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Status unknownNCT03966326Updated May 31, 2019

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

A Phase 4 interventional study of sevoflurane and fentanil and sevoflurane and fentanil plus PECS II block in Postoperative Pain, sponsored by Hospital de Base. Status unknown at 1 site in Brazil. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-05-31.

Sponsored by Hospital de Base · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2019), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Jul 2018, registered May 2019).
Phase
Phase 4
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Postoperative Pain

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Keywords

  • Mastectomy
  • (PECs) pectoral block
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In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's planned enrollment of 80 is close to the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Hospital de Base is the lead sponsor of 24 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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;
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Placebo comparator
    Placebo group

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

    Drug: sevoflurane and fentanil

  • Active comparator
    PECS II group

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

    Drug: sevoflurane and fentanil plus PECS II block

Interventions

  • Drugsevoflurane and fentanil

    Patients will receive standard general anesthesia

    Also known as: Standard general anesthesia

  • Drugsevoflurane and fentanil plus PECS II block

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

    Also known as: Standard general anesthesia plus PECS II block

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What researchers measure

Primary outcomes

  1. Pain Scores on the Visual Analogue Scale

    Quantify pain by Visual Analogue Scale (VAS, ranging from 0 to 10 cm, zero being found when the patient is no pain and ten, with maximum or un bearable pain

    Time frame: Within the first 24 hours after surgery

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Study locations

1 of 1 sites recruiting
  • Hospital de Base do Distrito Federal
    Brasilia, DF 70680250, Brazil
    Recruiting
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References and documents

Publications

  • 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. PubMed 29576125 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 31, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03966326
Lead sponsor
Hospital de Base
Responsible party
Fabricio Tavares Mendonca (Preceptor of anesthesiology medical residency, Hospital de Base) — Principal investigator
First posted
May 29, 2019
Start date
Jul 1, 2018
Primary completion
Dec 2019 (estimated)
Completion
Jul 2020 (estimated)
Last update
May 31, 2019

Study contacts

Fabricio T Mendonça, MD
Contact
correidofabricio@gmail.com
+5561981882640
Fabricio T Mendonça, MD
principal investigator · Hospital de Base do Distrito Federal

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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