Large-scale Prospective Double-blind Randomized Controlled Trial of Pecs II Block for Breast Surgery
Condition: Pain, Postoperative; Postoperative Nausea and Vomiting
MeSH terms: Vomiting; Pain, Postoperative; Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      Each year, 9400 new cases of breast cancer are diagnosed in Belgium. It makes breast cancer
      the most common cancer in women, good for more than one third of all cancer cases in women.

      Surgical excision of the tumour is a necessary and effective step to cure from the disease.
      Recent studies have demonstrated the positive effects of regional anesthesia on peroperative
      and postoperative pain. Paravertebral blocks have become popular as an alternative to the
      analgesia provided by the 'gold standard' of thoracic epidural analgesia. However, both
      regional techniques have complications and slow learning curves that make them unsuitable for
      the large proportion of breast surgery patients who are treated on a day-stay basis.
      Recently, Rafael Blanco introduced the Pecs and Pecs II blocks, a practical alternative to
      both paravertebral and epidural blockade in the management of pain after breast surgery.

      The investigators introduced the Pecs II block in their clinical practice. This study
      compares general anesthesia with a Pecs II block to general anesthesia with a placebo Pecs II
      block for breast surgery. The objective is to evaluate analgesic effectiveness and changes in
      opioid consumption when applying a Pecs II block versus a placebo Pecs II block.

      Stage 1-3 patients having mastectomies or tumourectomies with axillary clearance will be
      randomly assigned to general anesthesia with a Pecs II block or to general anesthesia with a
      placebo Pecs II block. Enrolling 140 patients over an anticipated time frame of 2 years will
      provide an 90% power and a p-value of 0.05 for perioperative and postoperative opioid
      consumption as well as pain scores (NRS). Confirming the hypothesis will indicate that a
      minor modification to the anesthetic procedure will reduce the opioid consumption (including
      it's unwanted side effects) during and after surgery while maintaining or reducing patients'
      indicated pain scores (NRS).
    

Intervention name(s): Levobupivacaine; NaCl 0.9%; Sevoflurane; Propofol; Sufentanil; Atracurium; Paracetamol; Tramadol; Piritramide
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Pecs II Block; Placebo Pecs II block; General Anesthesia; General Anesthesia; General Anesthesia; General Anesthesia; Pain Relief; Pain Relief; Pain Relief
Other intervention name(s): Chirocaine; Normal Saline; Acetaminophen
Intervention MeSH terms: Acetaminophen; Sufentanil; Tramadol; Pirinitramide; Propofol; Sevoflurane; Levobupivacaine; Atracurium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Analgesics; Opioid; Mastectomy; Segmental Mastectomy; Pecs II