Regional Anesthesia and Partial Mastectomy

Breast Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04824599
• Other study ID #: LIVFOU-930411
• Status: Completed
• Phase: N/A
• Start date: February 19, 2021
• Est. completion date: May 1, 2022

Study information

• Verified date: September 2023
• Source: Karlstad Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasm
• Breast Neoplasms

Intervention

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.
• Local anesthetic infiltration
Ropivacaine is administered by surgeon prior to scrubbing and following the removal of the tumor.
• 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

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.

Locations

Country	Name	City	State
Sweden	Central Hospital in Karlstad	Karlstad	Värmland

Sponsors (1)

Lead Sponsor	Collaborator
Karlstad Central Hospital

Country where clinical trial is conducted

Sweden, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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	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 at 24 hours postoperatively.
Secondary	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 at discharge from PACU (on average 4 hours).
Secondary	Length of stay in PACU	Is an dependant of multiple factors and an important measurement that can indicate beneficial therapeutic choice.	on average 4 hours.
Secondary	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.	24 hours
Secondary	Maximal pain after discharge from PACU measured with 11 point numerical rating scale (NRS)	NRS scale is a validated for assessment of pain.	24 hours