Effect of Paracetamol,Pregabalin and Dexamethasone on Pain and Opioid Requirements in Postoperative Patients

February 28, 2008 updated by: Glostrup University Hospital, Copenhagen

Effect of Paracetamol Versus Paracetamol Combined With Pregabalin Versus Paracetamol Combined With Pregabalin and Dexamethasone on Pain and Opioid Requirements in Patients Scheduled for Abdominal Hysterectomy.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Combinations of paracetamol versus paracetamol + pregabalin versus paracetamol + pregabalin + dexamethasone is investigated. Primary outcome is 24 hours morphine usage.

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Herning, Denmark, 7400
        • Herning Centralsygehus
    • Copenhagen
      • Glostrup, Copenhagen, Denmark, 2600
        • Operations og Anæstesiologisk afd. Y, KAS Glostrup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: A
Comparing combinations of paracetamol + pregabalin 300 mg + dexamethasone 8 mg
Experimental: B
Pregabalin
Comparing combinations of paracetamol + pregabalin 300 mg + dexamethasone 8 mg
Experimental: C
Pregabalin + dexamethasone
Comparing combinations of paracetamol + pregabalin 300 mg + dexamethasone 8 mg

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain Score (VAS) at rest and at mobilisation.
Time Frame: 0 - 24h
0 - 24h
Postoperative nausea and vomiting.
Time Frame: 0 - 24h
0 - 24h
Sedation.
Time Frame: 0 - 24h
0 - 24h
Dizziness.
Time Frame: 0 - 24h
0 - 24h
All measurements are taken at 2, 4 and 24 h postoperatively.
Time Frame: 0 - 24h
0 - 24h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ole Mathiesen, MD, Department of Anaesthesiology, Copenhagen University Hospital in Glostrup, 2600 Glostrup, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

February 29, 2008

Last Update Submitted That Met QC Criteria

February 28, 2008

Last Verified

February 1, 2008

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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