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.
Phase 1
- 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.
- Registration Number
- EUCTR2004-005271-42-DK
- Lead Sponsor
- Dept. of Anaestesiology, University hospital in Glostrup
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 0
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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).
- Secondary Outcome Measures
Name Time Method