NCT03966326

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for phase_4 postoperative-pain

Timeline
Completed

Started Jul 2018

Typical duration for phase_4 postoperative-pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 29, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

May 31, 2019

Status Verified

May 1, 2019

Enrollment Period

1.4 years

First QC Date

May 25, 2019

Last Update Submit

May 29, 2019

Conditions

Postoperative Pain

Keywords

Mastectomy(PECs) pectoral block

Outcome Measures

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

    Within the first 24 hours after surgery

Study Arms (2)

Placebo group

PLACEBO COMPARATOR

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

Drug: sevoflurane and fentanil

PECS II group

ACTIVE COMPARATOR

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

Drug: sevoflurane and fentanil plus PECS II block

Interventions

sevoflurane and fentanilDRUG

Patients will receive standard general anesthesia

Also known as: Standard general anesthesia
Placebo group
sevoflurane and fentanil plus PECS II blockDRUG

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
PECS II group

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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);

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Base do Distrito Federal

Brasília, Federal District, 70680250, Brazil

RECRUITING

Related Publications (2)

  • 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.

    PMID: 29576125BACKGROUND

  • 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.

    PMID: 37083738DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

SevofluraneFentanyl

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Fabricio T Mendonça, MD

    Hospital de Base do Distrito Federal

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabricio T Mendonça, MD

CONTACT

+5561981882640correidofabricio@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Preceptor of anesthesiology medical residency

Study Record Dates

First Submitted

May 25, 2019

First Posted

May 29, 2019

Study Start

July 1, 2018

Primary Completion

December 1, 2019

Study Completion

July 1, 2020

Last Updated

May 31, 2019

Record last verified: 2019-05

Locations

BR(1)