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

Phase 4

Completed

• Conditions: Pain; Postoperative

• Registration Number: NCT00235261
• Lead Sponsor: Glostrup University Hospital, Copenhagen

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.

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 Timeline

• Study Start: 2005-10
• Study First Submitted: 2005-10-06
• Study First Submitted QC: 2005-10-07
• Study First Posted: 2005-10-10
• Study Completion: 2007-06
• Status Verified: 2007-08
• Last Update Submitted: 2007-08-16
• Last Update Posted: 2007-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Department of anaesthesiology; Hoersholm Sygehus; 🇩🇰 Hoersholm, Frederiksborg Amt, Denmark