Postoperative pain in patients undergoing primary, elective, open, abdominal hysterectomy. MedDRA version: 9.1 Level: LLT Classification code 10054711 Term: Postoperative pain
Conditions
Sponsors
Nycomed Danmark ApS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent obtained according to local regulations before any trial-related activities. A trial-related activity is any procedure that would not have been performed during the routine management of the patient 2. Females 18 years of age and above 3. A planned elective, open abdominal hysterectomy for a non-malignant indication that requires a Pfannenstiel incision. Surgery could be either supravaginal hysterectomy or a total abdominal hysterectomy (with or without salpingo-oophorectomy) 4. Patients suitable for general anaesthesia 5. Body Mass Index (BMI) no more than 35 kg/m2 6. A requirement to refrain from strenuous activities throughout the trial period and to avoid modifications to prescribed exercise levels throughout the course of the trial 7. Ability to read, understand, communicate and voluntarily sign the approved informed consent form prior to the performance of any trial specific procedures 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: 1. Participation in another clinical trial with an investigational drug or device within 30 days before inclusion in this trial 2. Previous enrolment into this trial 3. Known serious / important reactions in previous anaesthesia procedures with local anaesthetics 4. Known clinically significant hepatic, gastrointestinal, renal, haematological, urologic, neurological, respiratory, endocrine or cardiovascular system abnormalities 5. Known serious uncontrolled illness: cancer, psychiatric or metabolic disturbances. History of cured localised malignancies is allowed (i.e. basal or squamous cell skin carcinoma, breast carcinoma or cervical carcinoma) 6. Abnormal ECG (interpretation of ECG must be done by physician). Abnormalities such as sinus tachycardia, right bundle branch block, ectopic atrial rhythm or premature atriel contractions are not necessarily reason for exclusion (interpretation by physician) 7. Prolonged QT syndrome (QT higher than 470 msec) or family history of long QT syndrome (interpretation of ECG must be done by physician) 8. Current or regular use of analgesic medication for other indication(s) 9. Current or regular use of antidepressants, monoamine oxidase inhibitors, or medication known to be associated with QT prolongation (see appendix 1) 10. Conditions contraindicated for use of opioids, including paralytic ileus, acute or severe bronchial asthma or hypercarbia 11. Current or regular use of anticonvulsants or antiepileptics 12. Connective tissue disorders (systemic lupus erythematosus, scleroderma, mixed connective tissue disease 13. Known or suspected alcohol abuse or illicit drug use within the 6 months prior to trial enrolment 14. Known sensitivity to bupivacaine (or similar local anaesthetics), benzyl alcohol or other trial drugs (paracetamol, morphine) or their constituents 15. Unwillingness or inability to comply with the trial visit 16. Situated in an institution due to regulatory order or judicial direction.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective is to identify the optimal dose of instilled SABER-Bupivacaine for postoperative pain control in abdominal hysterectomy for a non-malignant indication on the basis of efficacy, safety and pharmacokinetics evaluations.;Secondary Objective: No secondary objective;Primary end point(s): Two primary endpoints will be used: •Pain intensity (PI) on movement area under the curve (AUC) over the time period 1 to 72 hours after surgery. For the purpose of interpretation, the AUC will be normalised by dividing with the time interval over which it is computed •Total use of opioid rescue analgesia 0 to 72 hours after surgery | — |
Countries
France, Germany, Hungary, Latvia, Sweden, United Kingdom
Outcome results
None listed