Clinical trial NCT02544282: Large-scale Prospective Double-blind Randomized Controlled Trial of Pecs II Block for Breast Surgery
Official title: Large-scale Prospective Double-blind Randomized Controlled Trial of Pecs II Block for Breast Surgery: Effect on Postoperative Pain and Opioid Consumption
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Postoperative Nausea and Vomiting
Keywords: Analgesics
Opioid
Mastectomy
Segmental Mastectomy
Pecs II
Lead sponsor: GZA Ziekenhuizen Campus Sint-Augustinus
Sponsor class: OTHER
First posted: 2015-09-09
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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).

Eligibility 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

Primary outcomes:
measure: Postoperative Pain
timeFrame: up to 72 hours after completion of surgery
Secondary outcomes:
measure: Peroperative Opioid Consumption
timeFrame: Peroperative period (max. 5 hours)
measure: Postoperative Opioid Consumption
timeFrame: up to 72 hours after completion of surgery
measure: Postoperative Nausea and Vomiting
timeFrame: up to 72 hours after completion of surgery
Other outcomes:
Locations:
city: Wilrijk
country: Belgium
facility: GZA Sint Augustinus
state: Antwerpen
Study officials:
affiliation: GZA Ziekenhuizen Campus Sint-Augustinus
name: Barbara JB Versyck, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Blanco R, Fajardo M, Parras Maldonado T. Ultrasound description of Pecs II (modified Pecs I): a novel approach to breast surgery. Rev Esp Anestesiol Reanim. 2012 Nov;59(9):470-5. doi: 10.1016/j.redar.2012.07.003. Epub 2012 Aug 29.