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Completed

NCT Number: NCT04824599

Regional Anesthesia and Partial Mastectomy

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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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Central Hospital in Karlstad

Karlstad, Värmland County, 652 30, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Pectoral nerves block

local anesthetic infiltration

Procedure

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

Subcutaneus local anesthetic infiltration

Procedure

Ropivacaine is administered by the surgeon at the end of surgery

Ropivacaine

Drug

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

Other names: Local anesthetic

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.

Other names: High Frequency Linear 8870 probe

Primary outcomes

  1. 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.

  2. 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].

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Karlstad Central Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 1, 2021
Registry last updated
Sep 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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