NCT00236223

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2005

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 12, 2005

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

May 15, 2008

Status Verified

May 1, 2008

Enrollment Period

2.5 years

First QC Date

October 7, 2005

Last Update Submit

May 14, 2008

Conditions

Pain, Postoperative

Keywords

Primary hip replacementGabapentinDexamethasoneKetamineMultimodal postoperative analgesia.

Outcome Measures

Primary Outcomes (1)

  • The total amount of morphine needed postoperatively from 0-4h; and 0-24h, administered by a patient controlled pain treatment.(PCA)

    0-24h

Secondary Outcomes (6)

  • Pain score (VAS)= at rest and at mobilisation.

    0-24h

  • Postoperative Nausea and vomiting.

    0-24h

  • Dizziness

    0-24h

  • Sedation

    0-24h

  • Nightmare and hallucinations.

    0-24h

  • +1 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL
Drug: Gabapentin + dexamethasone + ketamine

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Gabapentin + dexamethasone + ketamineDRUG

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

Also known as: Anti-hyperalgesics, Postoperative pain
1
PlaceboDRUG

Matching placebo

2

Eligibility Criteria

Age55 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Operations og Anæstesiologisk afd. Y, KAS Glostrup

Glostrup Municipality, 2600, Denmark

Location

Anæstesiafdelingen, Herning Centralsygehus

Herning, 7400, Denmark

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

GabapentinDexamethasoneKetamine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AminesOrganic Chemicalsgamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsCyclohexanecarboxylic AcidsAcids, CarbocyclicCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsAmino AcidsAmino Acids, Peptides, and ProteinsPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Ole Mathiesen, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 7, 2005

First Posted

October 12, 2005

Study Start

October 1, 2005

Primary Completion

April 1, 2008

Study Completion

May 1, 2008

Last Updated

May 15, 2008

Record last verified: 2008-05

Locations

DK(2)