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

NCT ID: NCT00236223

Last Updated: 2008-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2008-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pain, Postoperative

Keywords

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Primary hip replacement Gabapentin Dexamethasone Ketamine Multimodal postoperative analgesia.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

Gabapentin + dexamethasone + ketamine

Intervention Type DRUG

Comparing analgesic effect of gabapentin 1200 mg + dexamethasone 8 mg + ketamine 0.15 mg/kg

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo

Interventions

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Gabapentin + dexamethasone + ketamine

Comparing analgesic effect of gabapentin 1200 mg + dexamethasone 8 mg + ketamine 0.15 mg/kg

Intervention Type DRUG

Placebo

Matching placebo

Intervention Type DRUG

Other Intervention Names

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Anti-hyperalgesics Postoperative pain

Eligibility Criteria

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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.
Minimum Eligible Age

55 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Glostrup University Hospital, Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Dept of anaesthesiology

Principal Investigators

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Ole Mathiesen, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anaesthesiology, Copenhagen University Hospital in Glostrup, 2600 Glostrup, Denmark

Locations

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Operations og Anæstesiologisk afd. Y, KAS Glostrup

Glostrup Municipality, , Denmark

Site Status

Anæstesiafdelingen, Herning Centralsygehus

Herning, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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SM2-05

Identifier Type: -

Identifier Source: org_study_id