Regional Anesthesia and Partial Mastectomy

NCT04824599 | Completed

• 1 other identifier: LIVFOU-930411
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Breast Neoplasm

Keywords

Segmental Mastectomy,; Analgesia; Regional anesthesia; Breast surgery

Outcome Measures

Primary Outcomes (2)

• maximal pain in PACU measured with 11 point numerical rating scale (NRS)

  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

  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 Outcomes (5)

• Postoperative analgesic use

  measured at 24 hours postoperatively.

• 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).

• Length of stay in PACU

  on average 4 hours.

• Maximal postoperative nausea and vomiting(PONV) after discharge from PACU measured with 11 point numerical rating scale (NRS)

  24 hours

• Maximal pain after discharge from PACU measured with 11 point numerical rating scale (NRS)

  24 hours

Study Arms (2)

PECS+subcutaneus local anesthetic infiltration

ACTIVE COMPARATOR

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; Procedure: Subcutaneus local anesthetic infiltration; Drug: Ropivacaine; Device: bk medical Flex Focus 500 Ultrasound Machine

Local anesthetic infiltration

ACTIVE COMPARATOR

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).

Procedure: Local anesthetic infiltration; Drug: Ropivacaine

Interventions

PECS II 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.

Also known as: Pectoral nerves block

PECS+subcutaneus local anesthetic infiltration

Local anesthetic infiltration PROCEDURE

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

Local anesthetic infiltration

Subcutaneus local anesthetic infiltration PROCEDURE

Ropivacaine is administered by the surgeon at the end of surgery

PECS+subcutaneus local anesthetic infiltration

Ropivacaine DRUG

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

Also known as: Local anesthetic

Local anesthetic infiltration; PECS+subcutaneus local anesthetic infiltration

bk medical Flex Focus 500 Ultrasound Machine DEVICE

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

Also known as: High Frequency Linear 8870 probe

PECS+subcutaneus local anesthetic infiltration

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women scheduled for partial mastectomy (lumpectomy).

You may not qualify if:

• 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

Sponsors & Collaborators

• Karlstad Central Hospital: lead

Study Sites (1)

Central Hospital in Karlstad

Karlstad, Värmland County, 652 30, Sweden

Location

Related Publications (7)

• Jacobs A, Lemoine A, Joshi GP, Van de Velde M, Bonnet F; PROSPECT Working Group collaborators#. PROSPECT guideline for oncological breast surgery: a systematic review and procedure-specific postoperative pain management recommendations. Anaesthesia. 2020 May;75(5):664-673. doi: 10.1111/anae.14964. Epub 2020 Jan 26.

  PMID: 31984479 BACKGROUND

• Blanco R. The 'pecs block': a novel technique for providing analgesia after breast surgery. Anaesthesia. 2011 Sep;66(9):847-8. doi: 10.1111/j.1365-2044.2011.06838.x. No abstract available.

  PMID: 21831090 BACKGROUND

• Apfel CC, Roewer N, Korttila K. How to study postoperative nausea and vomiting. Acta Anaesthesiol Scand. 2002 Sep;46(8):921-8. doi: 10.1034/j.1399-6576.2002.460801.x.

  PMID: 12190791 BACKGROUND

• Woodworth GE, Ivie RMJ, Nelson SM, Walker CM, Maniker RB. Perioperative Breast Analgesia: A Qualitative Review of Anatomy and Regional Techniques. Reg Anesth Pain Med. 2017 Sep/Oct;42(5):609-631. doi: 10.1097/AAP.0000000000000641.

  PMID: 28820803 BACKGROUND

• Habib AS, Kertai MD, Cooter M, Greenup RA, Hwang S. Risk factors for severe acute pain and persistent pain after surgery for breast cancer: a prospective observational study. Reg Anesth Pain Med. 2019 Feb;44(2):192-199. doi: 10.1136/rapm-2018-000040. Epub 2019 Jan 5.

  PMID: 30700614 BACKGROUND

• Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Validity of four pain intensity rating scales. Pain. 2011 Oct;152(10):2399-2404. doi: 10.1016/j.pain.2011.07.005.

  PMID: 21856077 BACKGROUND

• Eisler P, Zimmermann S, Henningsson R. Interpectoral and Pectoserratus Plane Block vs. Local Anesthetic Infiltration for Partial Mastectomy: A Prospective Randomized Trial. Pain Res Manag. 2024 Mar 20;2024:9989997. doi: 10.1155/2024/9989997. eCollection 2024.

  PMID: 38550709 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Agnosia

Interventions

Ropivacaine; Anesthetics, Local

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Ragnar Henningsson, PhD

  Örebro University, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant in Anesthesiology and Intensive care

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: April 1, 2021
• Study Start: February 19, 2021
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: September 7, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)