Effects of Interpectoral-Pectoserratus Plane Block After Breast Cancer Surgery

The Effects of Intraoperative and Preoperative Interpectoral -Pectoserratus Plan Block on Postoperative Pain, Amount of Analgesic Use, and Shoulder Joint Range of Motion in Patients Who Had Breast Cancer Surgery

The aim of this study: It was aimed to observe the effects of intraoperative and preoperative PECS II block on postoperative pain, amount of analgesic use and shoulder joint range of motion in patients who underwent breast cancer surgery.

This research was planned as an observational study. For this purpose, patients who underwent breast cancer surgery in İzmir Bakırçay University Çiğli Training and Research Hospital General Surgery Clinic will be included in the study at the 1st hour after the operation. Patients who underwent preoperative Interpectoral - Pectoserratus Plan Block in the operation will be included in Group 1, patients who have been applied Interpectoral - Pectoserratus Plan Block between the muscle planes by the intraoperative surgeon will be included in Group 2, and patients who have not applied any block will be included in Group 3. Pain numerical rating scale (numering Rating Scale) at postoperative 1st, 2nd, 6th, 12th and 24th hours in patients, patient recovery scores (QoR15 Turkish version), amount of tramadol used in patient-controlled analgesia, time to first rescue analgesia, adverse events (pneumothorax, nausea, vomiting, itching, hematoma, allergic reactions) and quality of life, shoulder joint range of motion, hand grip strength (also on day 1) and disability level will be measured on postoperative day 10.

H0- Preoperative interpectoral - pectoserratus plane block affects the level of postoperative pain.

H1- Preoperativeinterpectoral - pectoserratus plane block does not affect the level of postoperative pain.

H2- Intraoperative interpectoral - pectoserratus plane block affects postoperative pain level H3- Intraoperative interpectoral - pectoserratus plane blockk does not affect the level of postoperative pain.

Study Overview

• Status: Not yet recruiting
• Conditions: Quality of Life; Pain, Postoperative; Disability Physical
• Intervention / Treatment: Other: Preoperative Interpectoral - Pectoserratus Plane Block; Other: Intraoperative Interpectoral - Pectoserratus Plane Block; Other: Non Block

Detailed Description

Breast cancer is the most common type of cancer among women and the most common cause of death worldwide. While there has been a serious decrease in the mortality rate due to developments in diagnosis and treatment, there have been serious increases in functional disability and disability due to the disease. Breast cancer can lead to various functional losses due to the nature of the disease itself, radical surgical interventions and radiotherapy applications. These include shoulder dysfunction (pain and limitation of joint movement), locomotor system disorders such as upper extremity muscle strength loss and lymphedema, as well as psychological and cosmetic problems, and as a result, these problems affect the quality of life (QOL) of individuals (1).

Firstly, Blanco et al. Ultrasound-guided pectoralis nerve II block (Interpectoral and pectoserratus plan block - PECS II block), described by MD, is increasingly used for analgesia in breast surgery (2). It has been reported that PECS II block is effective in reducing postoperative pain intensity and opioid consumption (3). It is safe and relatively simple to apply as an interfascial plane block, and there is no sympathetic blockade (4). The PECS II block consists of two interfascial injections of local anesthetics: 1) between the pectoralis minor and serratus anterior muscles, 2) between the pectoralis major and pectoralis minor muscles at the level of the third rib. Local anesthetic injection into these planes; It is expected to block the lateral pectoral nerve, medial pectoral nerve, anterior branches of the thoracic intercostal nerves, and long thoracic nerves (5). Recently, the types of local anesthesia used during radical surgery may decrease the postoperative pain levels and recovery times of the patients. The effect of these intraoperative or postoperative blocks on the patients' clinical status in the postoperative period has not been compared before.

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Ömer Faruk Altaş, 1; Phone Number: +905366533992; Email: omerfarukaltas@hotmail.com
• Study Contact Backup: Name: Elif Umay Altaş, 2; Phone Number: +905053076622; Email: elifumay.altas@bakircay.edu.tr

Study Locations

• Turkey
  • İzmir, Turkey
    • Izmir Bakircay University Cigli Training and Research Hospital
    • Contact: Ömer Faruk ALTAŞ, 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Sixty patients aged >18 years old who has breast cancer surgery with intraoperative or preoperative interpectoral - pectoserratus plane block o non block will be included in the study. Patients will be randomly divided into three groups including 20 patients each, postoperative 1st hour.

Description

Inclusion Criteria:

• Having had a unilateral breast cancer operation
• Signing the voluntary consent form

Exclusion Criteria:

• BMI >35kg/m2 and <20kg/m2
• Having a rheumatological disease (rheumatoid arthritis, etc.),
• Having neuromuscular disease
• Having a disease that will add shoulder joint movement (arthritis, prosthesis, fracture sequela, etc.)
• Having neuropathy, alcoholism, psychiatric disorder
• Chronic opioid use
• being pregnant
• Patient's refusal to use patient-controlled analgesia
• History of uncontrolled hypertension, diabetes, heart failure, liver failure, kidney failure and/or cerebrovascular disease

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Preoperative Interpectoral - Pectoserratus Plane Block; The block will be done by the Anesthesiologist.	Other: Preoperative Interpectoral - Pectoserratus Plane Block; Pain numerical rating scale (numering Rating Scale) at postoperative 1st, 2nd, 6th, 12th and 24th hours in patients, patient recovery scores at 24th hour (QoR15 Turkish version), amount of tramadol used in patient-controlled analgesia, time to first rescue analgesia , adverse events (pneumothorax, nausea, vomiting, pruritus, hematoma, allergic reactions) and hand grip strength on the postoperative 1st day, quality of life, shoulder joint range of motion, and disability level will be measured on the postoperative 10th day.
Intraoperative Interpectoral - Pectoserratus Plane Block; The block will be made by the surgeon.	Other: Intraoperative Interpectoral - Pectoserratus Plane Block; Pain numerical rating scale (numering Rating Scale) at postoperative 1st, 2nd, 6th, 12th and 24th hours in patients, patient recovery scores at 24th hour (QoR15 Turkish version), amount of tramadol used in patient-controlled analgesia, time to first rescue analgesia , adverse events (pneumothorax, nausea, vomiting, pruritus, hematoma, allergic reactions) and hand grip strength on the postoperative 1st day, quality of life, shoulder joint range of motion, and disability level will be measured on the postoperative 10th day.
Non Block; will not be blocked.	Other: Non Block; Pain numerical rating scale (numering Rating Scale) at postoperative 1st, 2nd, 6th, 12th and 24th hours in patients, patient recovery scores at 24th hour (QoR15 Turkish version), amount of tramadol used in patient-controlled analgesia, time to first rescue analgesia , adverse events (pneumothorax, nausea, vomiting, pruritus, hematoma, allergic reactions) and hand grip strength on the postoperative 1st day, quality of life, shoulder joint range of motion, and disability level will be measured on the postoperative 10th day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative opioid consumption	Tramadol consumption in the first 24 hours after surgery	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NRS scores	NRS scores in the first 24 hours after surgery	1., 2., 6., 12., 24. hour
Quality of Recovery	QoR-15 questionairre QoR-15 questionairre	24th hours
The disability levels of the patients due to shoulder dysfunction.	The Shoulder Pain and Disability Index questionnaire will be used to determine The disability levels of the patients due to shoulder dysfunction. (Quick dash)	10th day
Hand grip muscle strength.	Hand grip muscle strength will be measured with a handheld dynamometer.	24th hour, 10th day
Quality of Life (Short Form 36)	The SF-36 Quality of Life scale will be used to assess quality of life.	24th hour, 10th day
Shoulder joint range of motion	Shoulder joint range of motion will be measured with a goniometer.	10th day

Collaborators and Investigators

• Sponsor: Izmir Bakircay University
• Investigators: Principal Investigator: Ömer Faruk Altaş, 1, Izmir Bakircay University

Study record dates

Study Major Dates

• Study Start (Anticipated): October 6, 2022
• Primary Completion (Anticipated): January 6, 2023
• Study Completion (Anticipated): April 6, 2023

Study Registration Dates

• First Submitted: October 2, 2022
• First Submitted That Met QC Criteria: October 2, 2022
• First Posted (Actual): October 5, 2022

Study Record Updates

• Last Update Posted (Actual): October 5, 2022
• Last Update Submitted That Met QC Criteria: October 2, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Breast Cancer; İnterpectoral plane block; Pectoserratus plane block; PECS II Block
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 712

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No