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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2007-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pain Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Pregabalin

Intervention Type DRUG

Dexamethasone

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

55 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Ole Mathiesen, MD

Role: STUDY_CHAIR

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

Lars Steen Jacobsen, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Department of anaesthesiology; Hoersholm Sygehus

Hoersholm, Frederiksborg Amt, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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SM3-05

Identifier Type: -

Identifier Source: org_study_id