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

NCT ID: NCT04135157

Last Updated: 2021-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2020-09-01

Brief Summary

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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

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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.

Conditions

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Anesthesia Analgesia Acute Pain Chronic Pain Pectoralis Nerve Block Erector Spine Plane Block Patient Controlled Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomization of the study will be done by a doctor who will not participate in patient follow-up with closed envelopes using computer generated generated random numbers.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors
The anesthesia doctor who will perform the peripheral nerve block will be informed with a sealed envelope by an independent assistant outside the study.

Study Groups

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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.

Group Type EXPERIMENTAL

Pectoralis nerve block II

Intervention Type PROCEDURE

PECS II block will be performed 30 min. before general anesthesia.

Erector spine plane block

Intervention Type PROCEDURE

ESP block will be performed 30 minutes before general anesthesia.

Control

In the control group, patients will have only general anesthesia. PCA is used for all the patients in the first 24 hours postoperatively.

Group Type ACTIVE_COMPARATOR

Control

Intervention Type OTHER

Only general anesthesia will be performed.

Interventions

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Pectoralis nerve block II

PECS II block will be performed 30 min. before general anesthesia.

Intervention Type PROCEDURE

Erector spine plane block

ESP block will be performed 30 minutes before general anesthesia.

Intervention Type PROCEDURE

Control

Only general anesthesia will be performed.

Intervention Type OTHER

Other Intervention Names

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PECS II ESP

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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CENGİZ KAYA (ckaya)

UNKNOWN

Sponsor Role collaborator

Ondokuz Mayıs University

OTHER

Sponsor Role lead

Responsible Party

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Caner Genç

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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CENGİZ KAYA, MD

Role: STUDY_DIRECTOR

Ondokuz Mayıs University Faculty of Medicine

Locations

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Ondokuz Mayıs University Faculty of Medicine

Samsun, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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PA191001001

Identifier Type: -

Identifier Source: org_study_id

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