NCT00235261

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_4 pain

Timeline
Completed

Started Oct 2005

Typical duration for phase_4 pain

Geographic Reach
1 country

1 active site

Status
completed

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
5 days until next milestone

First Submitted

Initial submission to the registry

October 6, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 10, 2005

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

August 17, 2007

Status Verified

August 1, 2007

First QC Date

October 6, 2005

Last Update Submit

August 16, 2007

Conditions

PainPostoperative

Keywords

Total hip replacementPregablinDexamethasoneMultimodal postoperative analgesia.

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (5)

  • 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

Interventions

PregabalinDRUG
DexamethasoneDRUG

Eligibility Criteria

Age55 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of anaesthesiology; Hoersholm Sygehus

Hoersholm, Frederiksborg Amt, 2970, Denmark

Location

MeSH Terms

Conditions

Pain

Interventions

PregabalinDexamethasone

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino 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

    STUDY CHAIR

  • Lars Steen Jacobsen, MD

    Departmentof Anaesthesiology; Hørsholm Sygehus; Usserød Kongevej 102; 2970 Hørsholm; Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 6, 2005

First Posted

October 10, 2005

Study Start

October 1, 2005

Study Completion

June 1, 2007

Last Updated

August 17, 2007

Record last verified: 2007-08

Locations

DK(1)