NCT04824599

Regional Anesthesia and Partial Mastectomy

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Karlstad Central Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Breast Neoplasm

Interventions

Type	Name	Description
PROCEDURE	PECS 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.
PROCEDURE	Local anesthetic infiltration	Ropivacaine is administered by surgeon prior to scrubbing and following the removal of the tumor.
PROCEDURE	Subcutaneus local anesthetic infiltration	Ropivacaine is administered by the surgeon at the end of surgery
DRUG	Ropivacaine	Local anesthetic ropivacaine is administered in both study arms according to the study protocol
DEVICE	bk 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.

Timeline

• Start date: 2021-02-19
• Primary completion: 2022-05-01
• Completion: 2022-05-01
• First posted: 2021-04-01
• Last updated: 2023-09-07

Locations

1 site across 1 country: Sweden