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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04036370
Other study ID # 13/21
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 30, 2019
Est. completion date November 15, 2019

Study information

Verified date July 2019
Source Antalya Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the study is to evaluate the effect of continuous pectoral nerve block on postoperative analgesia consumption in breast cancer surgery.


Description:

Pectoral nerve 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 in breast cancer surgery.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date November 15, 2019
Est. primary completion date November 15, 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- American Society of Anesthesiology (ASA) I-II

- 18-65 years

- Body mass index (BMI) =40 kg/m2

- Elective breast cancer surgery

Exclusion Criteria:

- ASA =4

- under 18 years of age or over 65 years of age

- declining to give written informed consent

- history of allergy to the local anesthetics

- contraendications of peripheral block or local anesthetic infiltration (local infection, coagulopathy, etc)

- history of breast surgery

- treatment due to psychiatric disorder

- history of treatment for chronic pain

- history of nerve blocks in order to treat postoperative pain

Study Design


Intervention

Procedure:
PECS group
Pecs block performed using ultrasound guidance. Standard pain follow up and monitorization will be performed.
Other:
Control group
Standard pain follow up and monitorization will be performed.

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 (3)

Bashandy GM, Abbas DN. Pectoral nerves I and II blocks in multimodal analgesia for breast cancer surgery: a randomized clinical trial. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):68-74. doi: 10.1097/AAP.0000000000000163. — View Citation

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

Blanco R, Parras Maldonado T. Reply to the article entitled "Ultrasound description of Pecs II (modified Pecs I): a novel approach to breast surgery". Reply of the authors. Rev Esp Anestesiol Reanim. 2013 May;60(5):296-7. doi: 10.1016/j.redar.2013.01.002. Epub 2013 Feb 27. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary analgesia consumption postoperative 12 hours 12 hours
Secondary analgesia consumption intraoperative during the surgery
Secondary postoperative Numeric Rating Scale (NRS) score postoperative pain assessment will be performed using NRS score (NRS 0=no pain, NRS 10= most severe possible). The NRS scores will be recorded at postoperative 0, 1, 3, 6, 9, 12 hours 0, 1, 3, 6, 9, 12 hours
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