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出境医 / 临床实验 / Pectoralis and Serratus Nerve Blocks for Mastectomy: a Prospective, Randomized, Single-blind Trial

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

Study Description
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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: sevoflurane and fentanil Drug: sevoflurane and fentanil plus PECS II block Phase 4

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.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pectoralis and Serratus Nerve Blocks for Mastectomy: a Prospective, Randomized, Single-blind, Controlled Trial
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : July 2020
Arms and Interventions
Arm Intervention/treatment
Placebo Comparator: Placebo group
Patients in placebo group will receive general balanced inhaled anesthesia with sevoflurane and fentanil
Drug: sevoflurane and fentanil
Patients will receive standard general anesthesia
Other Name: Standard general anesthesia

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
Pacients will receive standard general anesthesia with sevoflurane and fentanil associated to PECS II block
Other Name: Standard general anesthesia plus PECS II block

Outcome Measures
Primary Outcome Measures :
  1. Pain Scores on the Visual Analogue Scale [ Time Frame: Within the first 24 hours after surgery ]
    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


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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;
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Fabricio T Mendonça, MD +5561981882640 correidofabricio@gmail.com

Locations
Layout table for location information
Brazil
Hospital de Base do Distrito Federal Recruiting
Brasilia, DF, Brazil, 70680250
Contact: Jamil Elias, MD    556133151588    uamphbdf@gmail.com   
Contact: Viviane Rezende, MD    556133151331    vrezende@icab.med.br   
Sponsors and Collaborators
Hospital de Base
Investigators
Layout table for investigator information
Principal Investigator: Fabricio T Mendonça, MD Hospital de Base do Distrito Federal
Tracking Information
First Submitted Date  ICMJE May 25, 2019
First Posted Date  ICMJE May 29, 2019
Last Update Posted Date May 31, 2019
Actual Study Start Date  ICMJE July 1, 2018
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 28, 2019)
Pain Scores on the Visual Analogue Scale [ Time Frame: Within the first 24 hours after surgery ]
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pectoralis and Serratus Nerve Blocks for Mastectomy: a Prospective, Randomized, Single-blind Trial
Official Title  ICMJE Pectoralis and Serratus Nerve Blocks for Mastectomy: a Prospective, Randomized, Single-blind, Controlled Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Postoperative Pain
Intervention  ICMJE
  • Drug: sevoflurane and fentanil
    Patients will receive standard general anesthesia
    Other Name: Standard general anesthesia
  • Drug: sevoflurane and fentanil plus PECS II block
    Pacients will receive standard general anesthesia with sevoflurane and fentanil associated to PECS II block
    Other Name: Standard general anesthesia plus PECS II block
Study Arms  ICMJE
  • Placebo Comparator: Placebo group
    Patients in placebo group will receive general balanced inhaled anesthesia with sevoflurane and fentanil
    Intervention: Drug: sevoflurane and fentanil
  • Active Comparator: PECS II group
    Patients in PECS II group will receive general balanced inhaled anesthesia with sevoflurane and fentanil
    Intervention: Drug: sevoflurane and fentanil plus PECS II block
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 28, 2019)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03966326
Other Study ID Numbers  ICMJE PECS II block
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fabricio Tavares Mendonca, Hospital de Base
Study Sponsor  ICMJE Hospital de Base
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Fabricio T Mendonça, MD Hospital de Base do Distrito Federal
PRS Account Hospital de Base
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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