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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03857386
Other study ID # 10/09
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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