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Effect of Paracetamol, Pregabalin and Dexamethasone on Pain and Opioid Requirements in Patients After Hip Operations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00235261
Recruitment Status : Completed
First Posted : October 10, 2005
Last Update Posted : August 17, 2007
Information provided by:
Glostrup University Hospital, Copenhagen

Brief Summary:
Patients scheduled for primary total hip replacement needs postoperative pain treatment: i.e. morphine. Unfortunately morphine has side-effects: nausea, vomiting, sedation and dizziness, which is unpleasant for the patients and sometimes keeps them at bed longer time than needed. We investigate in new combinations of analgesics for postoperative pain, hoping to minimize the need for morphine and improve the patients pain score after operation.

Condition or disease Intervention/treatment Phase
Pain Postoperative Drug: Pregabalin Drug: Dexamethasone Phase 4

Detailed Description:
We investigate the effect of paracetamol versus paracetamol + pregabalin versus paracetamol + pregabalin + dexamethasone on pain and morphine usage in the first 24 hours postoperatively in patients getting a new hip alloplastic.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Effect of Paracetamol Versus Paracetamol Combined With Pregabalin Versus Paracetamol Combined With Pregabalin and Dexamethasone on Pain and Opioid Requirements in Patients Scheduled for a Primary Total Hip Replacement
Study Start Date : October 2005
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. The total amount of morphine needed postoperatively from 0-4 h, and 0-24 h, administered by a patient controlled pain treatment. (PCA)

Secondary Outcome Measures :
  1. Pain score (VAS) at rest and at mobilisation.
  2. Postoperative nausea and vomiting.
  3. Sedation.
  4. Dizziness
  5. All measurements are taken at 2,4 and 24 h postoperatively

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients scheduled for primary total hip replacement in spinal anaesthesia
  • between the age of 55 and 75,
  • ASA 1-3, and with
  • BMI between 18 and 35.

Exclusion Criteria:

  • are unable to cooperate;
  • does not speak Danish;
  • has allergy for drugs used in the trial;
  • has drug and/or medicine abuse;
  • epilepsy;
  • diabetes treated with medicine;
  • treatment with systemic steroids within 4 weeks prior to the operation;
  • daily use of antacids;
  • daily use of analgesics except for NSAID, Cox2 inhibitors and Paracetamol;
  • known kidney disease;
  • use of antidepressants

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 identifier (NCT number): NCT00235261

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Department of anaesthesiology; Hoersholm Sygehus
Hoersholm, Frederiksborg Amt, Denmark, 2970
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
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Study Chair: Ole Mathiesen, MD Department of Anaesthesiology, Copenhagen University Hospital in Glostrup, 2600 Glostrup, Denmark
Principal Investigator: Lars Steen Jacobsen, MD Departmentof Anaesthesiology; Hørsholm Sygehus; Usserød Kongevej 102; 2970 Hørsholm; Denmark
Layout table for additonal information Identifier: NCT00235261    
Other Study ID Numbers: SM3-05
First Posted: October 10, 2005    Key Record Dates
Last Update Posted: August 17, 2007
Last Verified: August 2007
Keywords provided by Glostrup University Hospital, Copenhagen:
Total hip replacement
Multimodal postoperative analgesia.
Additional relevant MeSH terms:
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Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Sensory System Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs