Pectoralis and Serratus Nerve Blocks for Mastectomy: a Prospective, Randomized, Single-blind Trial

NCT ID: NCT03966326

Last Updated: 2019-05-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-01
• Study Completion Date: 2020-07-31

Brief Summary

Pectoral nerve block provides a good alternative to epidural or paravertebral block with a lower risk for the patient and that is shown as an optimal anesthetic option with reduction in postoperative pain, anesthetic and opioid consumption. The main objective of this study is to evaluate the quality of the perioperative analgesia of the PECS block in patients electively escalated for the accomplishment of mastectomy under general anesthesia.

Detailed Description

The advent of ultrasound made possible greater safety and the creation of new peripheral blocks that aim to reduce the morbidity of the anesthetic technique on the cancer patient. Pectoral nerve block (PEC Block) is technically simple and easily reproducible. Inspired by the infraclavicular approach, it aims at the anesthesia of the pectoral, intercostobrachial, intercostal III-IV-V-VI nerves and the long thoracic nerve 8 being a safe, reproducible technique with little discomfort for the patients, with few complications and allowing a good control of acute pain.

The hypothesis is that the realization of pectoral nerve block provides a good alternative to epidural or paravertebral block with a lower risk for the patient and that is shown as an optimal anesthetic option with reduction in postoperative pain, anesthetic and opioid consumption. Main objective is the evaluation of postoperative pain through opioid consumption in the first 24 hours postoperatively.

Patients will undergo a prospective, randomized, single blind, placebo controlled study in which the examiners responsible for the postoperative evaluation will not know which of the two groups were randomly assigned: 40 patients in the Control and 40 patients in the PECS Group . Patients will be randomized through a list generated by www.randomizer.org into two groups.

Patients will receive standard monitoring, pre-anesthetic medication with midazolam 0.05 mg / kg EV. All patients will receive balanced general anesthesia with fentanyl 2 mcg / kg, lidocaine 2 mg / kg, propofol 1-2 mg / kg, cisatracurium 0.15 mg / kg or Rocuronium 0.6 mg / kg. The PECS II group will receive an injection of 20mL of 0.5% Ropivacaine between the serratus and the smaller pectoralis and 10mL of 0.5% ropivacaine between the pectoralis major and minor muscles with the aid of ultrasonography. Maintenance of anesthesia in the two groups: general anesthesia balanced with sevoflurane (with and fraction expired from 1 to 3%, to maintain BIS between 40 and 60). Prophylaxis for postoperative nausea and vomiting will be performed with slow intravenous administration following the anesthetic induction of Dexamethasone 4 mg, and at the end of the surgery slow intravenous administration of Ondansetron 4 mg. At the end of surgery, patients in both groups will receive Dipyrone 2 g and Parecoxib 40 mg. Patients will be evaluated in the postoperative times: T1: arrival at the PACU, T2: 3 hours postoperatively or discharge from the PACU), T3: 12 hours postoperative, T4: 24 hours postoperative.

Conditions

Postoperative Pain

Keywords

Mastectomy; (PECs) pectoral block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo group

Patients in placebo group will receive general balanced inhaled anesthesia with sevoflurane and fentanil

Group Type: PLACEBO_COMPARATOR

sevoflurane and fentanil

Intervention Type: DRUG

Patients will receive standard general anesthesia

PECS II group

Patients in PECS II group will receive general balanced inhaled anesthesia with sevoflurane and fentanil

Group Type: ACTIVE_COMPARATOR

sevoflurane and fentanil plus PECS II block

Intervention Type: DRUG

Pacients will receive standard general anesthesia with sevoflurane and fentanil associated to PECS II block

Interventions

sevoflurane and fentanil

Patients will receive standard general anesthesia

Intervention Type: DRUG

sevoflurane and fentanil plus PECS II block

Pacients will receive standard general anesthesia with sevoflurane and fentanil associated to PECS II block

Intervention Type: DRUG

Other Intervention Names

Standard general anesthesia; Standard general anesthesia plus PECS II block

Eligibility Criteria

Inclusion Criteria

• Female patients, aged 18 to 60 years, electively scheduled to perform mastectomy in the Base Hospital of the Federal District;
• Physical State 1, 2 or 3 the American Society of Anesthesiology (ASA);

Exclusion Criteria

• Patients with unstable angina
• Patient with poorly controlled asthma
• Substance abuse
• Heart failure, greater than first degree atrioventricular block
• Pregnant women
• Patients with allergy to dipyrone, morphine;
• Patients with chronic pain;
• Patients with severe hepatic disease;
• Patients with severe kidney disease;
• Patients with neurological diseases;
• Included patients in other clinical studies currently or in the past three months under general anesthesia;
• Patients who refuse to participate in the study;
• Any other condition that, in the opinion of the investigator, may pose a risk to the patient or interfere with the study objectives;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hospital de Base

OTHER

Sponsor Role: lead

Responsible Party

Fabricio Tavares Mendonca

Preceptor of anesthesiology medical residency

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fabricio T Mendonça, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Base do Distrito Federal

Locations

Hospital de Base do Distrito Federal

Brasília, Federal District, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Fabricio T Mendonça, MD

Role: CONTACT

Phone: +5561981882640

Email: correidofabricio@gmail.com

Facility Contacts

Jamil Elias, MD

Role: primary

Viviane Rezende, MD

Role: backup

References

O'Scanaill P, Keane S, Wall V, Flood G, Buggy DJ. Single-shot pectoral plane (PECs I and PECs II) blocks versus continuous local anaesthetic infusion analgesia or both after non-ambulatory breast-cancer surgery: a prospective, randomised, double-blind trial. Br J Anaesth. 2018 Apr;120(4):846-853. doi: 10.1016/j.bja.2017.11.112. Epub 2018 Feb 14.

Reference Type: BACKGROUND

PMID: 29576125 (View on PubMed)

Mendonca FT, Nascimento LFC, Veloso NM, Basto GCP. Long-term Efficacy of Pectoserratus Plane Block (PSPB) for Prevention of Post-mastectomy Pain Syndrome: Extended Follow-up From a Randomized Controlled Trial. Clin J Pain. 2023 Jul 1;39(7):334-339. doi: 10.1097/AJP.0000000000001118.

Reference Type: DERIVED

PMID: 37083738 (View on PubMed)

Other Identifiers

PECS II block

Identifier Type: -

Identifier Source: org_study_id