Breast cancer Cancer Malignant neoplasm of the breast
Conditions
Interventions
Depending on random allocation to the specific group, on the day of surgery one of the preparations (40 ml) was prepared:
Group A: 100 mg bupivacainum hydrochloricum dissolved in 0.9 % NaCl solution
Sponsors
Medical University of Gdansk (Poland)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Breast cancer patients in disease stage I, II and IIIA without neoadjuvant treatment 2. Patients qualified for radical modified mastectomy 3. Informed consent obtained from the patient 4. Females aged 35 - 90 years
Exclusion criteria
Exclusion criteria: 1. No informed consent obtained from the patient 2. Allergy to bupivacaine or any other local analgesic agent 3. Allergy to any of the drugs used in the analgesia protocol 4. Prior surgically treatment for breast cancer 5. Patient history with treatment of chronic pain 6. Patients with any psychiatric disorders 7. Patients weight below 50 kg
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The quality of multimodal analgesia provided during surgical treatment is assessed in view of fentanyl consumption. In the post-operative period the insensitivity of pain is measured using Visual Analogue Score (VAS) scale ranged 0 - 10, where 0 = no pain and 10 = worst pain. The patient is assessed straight after waking from anaesthesia and at 1, 2, 3, 4, 8, 12, 16, 20, 24, 36 and 48 hours after surgery. In addition, the time of the first morphine dose delivered by patient controlled anaesthesia (PCA), total morphine consumption and the number of attempts to launch PCA during lockout is measured. For assessment of pain insensitivity each patient receive a slide with the VAS scale. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Analysis of numerical values of pain intensity according to VAS scale summed up in the following time ranges: 0 - 4 hours, 4 - 12 hours, 12 - 24 hours, 24 - 48 hours, 0 - 12 hours and 12 - 48 hours 2. Comparison between the group of patients reporting pain (VAS 1 - 10) versus the group of patients with no pain complain (VAS = 0) and a comparison between the group of patients with no or only slight pain sensation (VAS 0 - 2) versus the group of patients with stronger pain (VAS greater than 2) 3. Amounts of morphine consumed in the following time ranges: 0 - 1 hours (from the moment of the end of the surgery till the end of the first post-operative hour), 0 - 4 hours, 0 - 12 hours, 1 - 2 hours and 4 - 12 hours | — |
Countries
Poland
Outcome results
None listed