Regional Anesthesia and Partial Mastectomy

September 3, 2023 updated by: Patryk Eisler, Karlstad Central Hospital

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Värmland
      • Karlstad, Värmland, Sweden, 652 30
        • Central Hospital in Karlstad

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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).
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.
Other Names:
  • Pectoral nerves block
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
Other Names:
  • Local anesthetic
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.
Other Names:
  • High Frequency Linear 8870 probe
Active Comparator: 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).
Drug: Ropivacaine
Local anesthetic ropivacaine is administered in both study arms according to the study protocol
Other Names:
  • Local anesthetic
Procedure: Local anesthetic infiltration
Ropivacaine is administered by surgeon prior to scrubbing and following the removal of the tumor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
maximal pain in PACU measured with 11 point numerical rating scale (NRS)
Time Frame: 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.
measured at discharge from PACU (on average 4 hours).
Intraoperative fentanyl use
Time Frame: 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].
Time is measured from start of the anesthesia until discharge to PACU (on average 3 hours)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximal postoperative nausea and vomiting(PONV) in PACU measured with 11 point numerical rating scale (NRS)
Time Frame: 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.
measured at discharge from PACU (on average 4 hours).
Postoperative analgesic use
Time Frame: 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.
measured at 24 hours postoperatively.
Length of stay in PACU
Time Frame: on average 4 hours.
Is an dependant of multiple factors and an important measurement that can indicate beneficial therapeutic choice.
on average 4 hours.
Maximal pain after discharge from PACU measured with 11 point numerical rating scale (NRS)
Time Frame: 24 hours
NRS scale is a validated for assessment of pain.
24 hours
Maximal postoperative nausea and vomiting(PONV) after discharge from PACU measured with 11 point numerical rating scale (NRS)
Time Frame: 24 hours
PONV NRS similar to pain NRS is an 11 point scale used to estimate severity of postoperative nausea.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karlstad Central Hospital

Investigators

  • Principal Investigator: Ragnar Henningsson, PhD, Örebro University, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 19, 2021

Primary Completion (Actual)

May 1, 2022

Study Completion (Actual)

May 1, 2022

Study Registration Dates

First Submitted

March 24, 2021

First Submitted That Met QC Criteria

March 27, 2021

First Posted (Actual)

April 1, 2021

Study Record Updates

Last Update Posted (Actual)

September 7, 2023

Last Update Submitted That Met QC Criteria

September 3, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LIVFOU-930411

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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