Regional Anesthesia and Partial Mastectomy

Study Overview
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Brief Summary
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Pectoralis nerves plane block (PECS) first described by Blanco in 2011 has become part of postoperative pain management in breast surgery, thoracic surgery and thoracic trauma. The combination of low complication risk and easiness in mastering of PECS block has made it an interesting alternative to thoracic epidural anesthesia (TEDA) and paravertebral blockade (PVB) for pain treatment after breast surgery. Several studies showed good results when PECS was compared to PVB. PECS blockade however is a procedure requiring some resources in the operating room. An alternative approach is to inject local anesthetics (LA) in the operation field by the surgeon. The hypothesis' tested in this study is primarily: that PECS blockade is superior to LA being injected by surgeon in the operating field measured by end points such as: post-operative pain, post-operative analgesics use, post-operative nausea or vomiting (PONV) and length of stay in the post anesthesia care unit (PACU).

Official Title
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Interpectoral and Pectoserratus Plane Block vs Local Anesthetic Infiltration for Partial Mastectomy - a Prospective Randomized Trial

Conditions
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Breast Neoplasm

Intervention / Treatment
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* Procedure: PECS II
* Procedure: Local anesthetic infiltration
* Procedure: Subcutaneus local anesthetic infiltration
* Drug: Ropivacaine
* Device: bk medical Flex Focus 500 Ultrasound Machine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women scheduled for partial mastectomy (lumpectomy). Exclusion Criteria: Scheduled cryosection Axillary node dissection Re-resection Age under 18 or unable to give an informed concent Chronic pain history Allergy to local anesthetics History of active drug addiction Pregnancy

Ages Eligible for Study
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Minimum Age: 18 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PECS+subcutaneus local anesthetic infiltration<br>Preoperative ultrasound-led PECS II blockade with ropivacaine 3,75mg/ml (2mg/kg). After surgery - wound infiltration by the surgeon with ropivacaine 2mg/ml (1mg/kg). | Procedure: PECS II<br>* Pectoral nerves block (PECS II) is performed with the help of ultrasound. Two injection are performed in two fascial planes. One between pectoralis major muscle and serratus anterior muscle. Second one between pectoralis major and minor muscles.<br>* Other names: Pectoral nerves block;Procedure: Subcutaneus local anesthetic infiltration<br>* Ropivacaine is administered by the surgeon at the end of surgery<br>Drug: Ropivacaine<br>* Local anesthetic ropivacaine is administered in both study arms according to the study protocol<br>* Other names: Local anesthetic;Device: bk medical Flex Focus 500 Ultrasound Machine<br>* Ultrasound with linear probe is performed. Using in-plane technique a correct placement of the injection needle is secured.<br>* Other names: High Frequency Linear 8870 probe;|
| Active Comparator: Local anesthetic infiltration<br>Prior to scrubbing surgeon infiltrates the thought incision area with ropivacaine 3,75/ml (1mg/kg). Perioperatively after removal of the tumor follows the deep infiltration of the wound with ropivacaine 3,75mg/ml (2mg/kg). | Procedure: Local anesthetic infiltration<br>* Ropivacaine is administered by surgeon prior to scrubbing and following the removal of the tumor.<br>Drug: Ropivacaine<br>* Local anesthetic ropivacaine is administered in both study arms according to the study protocol<br>* Other names: Local anesthetic;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maximal pain in PACU measured with 11 point numerical rating scale (NRS) | NRS scale is a validated for assessment of pain. It is a 11 point scale (0-10) used to estimate severity of postoperative pain. On NRS scale the higher value indicates more severe symptoms. | measured at discharge from PACU (on average 4 hours). | 
| Intraoperative fentanyl use | dose of fentanyl used during surgery in milligrams [mg]. | Time is measured from start of the anesthesia until discharge to PACU (on average 3 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative analgesic use | Postoperative analgesic use is related to pain severity and can be a factor leading to increased length of stay in PACU. | measured at 24 hours postoperatively. | 
| Maximal postoperative nausea and vomiting(PONV) in PACU measured with 11 point numerical rating scale (NRS) | PONV NRS similar to pain NRS is an 11 point scale (0-10) used to estimate severity of postoperative nausea. On NRS scale the higher value indicates more severe symptoms. | measured at discharge from PACU (on average 4 hours). | 
| Length of stay in PACU | Is an dependant of multiple factors and an important measurement that can indicate beneficial therapeutic choice. | on average 4 hours. | 
| Maximal postoperative nausea and vomiting(PONV) after discharge from PACU measured with 11 point numerical rating scale (NRS) | PONV NRS similar to pain NRS is an 11 point scale used to estimate severity of postoperative nausea. | 24 hours | 
| Maximal pain after discharge from PACU measured with 11 point numerical rating scale (NRS) | NRS scale is a validated for assessment of pain. | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Segmental Mastectomy,, Analgesia, Regional anesthesia, Breast surgery