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The Effect of Gabapentin, Ketamine and Dexamethasone on Pain and Opioid Requirements After Hip Surgery

This study has been terminated.
(Structural changes that stopped the type of operations used in the study)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00236223
First Posted: October 12, 2005
Last Update Posted: May 15, 2008
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.
Information provided by:
Glostrup University Hospital, Copenhagen
  Purpose
Patients scheduled for primary hip replacement needs postoperative pain treatment, i.e. morphine. Morphine has side-effects: nausea, vomiting, sedation and dizziness. These side-effects are 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.

Condition Intervention Phase
Pain, Postoperative Drug: Gabapentin + dexamethasone + ketamine Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Gabapentin, Low Dose Ketamine, Paracetamol, NSAID and Dexamethasone on Pain and Opioid Requirements in Patients Scheduled for Primary Total Hip Replacement

Resource links provided by NLM:


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

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

Secondary Outcome Measures:
  • Pain score (VAS)= at rest and at mobilisation. [ Time Frame: 0-24h ]
  • Postoperative Nausea and vomiting. [ Time Frame: 0-24h ]
  • Dizziness [ Time Frame: 0-24h ]
  • Sedation [ Time Frame: 0-24h ]
  • Nightmare and hallucinations. [ Time Frame: 0-24h ]
  • All measurements are taken at 2,4 and 24 h postoperatively. [ Time Frame: 0-24h ]

Enrollment: 48
Study Start Date: October 2005
Study Completion Date: May 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Gabapentin + dexamethasone + ketamine
Comparing analgesic effect of gabapentin 1200 mg + dexamethasone 8 mg + ketamine 0.15 mg/kg
Other Names:
  • Anti-hyperalgesics
  • Postoperative pain
Placebo Comparator: 2 Drug: Placebo
Matching placebo

Detailed Description:
The effect on postoperative pain of the combination of preoperative gabapentin 1200 mg + dexamethasone 8 mg + ketamine 0.15mg/kg versus placebo is investigated on patients having a hip alloplastic operation.
  Eligibility

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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients scheduled for primary total hip replacement,
  • Between 55 and 85 years of age,
  • ASA 1-3 and BMI between 18 and 35.

Exclusion Criteria:

Patients who are:

  • Unable to cooperate
  • Does not speak Danish
  • Has allergy for drugs used in the trial
  • Drug or alcohol abuse
  • Epilepsy
  • Medically treated diabetes
  • Known kidney disease
  • Daily use of analgetics
  • Apart from NSAID
  • Paracetamol or COX2 inhibitors
  • Are treated with a antidepressive.
  Contacts and Locations
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): NCT00236223


Locations
Denmark
Operations og Anæstesiologisk afd. Y, KAS Glostrup
Glostrup, Denmark, 2600
Anæstesiafdelingen, Herning Centralsygehus
Herning, Denmark, 7400
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
Investigators
Principal Investigator: Ole Mathiesen, MD Department of Anaesthesiology, Copenhagen University Hospital in Glostrup, 2600 Glostrup, Denmark
  More Information

Responsible Party: Ole Mathiesen, Dept of anaesthesiology
ClinicalTrials.gov Identifier: NCT00236223     History of Changes
Other Study ID Numbers: SM2-05
First Submitted: October 7, 2005
First Posted: October 12, 2005
Last Update Posted: May 15, 2008
Last Verified: May 2008

Keywords provided by Glostrup University Hospital, Copenhagen:
Primary hip replacement
Gabapentin
Dexamethasone
Ketamine
Multimodal postoperative analgesia.

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Dexamethasone acetate
Dexamethasone
Ketamine
Gabapentin
BB 1101
gamma-Aminobutyric Acid
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Anesthetics, Dissociative