Regional Anesthesia and Partial Mastectomy

Karlstad Central Hospital

Status: Completed

Conditions: Breast Neoplasm

Treatments: Procedure: Local anesthetic infiltration; Device: bk medical Flex Focus 500 Ultrasound Machine; Drug: Ropivacaine; Procedure: PECS II; Procedure: Subcutaneus local anesthetic infiltration

Study type: Interventional

Funder types: Other

Identifiers

NCT04824599

LIVFOU-930411

Details and patient eligibility

About

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).

Enrollment: 60 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

PECS+subcutaneus local anesthetic infiltration

Active Comparator group

Description:

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).

Treatment:

Drug: Ropivacaine

Procedure: PECS II

Device: bk medical Flex Focus 500 Ultrasound Machine

Procedure: Subcutaneus local anesthetic infiltration

Local anesthetic infiltration

Active Comparator group

Description:

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).

Treatment:

Drug: Ropivacaine

Procedure: Local anesthetic infiltration