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Completed

NCT Number: NCT00235261

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

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Postoperative Signs and Symptoms

Age range

55 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of anaesthesiology; Hoersholm Sygehus

Hoersholm, Frederiksborg Amt, 2970, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pregabalin

Drug

Dexamethasone

Drug

Primary outcomes

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

Secondary outcomes

  1. Pain score (VAS) at rest and at mobilisation.

  2. Postoperative nausea and vomiting.

  3. Sedation.

  4. Dizziness

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

Sponsors and collaborators

Lead sponsor

Glostrup University Hospital, Copenhagen

Other

Registry information

Official study title

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

Important dates

Study start
2005
Study completion
2007
First posted
Oct 10, 2005
Registry last updated
Aug 17, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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