Regional Anesthesia and Partial Mastectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-19

Study Completion Date

2022-05-01

Brief Summary

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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).

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Detailed Description

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Conditions

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Breast Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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PECS+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).

Group Type ACTIVE_COMPARATOR

PECS II

Intervention Type PROCEDURE

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.

Subcutaneus local anesthetic infiltration

Intervention Type PROCEDURE

Ropivacaine is administered by the surgeon at the end of surgery

Ropivacaine

Intervention Type DRUG

Local anesthetic ropivacaine is administered in both study arms according to the study protocol

bk medical Flex Focus 500 Ultrasound Machine

Intervention Type DEVICE

Ultrasound with linear probe is performed. Using in-plane technique a correct placement of the injection needle is secured.

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).

Group Type ACTIVE_COMPARATOR

Local anesthetic infiltration

Intervention Type PROCEDURE

Ropivacaine is administered by surgeon prior to scrubbing and following the removal of the tumor.

Ropivacaine

Intervention Type DRUG

Local anesthetic ropivacaine is administered in both study arms according to the study protocol

Interventions

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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.

Intervention Type PROCEDURE

Local anesthetic infiltration

Ropivacaine is administered by surgeon prior to scrubbing and following the removal of the tumor.

Intervention Type PROCEDURE

Subcutaneus local anesthetic infiltration

Ropivacaine is administered by the surgeon at the end of surgery

Intervention Type PROCEDURE

Ropivacaine

Local anesthetic ropivacaine is administered in both study arms according to the study protocol

Intervention Type DRUG

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.

Intervention Type DEVICE

Other Intervention Names

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Pectoral nerves block Local anesthetic High Frequency Linear 8870 probe

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No