Efficacy of Pectoral Nerve Block for Breast Reduction Surgery

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03857386
• Other study ID #: 10/09
• Status: Completed
• Start date: July 1, 2017
• Est. completion date: May 1, 2018

Study information

• Verified date: April 2019
• Source: Antalya Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: May 1, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Surgery
• Nerve Blocks
• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• PECS group
Pecs block performed using ultrasound guidance
• Control group
Local infiltration anesthesia performed during the operation

Locations

Country	Name	City	State
Turkey	Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Antalya Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	analgesia consumption	postoperative	12 hours
Secondary	length of hospital	recorded at the following time after surgery	4 days
Secondary	analgesia consumption	intraoperative	during the surgery