NCT00209495

Brief Summary

Women scheduled for abdominal hysterectomy needs postoperative pain treatment, i.e. morphine. Unfortunately morphine has side-effect: 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2005

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

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

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

February 29, 2008

Status Verified

February 1, 2008

Enrollment Period

2.4 years

First QC Date

September 13, 2005

Last Update Submit

February 28, 2008

Conditions

Pain, Postoperative

Keywords

Abdominal hysterectomyPregabalinDexamethasoneMultimodal postoperative analgesia

Outcome Measures

Primary Outcomes (1)

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

    0 - 24h

Secondary Outcomes (5)

  • Pain Score (VAS) at rest and at mobilisation.

    0 - 24h

  • Postoperative nausea and vomiting.

    0 - 24h

  • Sedation.

    0 - 24h

  • Dizziness.

    0 - 24h

  • All measurements are taken at 2, 4 and 24 h postoperatively.

    0 - 24h

Study Arms (3)

A

PLACEBO COMPARATOR
Drug: Pregabalin; Dexamethasone

B

EXPERIMENTAL

Pregabalin

Drug: Pregabalin; Dexamethasone

C

EXPERIMENTAL

Pregabalin + dexamethasone

Drug: Pregabalin; Dexamethasone

Interventions

Pregabalin; DexamethasoneDRUG

Comparing combinations of paracetamol + pregabalin 300 mg + dexamethasone 8 mg

ABC

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women scheduled for abdominal hysterectomy, between the age of 18 and 75, ASA 1-2
  • BMI between 18-32.

You may not qualify if:

  • Patients who:
  • Are unable to cooperate
  • Has cancer ovarian
  • Does not speak Danish
  • Has allergy for drugs used in the trial
  • Has drug and medicine abuse
  • Epilepsy
  • Diabetes treated with medicine
  • Chronic pain condition
  • Daily use of antacids or analgesic
  • Known kidney disease
  • Use of antidepressive

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Operations og Anæstesiologisk afd. Y, KAS Glostrup

Glostrup Municipality, Copenhagen, 2600, Denmark

Location

Herning Centralsygehus

Herning, 7400, Denmark

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

PregabalinDexamethasone

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns 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

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

June 1, 2005

Primary Completion

November 1, 2007

Study Completion

February 1, 2008

Last Updated

February 29, 2008

Record last verified: 2008-02

Locations

DK(2)