Preemptive analgesia with bupivacaine in mastectomy

Completed

Conditions: Breast cancer
Cancer
Malignant neoplasm of the breast

Registration Number: ISRCTN33898123

Lead Sponsor: Medical University of Gdansk (Poland)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 100

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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<br>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)<br>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