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

Study Overview
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Brief Summary
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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
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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).

Official Title
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Large-scale Prospective Double-blind Randomized Controlled Trial of Pecs II Block for Breast Surgery: Effect on Postoperative Pain and Opioid Consumption

Conditions
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Pain, Postoperative, Postoperative Nausea and Vomiting

Intervention / Treatment
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* Drug: Levobupivacaine
* Drug: NaCl 0.9%
* Drug: Sevoflurane
* Drug: Propofol
* Drug: Sufentanil
* Drug: Atracurium
* Drug: Paracetamol
* Drug: Tramadol
* Drug: Piritramide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pecs II<br>General anesthesia followed by a Pecs II block and opioids if required | Drug: Levobupivacaine<br>* Pecs II Block<br>* Other names: Chirocaine;Drug: Sevoflurane<br>* General Anesthesia<br>Drug: Propofol<br>* General Anesthesia<br>Drug: Sufentanil<br>* General Anesthesia<br>Drug: Atracurium<br>* General Anesthesia<br>Drug: Paracetamol<br>* Pain Relief<br>* Other names: Acetaminophen;Drug: Tramadol<br>* Pain Relief<br>Drug: Piritramide<br>* Pain Relief<br>|
| Placebo Comparator: Placebo<br>General anesthesia followed by a placebo Pecs II block and opioids if required | Drug: NaCl 0.9%<br>* Placebo Pecs II block<br>* Other names: Normal Saline;Drug: Sevoflurane<br>* General Anesthesia<br>Drug: Propofol<br>* General Anesthesia<br>Drug: Sufentanil<br>* General Anesthesia<br>Drug: Atracurium<br>* General Anesthesia<br>Drug: Paracetamol<br>* Pain Relief<br>* Other names: Acetaminophen;Drug: Tramadol<br>* Pain Relief<br>Drug: Piritramide<br>* Pain Relief<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Pain | Within first hour: Each ten minutes by Recovery Nurse. Hour 2 till discharge ( max 72 hours post surgery): hourly by patient through questionnaire.Master data set is administrated by secretarial office of Anesthesia departement | up to 72 hours after completion of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peroperative Opioid Consumption | Anesthetist in charge reports Opioid Consumption. Master data set is administrated by secretarial office of Anesthesia department | Peroperative period (max. 5 hours) | 
| Postoperative Opioid Consumption | Nurse of postoperative recovery room and nurse of ward in charge reports opioid consumption on patient questionnaire. Master data set is administrated by secretarial office of Anesthesia department | up to 72 hours after completion of surgery | 
| Postoperative Nausea and Vomiting | Nurse of postoperative recovery room and nurse of ward in charge reports patients nausea and vomiting as well as the administered medication against postoperative nausea and vomiting on patient questionnaire. Master data set is administrated by secretarial office of Anesthesia department | up to 72 hours after completion of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Analgesics, Opioid, Mastectomy, Segmental Mastectomy, Pecs II