Unilateral mastectomy with or without axillary lymph node dissection
Conditions
Interventions
Trade Name: Ropivacain, Fresenius Kabi ® Solution for infusion 2 mg/ml
Product Name: Ropivacain
Product Code: "Not Applicable"
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: ROPIVACAI
Sponsors
Sydvestjysk Sygehus, Esbjerg
Odense Universitetshospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Unilateral mastectomy with or without axillary lymph node dissection after sentinel lymph node biopsy or known lymph node metastases 2. Woman 3. Age > 18 years 4. Capable of giving written informed consent 5. ASA 1-2 (American Society of Anaesthesiologists physical status classification system) 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 64 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 64
Exclusion criteria
Exclusion criteria: 1. Person not capable of using VAS 2. Surgical complications demanding reoperation of the affected breast 3. Any kind of former surgery to the affected breast 4. Pregnancy 5. Patient not capable of giving written informed consent 6. Patient having other kind of breast surgery or axillary lymph node dissection 7. Patient whit new onset of pain or deterioration to chronic pain during the last 24 hours 8. Preoperative receiving treatment with medicine (prescript or non prescript) for new onset of pain or deterioration to chronic pain during the last 14 days. (Patients with well controlled chronic pain without deterioration may participate in the trial) 9. Preoperative receiving treatment with medicine for nausea or vomiting during the last 14 days 10. Patients receiving treatment with MAO-inhibiters or Tricyclic antidepressants during the last 3 months. 11. Patient known to suffer from migraine 12. Other kind of anaesthesia than the one described in the protocol 13. Contraindication towards the investigational medicinal product
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effect on pain relief, after installation of ropivacaine with adrenaline in unilateral mastectomy with or without axillary lymph node dissection, at the end of the operation. The effect is rated via VAS-score (Visual Analogue Scale) an modified VAS-score ;Secondary Objective: Secondary to evaluate the effect on PONV (Postoperative nausea and vomiting), postoperative use of analgesia and antiemetic, length of hospital stay and time till first mobilisation.;Primary end point(s): Visuel analog score;Timepoint(s) of evaluation of this end point: 24 houres after installation of the IMP | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Modified visuel analog score postoperativ Incidence of nausea Incidence of vomiting Use of analgetic Use of antiemetic Time of stay in the postanaesthesia care unit Time till end of hospital stay Time till first mobilisation;Timepoint(s) of evaluation of this end point: 24 houres after installation of the IMP | — |
Countries
Denmark
Contacts
Public ContactAfdelingen for Operation og Anæstes
Sydvestjysk Sygehus, Esbjerg
Outcome results
None listed