Efficacy of Pectoral Nerve Block for Breast Reduction Surgery

NCT03857386 | Completed

• 1 other identifier: 10/09
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Nerve Blocks; Breast Surgery; Postoperative Pain

Keywords

pectoral nerve block (PECS block); breast reduction surgery; ultrasonography; postoperative pain; VAS score

Outcome Measures

Primary Outcomes (1)

• postoperative visual analog scale (VAS) score

  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.

  postoperative 0, 1, 3, 6, 9, and 12 hours

Secondary Outcomes (3)

• analgesia consumption

  12 hours

• length of hospital

  4 days

• analgesia consumption

  during the surgery

Study Arms (2)

PECS group

Preoperative bilateral PECS I + PECS II Pecs block performed by anaesthetist using ultrasound guidance in plane approach

Procedure: PECS group

Control group

Bilateral local anesthesia infiltration Local infiltration anesthesia performed by surgeon during the operation

Procedure: Control group

Interventions

PECS group PROCEDURE

Pecs block performed using ultrasound guidance

Also known as: Regional anesthesia in breast surgery

PECS group

Control group PROCEDURE

Local infiltration anesthesia performed during the operation

Also known as: Regional anesthesia in breast surgery

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Antalya Training and Research Hospital: lead

Study Sites (1)

Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation

Antalya, 07100, Turkey (Türkiye)

Location

Related Publications (1)

• Blanco R, Fajardo M, Parras Maldonado T. Ultrasound description of Pecs II (modified Pecs I): a novel approach to breast surgery. Rev Esp Anestesiol Reanim. 2012 Nov;59(9):470-5. doi: 10.1016/j.redar.2012.07.003. Epub 2012 Aug 29.

  PMID: 22939099 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Anesthesia, Conduction; Control Groups

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Arzu Karaveli

  Netherlands: Ministry of Health, Welfare and Sports

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: study director

Study Record Dates

• First Submitted: December 18, 2018
• First Posted: February 28, 2019
• Study Start: July 1, 2017
• Primary Completion: March 1, 2018
• Study Completion: May 1, 2018
• Last Updated: April 30, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)