Background
Postoperative pain after breast cancer surgery is usually short and moderate, but as a risk factor for chronic pain, it should be a critical target. Moreover, it is crucial for these patients during this early stage of their treatment not to step into a vicious circle of deconditioning, fatigue and chronic pain. Therefore, fast rehabilitation methods should be promoted.
Partial
... [Show full abstract] mastectomy with sentinel lymph node dissection can be performed under general anesthesia or paravertebral block, either alone or associated with sedation or general anesthesia. Paravertebral blockade provides an efficient analgesia, allowing a reduction of morphine consumption and postoperative nausea and vomiting, has been showed to prevent chronic pain and may reduce the risk of recurrence or metastasis. It is a long-known regional anesthetic technique, but has been more commonly used recently for thoracic surgery, including breast surgery, since generalization of ultra-sound guidance brought security and reliability to the procedure. However, a sedation is often necessary to reduce anxiety, which can be high in this type of surgery.
Hypnosis is an excellent alternative to sedation and general anesthesia. It improves patient comfort and reduces anxiety, without impending surgical quality. Therefore hypnosis and paravertebral block are an interesting association for the perioperative management of breast cancer patients.
We propose to study the efficacy of associated paravertebral block and hypnosis, compared to general anesthesia, on acute pain. The results of this pilot study will ground a future randomized trial on the subject.
Trial design
This is a pilot, non-interventional, observational, prospective study.
Patients will receive either remifentanil for general anesthesia, or a paravertebral block with hypnosis. A hypnotic trance will be maintained until the end of surgery, and a small dose of remifentanil (0,025 μg.Kg-1.min-1) and/or a supplementary local anesthesia can be administered in case of discomfort during surgery. Should this discomfort persist, general anesthesia can be induced.
Postoperative analgesia includes level I and II analgesics, with morphine in case of severe pain.
Eligibility criteria
Patients with primitive breast cancer scheduled for elective partial mastectomy with sentinel lymph node dissection.
Specific aims
The objective is to demonstrate the superiority of paravertebral block with hypnosis, compared to general anesthesia with opioid analgesia, in the postoperative acute pain management.
Primary endpoint will be pain intensity on a numeric rating scale 24 hours after surgery. Secondary endpoints include pain intensity 1, 6 hours and 3 months after surgery, morphine consumption, nausea and vomiting, patient comfort and satisfaction on a 0 to 10 scale. Additionnally, an analysis of surgical oncologic criteria is aimed to prove that there is no significant difference in the margin status between these two groups.
Statistical methods
For quantitative variables, T Student test or Mann Whitney test will be used as appropriate. Fisher's exact test will be used for categorical data.
Accrual
Accrual as for June 11, 2013 is 7 patients. Target accrual is 40 patients.
Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr OT2-2-02.
