The Effect of Ultrasonography-guided Fascial Plane Blocks in Breast Cancer Surgery Patients

Breast Cancer Clinical Trial

Official title:

The Effect of Ultrasonography-guided Pectoserratus Plane Block, Erector Spina Plane Block and Serratus Anterior Plane Block on Postoperative Opioid Consumption, Recovery Quality and Chronic Pain in Breast Cancer Surgery Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06419504
• Other study ID #: 6/11
• Status: Recruiting
• Start date: May 17, 2024
• Est. completion date: November 15, 2024

Study information

• Verified date: May 2024
• Source: Antalya Training and Research Hospital
• Contact: Arzu Karaveli, M.D.
• Phone: +905325611300
• Email: arzukaraveli[@]sbu.edu.tr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study was to evaluate the efficacy of serratus anterior plane (SAP) block, pectoserratus plane (PECS II) block, and erector spinae plane (ESP) block on postoperative acute pain, quality of recovery and chronic pain in breast cancer surgery patients.

Description:

Breast cancer is the most common type of cancer in women. Although surgical treatment is effective and curative, it is associated with many complications in the postoperative period. Acute pain after surgery is one of them. Approximately half of women undergoing breast surgery describe significant post-operative pain (>5 on the Visual Analogue Scale; VAS) score that is not always effectively controlled by standard post-operative treatments. Poorly controlled postoperative pain has been associated with impaired functional recovery, delayed discharge from the post-anesthetic care unit, and prolonged hospital stay. In addition, poorly managed acute pain becomes chronic and is described as 'post-mastectomy pain syndrome'. Regional techniques can reduce acute and chronic postoperative pain. The development of ultrasonography (US)-guided regional anesthesia has led to the development of fascial plane blocks. Serratus anterior plan (SAP) block, pectoserratus plan (PECS II) block, and erector spina plan (ESP) block are frequently used for postoperative analgesia in patients undergoing breast surgery. he aim of this study was to evaluate the efficacy of serratus anterior plane (SAP) block, pectoserratus plane (PECS II) block, and erector spinae plane (ESP) block on postoperative acute pain, quality of recovery and chronic pain in breast cancer surgery patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: November 15, 2024
• Est. primary completion date: October 15, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• elective breast surgery (modified radical mastectomy, breast conserving surgery, simple mastectomy, axillary lymph node dissection, etc.),

• 18 to 65 years old,

• American Society of Anaesthesiology (ASA) score I-III

• body mass index (BMI) <32 kg/m2

Exclusion Criteria:

• contraindications to the block applications

• history of mental or neurological disorders

• history of chronic opioid use

• chronic alcoholism

• substance use

• treatment of chronic pain

• severe liver and kidney disease

• uncooperative patients

• patients scheduled for bilateral mastectomy

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• SAP block group
US-guided SAP block is performed approximately 30 minutes before the surgery in patients undergoing breast cancer surgery in a separate regional anesthesia room with standard anesthesia monitoring.
• PECS II block group
US-guided PECS II block is performed approximately 30 minutes before the surgery in patients undergoing breast cancer surgery in a separate regional anesthesia room with standard anesthesia monitoring.
• ESP block group
US-guided ESP block is performed approximately 30 minutes before the surgery in patients undergoing breast cancer surgery in a separate regional anesthesia room with standard anesthesia monitoring.
• Control group
No intervention

Locations

Country	Name	City	State
Turkey	University of Health Sciences, Antalya Training and Researh Hospital	Antalya	Muratpasa

Sponsors (1)

Lead Sponsor	Collaborator
Antalya Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Fujii T, Shibata Y, Akane A, Aoki W, Sekiguchi A, Takahashi K, Matsui S, Nishiwaki K. A randomised controlled trial of pectoral nerve-2 (PECS 2) block vs. serratus plane block for chronic pain after mastectomy. Anaesthesia. 2019 Dec;74(12):1558-1562. doi: 10.1111/anae.14856. Epub 2019 Sep 19. — View Citation

Wang S, Shi J, Dai Y, Zhang J, Liu Q, Yang P, Zhu N. The effect of different nerve block strategies on the quality of post-operative recovery in breast cancer patients: A randomized controlled study. Eur J Pain. 2024 Jan;28(1):166-173. doi: 10.1002/ejp.2178. Epub 2023 Sep 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative opioid consumption	All patients will receive a standard patient controlled analgesia (PCA) protocol. The postoperative opioid consumption will only be recorded.	24 hours
Secondary	recovery quality	The Quality of Recovery-15 (QoR-15) is a 15-question questionnaire validated to assess poetoperative recovery. This questionnaire assesses patients' pain, physical comfort, physical independence, psychological support, and emotional status in the erly postoperative period. The patient is asked to express their status scoring from 0 to 10; therefore, the total score ranges from 0 to 150 points.	5 minutes
Secondary	chronic pain	Patients will be telephoned 3 months after the operation and the presence, localization, and intensity of the pain, its character, and its relation with rest and/or activity will be recorded by asking only verbally.	3 months