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Clinical Trials/NCT04135157
NCT04135157
Completed
Not Applicable

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

Ondokuz Mayıs University1 site in 1 country90 target enrollmentJuly 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anesthesia
Sponsor
Ondokuz Mayıs University
Enrollment
90
Locations
1
Primary Endpoint
Opioid consumption in the first 24 hours after surgery
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2019
End Date
September 1, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Ondokuz Mayıs University
Responsible Party
Principal Investigator
Principal Investigator

Caner Genç

Medical Doctor

Ondokuz Mayıs University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Opioid consumption in the first 24 hours after surgery

Time Frame: 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 Outcomes

  • Remifentanil consumption during the surgery(During the surgery)
  • Post-operative acute pain(1 day)
  • The incidences of post-operative nausea and vomiting (PONV)(1 day)
  • The number of patient required rescue analgesia(1 day)
  • Post-operative chronic pain(3. month after surgery)

Study Sites (1)

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