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NCT Number: NCT04135157

Pectoral Nerve Block II and Erector Spine Plane 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.

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Key information

Conditions

Anesthesia Acute Pain Agnosia Analgesia Chronic Pain Erector Spine Plane Block Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Patient Controlled Analgesia Pectoralis Nerve Block Perceptual Disorders Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ondokuz Mayıs University Faculty of Medicine

Samsun, 55270, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pectoralis nerve block II

Procedure

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

Other names: PECS II

Erector spine plane block

Procedure

ESP block will be performed 30 minutes before general anesthesia.

Other names: ESP

Control

Other

Only general anesthesia will be performed.

Primary outcomes

  1. 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

  1. Post-operative acute pain

    Time frame: 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)

  2. Remifentanil consumption during the surgery

    Time frame: 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.

  3. The incidences of post-operative nausea and vomiting (PONV)

    Time frame: 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)

  4. The number of patient required rescue analgesia

    Time frame: 1 day

    The number of patient requires rescue analgesic will be recorded at 1-3-6-12-24. hours after surgery

  5. Post-operative chronic pain

    Time frame: 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)

Other outcomes

  1. The time of first analgesic demand from the PCA device.

    Time frame: 1 day

    The time of first analgesic demand was defined as the time to first PCA bolus after patient PACU arrival.

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Collaborators

  • CENGİZ KAYA (ckaya)

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 22, 2019
Registry last updated
Aug 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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