Regional Anesthesia and Partial Mastectomy

Not Applicable

Completed

• Conditions: Breast Neoplasm
• Interventions: Procedure: Local anesthetic infiltration; Procedure: PECS II; Procedure: Subcutaneus local anesthetic infiltration; Drug: Ropivacaine; Device: bk medical Flex Focus 500 Ultrasound Machine

• Registration Number: NCT04824599
• Lead Sponsor: Karlstad Central Hospital

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-19
• Study First Submitted: 2021-03-24
• Study First Submitted QC: 2021-03-27
• Study First Posted: 2021-04-01
• Primary Completion: 2022-05-01
• Study Completion: 2022-05-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-03
• Last Update Posted: 2023-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PECS+subcutaneus local anesthetic infiltration	Subcutaneus local anesthetic infiltration	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).
Local anesthetic infiltration	Local anesthetic infiltration	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).
PECS+subcutaneus local anesthetic infiltration	PECS II	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).
PECS+subcutaneus local anesthetic infiltration	bk medical Flex Focus 500 Ultrasound Machine	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).
Local anesthetic infiltration	Ropivacaine	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).
PECS+subcutaneus local anesthetic infiltration	Ropivacaine	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).

Primary Outcome Measures

Name	Time	Method
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 \[mg\].
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.

Secondary Outcome Measures

Name	Time	Method
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 pain after discharge from PACU measured with 11 point numerical rating scale (NRS)	24 hours	NRS scale is a validated for assessment of pain.
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 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.
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.

Trial Locations

Locations (1)

Central Hospital in Karlstad; 🇸🇪 Karlstad, Värmland, Sweden