Regional Anesthesia and Partial Mastectomy
NCT04824599 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2023-09-07
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
- 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.
Sponsors & Collaborators
-
Karlstad Central Hospital
lead OTHER
Principal Investigators
-
Ragnar Henningsson, PhD · Örebro University, Sweden
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-02-19
- Primary Completion
- 2022-05-01
- Completion
- 2022-05-01
Countries
- Sweden
Study Locations
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