Efficacy of Pectoral Nerve Block for Breast Reduction Surgery

Comparison of The Effects of Pectoral Nerve Block and Local Infiltration Anesthesia on Postoperative Analgesia for Breast Reduction Surgery

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.

Study Overview

• Status: Completed
• Conditions: Breast Surgery; Postoperative Pain; Nerve Blocks
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 53

Contacts and Locations

Study Locations

• Turkey
  • Antalya, Turkey, 07100
    • Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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 Names: 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 Names: Regional anesthesia in breast surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
analgesia consumption	intraoperative	during the surgery
analgesia consumption	postoperative	12 hours
length of hospital	recorded at the following time after surgery	4 days

Collaborators and Investigators

• Sponsor: Antalya Training and Research Hospital
• Investigators: Principal Investigator: Arzu Karaveli, Netherlands: Ministry of Health, Welfare and Sports

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: December 18, 2018
• First Submitted That Met QC Criteria: February 26, 2019
• First Posted (Actual): February 28, 2019

Study Record Updates

• Last Update Posted (Actual): April 30, 2019
• Last Update Submitted That Met QC Criteria: April 26, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: postoperative pain; ultrasonography; VAS score; breast reduction surgery; pectoral nerve block (PECS block)
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 10/09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No