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Effect of paracetamol versus paracetamol combined with pregabalin versus paracetamol combined with pregabalin and dexamethason on pain and opioid requirements in patients scheduled for a primary total hipreplacement

Effect of paracetamol versus paracetamol combined with pregabalin versus paracetamol combined with pregabalin and dexamethason on pain and opioid requirements in patients scheduled for a primary total hipreplacement

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-002483-28-DK
Enrollment
120
Registered
2005-07-29
Start date
2005-08-03
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient scheduled for a primary total hipreplacement need postoperativ pain treatment. Morphine has side-effects: nausea, vomiting, sedation and dizziness. These sideeffekts are of couse unpleasant for the patients and sometimes keep them in hospital for a longer time than needed.

Interventions

Trade Name: Lyrica Pharmaceutical Form: Capsule* Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use Trade Name: Forticontin Pharmaceutical Form: Pharmaceut

Sponsors

Dept. of Anaestesiology, University hospital in Glostrup
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients scheduled for a total hipreplacement, between the age of 55 and 75, ASA 1-3 and with a BMI between 18 and 35. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients who 1. are unable to cooperate 2. does not speak danish 3. has allergy for the drugs used in the trial 4. has drug and medicin abuse 5. epilepsi 6. medicaly treated diabetes 7. known kidney disease 8. daily use of anagesia - apart from NSAID, COX2 and paracetamol 9. treatment with antidepressives

Design outcomes

Primary

MeasureTime frame
Main Objective: To improve the postoperative pain treatment for patients, who have had done a total hipreplacement, by using a new combination of secondary analgesics, and thereby hopefully minimizing there need for morphine postoperatively.;Secondary Objective: To see if the well-known analgesic effect og pregabalin, dexametason and paracetamol can act synergistically in patients how have had done a total hipreplacement.;Primary end point(s): The total amount of morphine needed postoperatively from 0-4 h, and 0-24h, administered by patient controlled pain treatment.

Countries

Denmark

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026