Efficacy of Pectoral Nerve Block for Breast Reduction Surgery

Sponsor

Antalya Training and Research Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03857386

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

5.3

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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

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 :

Jul 1, 2017

Actual Primary Completion Date :

Mar 1, 2018

Actual Study Completion Date :

May 1, 2018

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

postoperative visual analog scale (VAS) score [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

analgesia consumption [12 hours]
postoperative
length of hospital [4 days]
recorded at the following time after surgery
analgesia consumption [during the surgery]
intraoperative

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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