Clinical trial NCT04135157: Pectoral Nerve Block II and Erector Spine Plane Block in Breast Cancer Surgery
Official title: Research of the Effects of Pectoralis Nerve Block II and Erector Spina Plan Block in Breast Cancer Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Analgesia
Acute Pain
Chronic Pain
Pectoralis Nerve Block
Erector Spine Plane Block
Patient Controlled Analgesia
Keywords: Regional Anesthesia
Acute and chronical pain
Pectoralis nerve block
Erector spine plane block
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
Collaborators: name: CENGİZ KAYA (ckaya)
First posted: 2019-10-22
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: SUPPORTIVE_CARE

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.

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
* Patients with previous breast surgery except diagnostic biopsies
* Patients who do not want to participate

Primary outcomes:
measure: Opioid consumption in the first 24 hours after surgery
timeFrame: 1 day
Secondary outcomes:
measure: Post-operative acute pain
timeFrame: 1 day
measure: Remifentanil consumption during the surgery
timeFrame: During the surgery
measure: The incidences of post-operative nausea and vomiting (PONV)
timeFrame: 1 day
measure: The number of patient required rescue analgesia
timeFrame: 1 day
measure: Post-operative chronic pain
timeFrame: 3. month after surgery
Other outcomes:
measure: The time of first analgesic demand from the PCA device.
timeFrame: 1 day
Locations:
city: Samsun
country: Turkey
facility: Ondokuz Mayıs University Faculty of Medicine
Study officials:
affiliation: Ondokuz Mayıs University Faculty of Medicine
name: CENGİZ KAYA, MD
role: STUDY_DIRECTOR
References: