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AzTrials

Breast NeoplasmNCT04824599

Regional Anesthesia and Partial Mastectomy

A study testing PECS II, Local anesthetic infiltration and Subcutaneus local anesthetic infiltration in people with Breast Neoplasm, run by Karlstad Central Hospital at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Neoplasm
What is being tested?
PECS II, Local anesthetic infiltration and Subcutaneus local anesthetic infiltration
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteSweden
Study dates
19 Feb 2021to 1 May 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Women scheduled for partial mastectomy (lumpectomy).

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Central Hospital in Karlstad

    Karlstad, Värmland County, 652 30

Other trials in Sweden

About this study

Official title: 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).

Conditions
Breast Neoplasm
Being tested
PECS II, Local anesthetic infiltration, Subcutaneus local anesthetic infiltration, Ropivacaine, bk medical Flex Focus 500 Ultrasound Machine
Keywords
Segmental Mastectomy,, Analgesia, Regional anesthesia, Breast surgery
Medical subject headings
Breast Neoplasms, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PECS IIProcedure or surgery

    Also called Pectoral nerves block

    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.

  • Local anesthetic infiltrationProcedure or surgery

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

  • Subcutaneus local anesthetic infiltrationProcedure or surgery

    Ropivacaine is administered by the surgeon at the end of surgery

  • RopivacaineDrug

    Also called Local anesthetic

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

  • bk medical Flex Focus 500 Ultrasound MachineDevice

    Also called High Frequency Linear 8870 probe

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

Study groups in NCT04824599
Study groupRoleWhat they receive
PECS+subcutaneus local anesthetic infiltrationActive comparatorPreoperative 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).
Receives: Procedure: PECS II; Procedure: Subcutaneus local anesthetic infiltration; Drug: Ropivacaine; Device: bk medical Flex Focus 500 Ultrasound Machine
Local anesthetic infiltrationActive comparatorPrior 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).
Receives: Procedure: Local anesthetic infiltration; Drug: Ropivacaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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: measured at discharge from PACU (on average 4 hours).

  2. Intraoperative fentanyl use

    dose of fentanyl used during surgery in milligrams [mg].

    Measured: Time is measured from start of the anesthesia until discharge to PACU (on average 3 hours)

Secondary outcomes (5)

  1. Postoperative analgesic use

    Postoperative analgesic use is related to pain severity and can be a factor leading to increased length of stay in PACU.

    Measured: measured at 24 hours postoperatively.

  2. Maximal postoperative nausea and vomiting(PONV) in PACU measured with 11 point numerical rating scale (NRS)

    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: measured at discharge from PACU (on average 4 hours).

  3. Length of stay in PACU

    Is an dependant of multiple factors and an important measurement that can indicate beneficial therapeutic choice.

    Measured: on average 4 hours.

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

    PONV NRS similar to pain NRS is an 11 point scale used to estimate severity of postoperative nausea.

    Measured: 24 hours

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

    NRS scale is a validated for assessment of pain.

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2021
  2. Study start19 Feb 2021
  3. Primary completion1 May 2022
  4. Study completion1 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04824599
Sponsor's protocol ID
LIVFOU-930411
Status last verified
Sep 2023
First submitted
24 Mar 2021
Last updated
7 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31984479

  • 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.

    PubMed 21831090

  • 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.

    PubMed 12190791

  • 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.

    PubMed 28820803

  • 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.

    PubMed 30700614

  • 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.

    PubMed 21856077

  • 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.

    PubMed 38550709

Questions about this trial

What is this clinical trial studying?

A study testing PECS II, Local anesthetic infiltration and Subcutaneus local anesthetic infiltration in people with Breast Neoplasm, run by Karlstad Central Hospital at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

maximal pain in PACU measured with 11 point numerical rating scale (NRS) (time frame: measured at discharge from PACU (on average 4 hours).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04824599, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.

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