Overview

Large-scale Prospective Double-blind Randomized Controlled Trial of Pecs II Block for Breast Surgery

Status:
Completed
Trial end date:
2016-03-01
Target enrollment:
0
Participant gender:
Female
Summary
In this prospective trial, Stage 1-3 patients having mastectomies or isolated lumpectomy with axillary node dissection will be randomly assigned to general anesthesia with opioids combined with a Pecs II block or to general anesthesia with opioids combined with a placebo Pecs II block. Participants will be followed postoperatively during their entire hospital stay to determine the effectiveness of Pecs II block and opioids versus placebo Pecs II block and opioids as postoperative pain treatment.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
GZA Ziekenhuizen Campus Sint-Augustinus
Treatments:
Acetaminophen
Analgesics, Opioid
Anesthetics
Atracurium
Levobupivacaine
Pirinitramide
Propofol
Sevoflurane
Sufentanil
Tramadol
Criteria
Inclusion Criteria:

- Primary breast cancer without known extension beyond the breast and axillary nodes
(i.e. believed to be Tumor Stage 1-3, Nodes 0-2)

- Scheduled for unilateral or bilateral mastectomy with or without implant (isolated
"lumpectomy" will not qualify)

- Isolated "lumpectomy" with axillary node dissection (anticipated removal of at least
five nodes)

- Written informed consent, including willingness to be randomized to opioids or
regional analgesia

- Dutch speaking

Exclusion Criteria:

- Previous surgery for breast cancer (except diagnostic biopsies)

- Inflammatory breast cancer

- Scheduled free flap reconstruction

- ASA Physical Status ≥ 4

- Any contraindication to locoregional analgesia (including coagulopathy, abnormal
anatomy)

- Any contraindication to midazolam, propofol, sevoflurane, sufentanyl, tramadol or
piritramide

- Other cancer not believed by the attending surgeon to be in long-term remission

- Systemic disease believed by the attending surgeon to present ≥ 25% two-year mortality

- Obesity defined as BMI ≥ 30 kg/m2

- Chronic use of pain medication (started > 3 months ago)

- Allergic to Chirocaine

- Chronic drug or alcohol abuse

- INR > 1.4

- Thrombocytopenia < 70,000 platelets

- Dementia

- Pregnancy

- Kidney or liver failure