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

NCT04135157 | Completed

• 1 other identifier: PA191001001
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Opioid consumption in the first 24 hours after surgery

  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.

  1 day

Secondary Outcomes (5)

• Post-operative acute pain

  1 day

• Remifentanil consumption during the surgery

  During the surgery

• 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

Other Outcomes (1)

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

  1 day

Study Arms (2)

PECS II or ESP

EXPERIMENTAL

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.

Procedure: Pectoralis nerve block II; Procedure: Erector spine plane block

Control

ACTIVE COMPARATOR

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

Other: Control

Interventions

Pectoralis nerve block II PROCEDURE

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

Also known as: PECS II

PECS II or ESP

Erector spine plane block PROCEDURE

ESP block will be performed 30 minutes before general anesthesia.

Also known as: ESP

PECS II or ESP

Control OTHER

Only general anesthesia will be performed.

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Women with breast cancer having segmental mastectomy and sentinel lymph node biopsy (SLNB)
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA 1-2 patients between the age of 18-65, scheduled for elective unilateral segmental mastectomy + sentinel lymph node biopsy

You may not qualify if:

• 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

Sponsors & Collaborators

• Ondokuz Mayıs University: lead
• CENGİZ KAYA (ckaya): collaborator

Study Sites (1)

Ondokuz Mayıs University Faculty of Medicine

Samsun, 55270, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Agnosia; Acute Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain

Study Officials

• CENGİZ KAYA, MD

  Ondokuz Mayıs University Faculty of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The anesthesia doctor who will perform the peripheral nerve block will be informed with a sealed envelope by an independent assistant outside the study.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: 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.

Study Record Dates

• First Submitted: October 19, 2019
• First Posted: October 22, 2019
• Study Start: July 1, 2019
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: August 18, 2021

Record last verified: 2021-08

Locations

TU (1)