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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 abdominal hystrectomy.

Effect of paracetamol versus paracetamol combined with pregabalin versus paracetamol combined with pregabalin and dexamethason on pain and opioid requirements in patients scheduled for abdominal hystrectomy.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-005271-42-DK
Enrollment
Unknown
Registered
2008-07-10
Start date
2005-04-13
Completion date
Unknown
Last updated
2016-10-03

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

Conditions

Women scheduled for abdominal hysterectomy needs postoperative pain treatment, i.e. morphine. Morphine has side-effects: nausea, vomiting, sedation and dizziness. These side-effects are of course unpleasant for the patients and sometimes keep them in hospital for a longer time than needed.

Interventions

Product Name: pregabalin Pharmaceutical Form: Capsule* Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use Product Name: Dexamethason Pharmaceutical Form: In

Sponsors

Dept. of Anaestesiology, University hospital in Glostrup
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Women scheduled for abdominal hysterectomy, between the age of 18 and 75. ASA 1-2; and with a BMI: between 18 and 32. 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. has cancer ovarian 3. does not speak Danish 4. has allergy for drugs used in the trial 5. has drug and medicine abuse 6. epilepsy 7. diabetes treated with medicine 8. chronic pain condition 9. daily use of antacids or analgesic 10. Known kidney disease.

Design outcomes

Primary

MeasureTime frame
Main Objective: To improve the postoperative pain treatment for patients with an abdominal hysterectomy, 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 of pregabalin, dexametason and paracetamol can act synergistically in patients who becomes an abdominal hysterectomy.;Primary end point(s): The total amount of morphine needed postoperatively from 0 – 4 h, and 0 – 24 h, administered by patient controlled pain treatment. (PCA).

Countries

Denmark

Outcome results

None listed

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