Pectoral Nerve Block II and Erector Spine Plane Block in Breast Cancer Surgery

Research of the Effects of Pectoralis Nerve Block II and Erector Spina Plan Block in Breast Cancer Surgery

This study evaluates the analgesic effects of pectoralis nerve block (PECS II) and erector spinae plane block (ESP) in patients having segmental mastectomy and sentinel lymph node biopsy (SLNB). Each one-third of patients will have ESP block and pectoralis nerve block (PECS II) 30 min before general anesthesia , while other one-third of patients will have only general anesthesia.

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Analgesia; Acute Pain; Anesthesia; Patient Controlled Analgesia; Pectoralis Nerve Block; Erector Spine Plane Block
• Intervention / Treatment: Procedure: Pectoralis nerve block II; Procedure: Erector spine plane block; Other: Control

Detailed Description

It has been proven that PECS II and ESP both supply effective analgesia in the first 24 hours after mastectomy. But they do so by different mechanishms.

This study is to survey that ESP and PECS II may supply acute and chronic analgesia by reducing pain scores in the first 24 hours and 3 months after the surgery, also the comparison of the analgesic activity among themselves for acute / chronic pain and opioid consumption will be searched.

In this study patients are divided into three groups. Patients in PECS group will have PECS II block in a separate section from the operating rooms (PNB practice room). In addition, patient controlled analgesia (PCA) will be used in the first 24 hours postoperatively.

Patients in ESP group will have ESP block in a separate section from the operating rooms (PNB practice room). In addition, PCA will be used in the first 24 hours postoperatively.

Patients in control group will not be performed nerve block. Only general anesthesia (GA) will be performed in the operation room. In addition, PCA will be used in the first 24 hours postoperatively.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Samsun, Turkey, 55270
    • Ondokuz Mayıs University Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• ASA 1-2 patients between the age of 18-65, scheduled for elective unilateral segmental mastectomy + sentinel lymph node biopsy

Exclusion Criteria:

• Age <18 or> 65, ASA 3-4 patients
• Obesity (> 100 kg, BMI> 35 kg / m2)
• Patients undergoing bilateral mastectomy
• Pregnancy
• Contraindication of regional anesthesia (coagulopathy, abnormal INR, thrombocytopenia, infection at the injection site)
• Serious renal, cardiac, hepatic disease
• Hypersensitivity to local anesthetics or a history of allergy
• Patients with a history of opioid use longer than four weeks
• Patients with psychiatric disorders or communication difficulties
• Patients with chest deformity
• Patients with previous breast surgery except diagnostic biopsies
• Patients who do not want to participate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PECS II or ESP; PECS II or ESP block are performed 30 minutes before general anesthesia. PCA is used for all the patients in the first 24 hours postoperatively.	Procedure: Pectoralis nerve block II; PECS II block will be performed 30 min. before general anesthesia.; Other Names: PECS II; Procedure: Erector spine plane block; ESP block will be performed 30 minutes before general anesthesia.; Other Names: ESP
Active Comparator: Control; In the control group, patients will have only general anesthesia. PCA is used for all the patients in the first 24 hours postoperatively.	Other: Control; Only general anesthesia will be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid consumption in the first 24 hours after surgery	Morphine consumption in the first 24 hours will be counted by IV PCA. Patients will be able to request opioids via PCA device when the vas score is 4 points or more when the arm is in the resting position.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative acute pain	Pain status will be evaluated based on VAS scores in two different positions: arm at rest and arm in abduction. Pain status will be evaluated at 1-3-6-12-24. hours after surgery. Each VAS is scores 0-10. (0=no pain ; 10=pain as bad as can be)	1 day
Remifentanil consumption during the surgery	Following induction of general anesthesia, anesthesia maintenance will be continued with sevoflurane to BIS 40-60 (bispectral index). When the BIS is between 40-60, remifentanil infusion rate will be changed considering ± 20% changes in blood pressure compared to baseline values.The total amount of remifentanil consumed will be recorded.	During the surgery
The incidences of post-operative nausea and vomiting (PONV)	The patients will be evaluated according to the five-stage verbal descriptive PONV scale. If it is 3 points or more, ondansetron 4 mg IV will be administered. Wait for 8 hours for the next dose of ondansetron. (0 = None, 1 = Slight nausea, 2 = Moderate nausea, 3 = Once vomiting, 4 = vomiting more than one)	1 day
The number of patient required rescue analgesia	The number of patient requires rescue analgesic will be recorded at 1-3-6-12-24. hours after surgery	1 day
Post-operative chronic pain	Pain status will be evaluated in the third month after surgery based on VAS scores in two different positions: arm at rest and arm in abduction. Each VAS is scores 0-10. (0=no pain ; 10=pain as bad as can be)	3. month after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The time of first analgesic demand from the PCA device.	The time of first analgesic demand was defined as the time to first PCA bolus after patient PACU arrival.	1 day

Collaborators and Investigators

• Sponsor: Ondokuz Mayıs University
• Collaborators: CENGİZ KAYA (ckaya)
• Investigators: Study Director: Cengiz KAYA, MD, Ondokuz Mayıs University Faculty of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): September 1, 2020
• Study Completion (Actual): September 1, 2020

Study Registration Dates

• First Submitted: October 19, 2019
• First Submitted That Met QC Criteria: October 19, 2019
• First Posted (Actual): October 22, 2019

Study Record Updates

• Last Update Posted (Actual): August 18, 2021
• Last Update Submitted That Met QC Criteria: August 12, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Regional Anesthesia; Acute and chronical pain; Pectoralis nerve block; Erector spine plane block
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Acute Pain
• Other Study ID Numbers: PA191001001

Drug and device information, study documents

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