Effect of Paracetamol, Pregabalin and Dexamethasone on Pain and Opioid Requirements in Patients After Hip Operations

August 16, 2007 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 a Primary Total Hip Replacement

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

We investigate the effect of paracetamol versus paracetamol + pregabalin versus paracetamol + pregabalin + dexamethasone on pain and morphine usage in the first 24 hours postoperatively in patients getting a new hip alloplastic.

Study Type

Interventional

Enrollment (Anticipated)

120

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

  • Denmark
    • Frederiksborg Amt
      • Hoersholm, Frederiksborg Amt, Denmark, 2970
        • Department of anaesthesiology; Hoersholm Sygehus

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

55 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Dizziness
Pain score (VAS) at rest and at mobilisation.
Postoperative nausea and vomiting.
Sedation.
All measurements are taken at 2,4 and 24 h postoperatively

Collaborators and Investigators

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

Sponsor

Glostrup University Hospital, Copenhagen

Investigators

  • Study Chair: Ole Mathiesen, MD, Department of Anaesthesiology, Copenhagen University Hospital in Glostrup, 2600 Glostrup, Denmark
  • Principal Investigator: Lars Steen Jacobsen, MD, Departmentof Anaesthesiology; Hørsholm Sygehus; Usserød Kongevej 102; 2970 Hørsholm; 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

October 1, 2005

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

October 6, 2005

First Submitted That Met QC Criteria

October 7, 2005

First Posted (Estimate)

October 10, 2005

Study Record Updates

Last Update Posted (Estimate)

August 17, 2007

Last Update Submitted That Met QC Criteria

August 16, 2007

Last Verified

August 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SM3-05

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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