speak Danish.
  • Daily use of strong opioids (tramadol and codein are accepted)
  • Patients with allergy to the medicines used in the trial.
  • Contraindications against NSAID, for example previous ulcer, heart failure, liver failure, or renal failure (eGRF < 60 ml/kg/1,73m2), known thrombocytopenia (<100 mia/L)
  • Patients suffering from alcohol and/or drug abuse - based on the investigator's judgement.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02571361


Locations
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Denmark
Gildhøj Privathospital
København, Brøndby, Denmark, 2605
Holbæk Hospital
Holbæk, Denmark, 4300
Køge Hospital
Køge, Denmark, 4600
Nykøbing Falster Hospital
Nykøbing Falster, Denmark, 4800
Næstved Hospital
Næstved, Denmark, 4700
Odense University Hospital (OUH)
Odense, Denmark, 5000
Sponsors and Collaborators
Daniel Hägi-Pedersen
Copenhagen Trial Unit, Center for Clinical Intervention Research
Investigators
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Study Chair: Daniel Hägi-Pedersen, MD, PhD Department of Anaesthesiology, Næstved Hospital
Principal Investigator: Kasper H Thybo, MD Department of Anaesthesiology, Næstved Hospital
Study Chair: Ole Mathiesen, MD, PhD Department of Anaesthesiology, Køge Hospital
Study Chair: Jørgen B Dahl, MD, DMSc Department of Anaesthesiology, Bispebjerg Hospital
Study Chair: Jørn Wetterslev, MD, PhD Copenhagen Trial Unit, Center for Clinical Intervention Research
Study Chair: Martin Pohlman, MD Department of Anaesthesiology, Nykøbing Falster Hospital
Study Chair: Hans Henrik Bülow, MD Department of Anaesthesiology, Holbæk Hospital

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Daniel Hägi-Pedersen, Consultant, Naestved Hospital
ClinicalTrials.gov Identifier: NCT02571361     History of Changes
Other Study ID Numbers: SM2-KHT-2015 - v2
2015-002239-16 ( EudraCT Number )
First Posted: October 8, 2015    Key Record Dates
Last Update Posted: February 12, 2018
Last Verified: February 2018

Keywords provided by Daniel Hägi-Pedersen, Naestved Hospital:
Acetaminophen
Ibuprofen
Arthroplasty, Replacement, Hip

Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Acetaminophen
Ibuprofen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action