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

This study has been completed.
Sponsor:
Information provided by:
Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier:
NCT00235261
First received: October 6, 2005
Last updated: August 16, 2007
Last verified: August 2007
History of Changes
  Purpose

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 Intervention Phase
Pain
Postoperative
 Drug: Pregabalin
Drug: Dexamethasone
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Glostrup University Hospital, Copenhagen:

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

Estimated Enrollment: 120
Study Start Date: October 2005
Study Completion Date: June 2007
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.

  Eligibility

Ages Eligible for Study:   55 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00235261

Locations
Denmark
Department of anaesthesiology; Hoersholm Sygehus
Hoersholm, Frederiksborg Amt, Denmark, 2970
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
Investigators
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00235261     History of Changes
Other Study ID Numbers: SM3-05
Study First Received: October 6, 2005
Last Updated: August 16, 2007
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Medicines Agency
Denmark: Danish Dataprotection Agency

Keywords provided by Glostrup University Hospital, Copenhagen:
Total hip replacement
Pregablin
Dexamethasone
Multimodal postoperative analgesia.

Additional relevant MeSH terms:
Acetaminophen
Pregabalin
Dexamethasone
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Analgesics, Opioid
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
 Therapeutic Uses
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Depressants
Anticonvulsants

ClinicalTrials.gov processed this record on May 23, 2013