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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:
Information provided by:
Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier:
NCT00236223
First received: October 7, 2005
Last updated: May 14, 2008
Last verified: May 2008
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain score (VAS)= at rest and at mobilisation. [ Time Frame: 0-24h ] [ Designated as safety issue: No ]
  • Postoperative Nausea and vomiting. [ Time Frame: 0-24h ] [ Designated as safety issue: No ]
  • Dizziness [ Time Frame: 0-24h ] [ Designated as safety issue: No ]
  • Sedation [ Time Frame: 0-24h ] [ Designated as safety issue: No ]
  • Nightmare and hallucinations. [ Time Frame: 0-24h ] [ Designated as safety issue: No ]
  • All measurements are taken at 2,4 and 24 h postoperatively. [ Time Frame: 0-24h ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   55 Years to 85 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Ole Mathiesen, Dept of anaesthesiology
ClinicalTrials.gov Identifier: NCT00236223     History of Changes
Other Study ID Numbers: SM2-05
Study First Received: October 7, 2005
Last Updated: May 14, 2008
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:
Primary hip replacement
Gabapentin
Dexamethasone
Ketamine
Multimodal postoperative analgesia.

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Gabapentin
Ketamine
Analgesics
Anesthetics
Anesthetics, Dissociative
Anesthetics, General
Anesthetics, Intravenous
Anti-Anxiety Agents
Anti-Dyskinesia Agents
Anti-Inflammatory Agents
Anticonvulsants
Antiemetics
Antimanic Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Antiparkinson Agents
Autonomic Agents
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants

ClinicalTrials.gov processed this record on November 24, 2014