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

Not Applicable

Completed

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

• Registration Number: NCT04135157
• Lead Sponsor: Ondokuz Mayıs University

Brief Summary

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.

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 Timeline

• Study Start: 2019-07-01
• Study First Submitted: 2019-10-19
• Study First Submitted QC: 2019-10-19
• Study First Posted: 2019-10-22
• Primary Completion: 2020-09-01
• Study Completion: 2020-09-01
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-12
• Last Update Posted: 2021-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PECS II or ESP	Pectoralis nerve block II	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.
PECS II or ESP	Erector spine plane block	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.
Control	Control	In the control group, patients will have only general anesthesia. PCA is used for all the patients in the first 24 hours postoperatively.

Primary Outcome Measures

Name	Time	Method
Opioid consumption in the first 24 hours after surgery	1 day	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.

Secondary Outcome Measures

Name	Time	Method
Remifentanil consumption during the surgery	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.
Post-operative acute pain	1 day	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)
The incidences of post-operative nausea and vomiting (PONV)	1 day	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)
The number of patient required rescue analgesia	1 day	The number of patient requires rescue analgesic will be recorded at 1-3-6-12-24. hours after surgery
Post-operative chronic pain	3. month after surgery	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)

Trial Locations

Locations (1)

Ondokuz Mayıs University Faculty of Medicine; 🇹🇷 Samsun, Turkey