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Efficacy of Pectoral Nerve Block for Breast Reduction Surgery

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ClinicalTrials.gov Identifier: NCT03857386
Recruitment Status : Completed
First Posted : February 28, 2019
Last Update Posted : April 30, 2019
Sponsor:
Information provided by (Responsible Party):
Arzu Karaveli, Antalya Training and Research Hospital

Study Description
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Brief Summary:
The purpose of the study is to evaluate the efficacy of PECS block applied to patients undergoing bilateral breast reduction surgery on postoperative analgesia compared to local infiltration anesthesia.

Condition or disease Intervention/treatment
Nerve Blocks Breast Surgery Postoperative Pain Procedure: PECS group Procedure: Control group

Detailed Description:
Pectoral nerve block (PECS block) has been developed as an alternative to thoracic paravertebral and/or thoracic epidural blocks in recent years. It is frequently applied for postoperative analgesia especially in breast cancer surgery and subpectoral breast prosthesis.
Study Design
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Study Type : Observational
Actual Enrollment : 53 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Comparison of The Effects of Pectoral Nerve Block and Local Infiltration Anesthesia on Postoperative Analgesia for Breast Reduction Surgery
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : March 1, 2018
Actual Study Completion Date : May 1, 2018
Groups and Cohorts
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Group/Cohort Intervention/treatment
PECS group
Preoperative bilateral PECS I + PECS II Pecs block performed by anaesthetist using ultrasound guidance in plane approach
 Procedure: PECS group
Pecs block performed using ultrasound guidance
Other Name: Regional anesthesia in breast surgery
Control group
Bilateral local anesthesia infiltration Local infiltration anesthesia performed by surgeon during the operation
 Procedure: Control group
Local infiltration anesthesia performed during the operation
Other Name: Regional anesthesia in breast surgery


Outcome Measures
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Primary Outcome Measures :
  1. postoperative visual analog scale (VAS) score [ Time Frame: postoperative 0, 1, 3, 6, 9, and 12 hours ]
    Postoperative pain assessment will be performed using the VAS score (VAS 0 = no pain, VAS 10 = most severe pain possible). The VAS scores will be recorded at postoperative 0, 1, 3, 6, 9, and 12 hours.


Secondary Outcome Measures :
  1. analgesia consumption [ Time Frame: 12 hours ]
    postoperative

  2. length of hospital [ Time Frame: 4 days ]
    recorded at the following time after surgery

  3. analgesia consumption [ Time Frame: during the surgery ]
    intraoperative


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study included patients with ASA I-II, 18-65 years old, with a BMI ≤ 40 kg/m2 and undergoing elective breast reduction operation under general anesthesia.
Criteria

Inclusion Criteria:

  • American Society of Anesthesiology (ASA) I-II
  • body mass index (BMI) ≤40 kg/m2
  • elective bilateral breast reduction surgery

Exclusion Criteria:

  • declining to give written informed consent
  • ASA III and above
  • under 18 years of age or over 65 years of age
  • history of allergy against to the local anesthetics,
  • controendication of peripheral block or local anesthetic infiltration (local infection, coagulopathy, etc.)
  • history of breast surgery
  • treatment due to psychiatric disorder
  • history of treatment for a chronic pain
  • history of nerve blocks in order to treat postoperative pain
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03857386


Locations
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Turkey
Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation
Antalya, Turkey, 07100
Sponsors and Collaborators
Antalya Training and Research Hospital
Investigators
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Principal Investigator: Arzu Karaveli Netherlands: Ministry of Health, Welfare and Sports
More Information
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Publications:

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Responsible Party: Arzu Karaveli, study director, Antalya Training and Research Hospital
ClinicalTrials.gov Identifier: NCT03857386    
Other Study ID Numbers: 10/09
First Posted: February 28, 2019    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Arzu Karaveli, Antalya Training and Research Hospital:
pectoral nerve block (PECS block)
breast reduction surgery
ultrasonography
postoperative pain
VAS score
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
 Neurologic Manifestations
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs