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

Pain Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00235261
• Other study ID #: SM3-05
• Status: Completed
• Phase: Phase 4
• First received: October 6, 2005
• Last updated: August 16, 2007
• Start date: October 2005
• Est. completion date: June 2007

Study information

• Verified date: August 2007
• Source: Glostrup University Hospital, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Medicines AgencyDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain
• Postoperative

Intervention

Drug:
• Pregabalin

• Dexamethasone

Locations

Country	Name	City	State
Denmark	Department of anaesthesiology; Hoersholm Sygehus	Hoersholm	Frederiksborg Amt

Sponsors (1)

Lead Sponsor	Collaborator
Glostrup University Hospital, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The total amount of morphine needed postoperatively from 0-4 h, and 0-24 h, administered by a patient controlled pain treatment. (PCA)
Secondary	Pain score (VAS) at rest and at mobilisation.
Secondary	Postoperative nausea and vomiting.
Secondary	Sedation.
Secondary	Dizziness
Secondary	All measurements are taken at 2,4 and 24 h postoperatively