Breast Neoplasm
Conditions
Keywords
Segmental Mastectomy,, Analgesia, Regional anesthesia, Breast surgery
Brief summary
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).
Interventions
PROCEDUREPECS II
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.
PROCEDURELocal anesthetic infiltration
Ropivacaine is administered by surgeon prior to scrubbing and following the removal of the tumor.
PROCEDURESubcutaneus local anesthetic infiltration
Ropivacaine is administered by the surgeon at the end of surgery
DRUGRopivacaine
Local anesthetic ropivacaine is administered in both study arms according to the study protocol
DEVICEbk medical Flex Focus 500 Ultrasound Machine
Ultrasound with linear probe is performed. Using in-plane technique a correct placement of the injection needle is secured.
Sponsors
Karlstad Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| maximal pain in PACU measured with 11 point numerical rating scale (NRS) | measured at discharge from PACU (on average 4 hours). | 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. |
| Intraoperative fentanyl use | Time is measured from start of the anesthesia until discharge to PACU (on average 3 hours) | dose of fentanyl used during surgery in milligrams \[mg\]. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of stay in PACU | on average 4 hours. | Is an dependant of multiple factors and an important measurement that can indicate beneficial therapeutic choice. |
| Postoperative analgesic use | measured at 24 hours postoperatively. | Postoperative analgesic use is related to pain severity and can be a factor leading to increased length of stay in PACU. |
| Maximal pain after discharge from PACU measured with 11 point numerical rating scale (NRS) | 24 hours | NRS scale is a validated for assessment of pain. |
| Maximal postoperative nausea and vomiting(PONV) after discharge from PACU measured with 11 point numerical rating scale (NRS) | 24 hours | PONV NRS similar to pain NRS is an 11 point scale used to estimate severity of postoperative nausea. |
| Maximal postoperative nausea and vomiting(PONV) in PACU measured with 11 point numerical rating scale (NRS) | measured at discharge from PACU (on average 4 hours). | 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. |
Countries
Sweden
Outcome results
None listed