Clinical trial NCT04824599: Regional Anesthesia and Partial Mastectomy
Official title: Interpectoral and Pectoserratus Plane Block vs Local Anesthetic Infiltration for Partial Mastectomy - a Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasm
Keywords: Segmental Mastectomy,
Analgesia
Regional anesthesia
Breast surgery
Lead sponsor: Karlstad Central Hospital
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


Eligibility criteria: 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

Primary outcomes:
measure: maximal pain in PACU measured with 11 point numerical rating scale (NRS)
timeFrame: measured at discharge from PACU (on average 4 hours).
measure: Intraoperative fentanyl use
timeFrame: Time is measured from start of the anesthesia until discharge to PACU (on average 3 hours)
Secondary outcomes:
measure: Postoperative analgesic use
timeFrame: measured at 24 hours postoperatively.
measure: Maximal postoperative nausea and vomiting(PONV) in PACU measured with 11 point numerical rating scale (NRS)
timeFrame: measured at discharge from PACU (on average 4 hours).
measure: Length of stay in PACU
timeFrame: on average 4 hours.
measure: Maximal postoperative nausea and vomiting(PONV) after discharge from PACU measured with 11 point numerical rating scale (NRS)
timeFrame: 24 hours
measure: Maximal pain after discharge from PACU measured with 11 point numerical rating scale (NRS)
timeFrame: 24 hours
Other outcomes:
Locations:
city: Karlstad
country: Sweden
facility: Central Hospital in Karlstad
state: Värmland
Study officials:
affiliation: Örebro University, Sweden
name: Ragnar Henningsson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.