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

O

Ondokuz Mayıs University

Status

Completed

Conditions

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

Treatments

Procedure: Pectoralis nerve block II
Other: Control
Procedure: Erector spine plane block

Study type

Interventional

Funder types

Other

Identifiers

NCT04135157
PA191001001

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 patients

Sex

Female

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

90 participants in 2 patient groups

PECS II or ESP
Experimental group
Description:
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.
Treatment:
Procedure: Erector spine plane block
Procedure: Pectoralis nerve block II
Control
Active Comparator group
Description:
In the control group, patients will have only general anesthesia. PCA is used for all the patients in the first 24 hours postoperatively.
Treatment:
Other: Control

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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