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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04197206
Other study ID # CTB in Breast surgery
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 6, 2020
Est. completion date April 29, 2020

Study information

Verified date April 2020
Source Cigli Regional Training Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Costotransverse block is a novel regional anesthesia technique described a few months ago. It's use for breast surgery has been reported by only one case report in the literature. As the investigators have considered that Costotransverse block can be efficacious for providing postoperative analgesia in the breast surgeries, the investigators have implemented the application of this blockade into practice at the clinic. The main purpose of this study is to evaluate the analgesic effect of ultrasound-guided unilateral costotransverse block in breast cancer surgery.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date April 29, 2020
Est. primary completion date April 29, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- patients undergoing breast canser surgery under general anesthesia ASA I-II

Exclusion Criteria:

- patients undergoing breast surgery under paravertebral block and others morbidly obesity ASA III - IV infection of the skin at the site of needle puncture area patients with known allergies to any of the study drugs coagulopathy recent use of analgesic/steroid drugs

Study Design


Related Conditions & MeSH terms


Intervention

Other:
costotransverse block
patient controlled analgesia devices with tramadol

Locations

Country Name City State
Turkey Cigli regional research hospital Izmir

Sponsors (1)

Lead Sponsor Collaborator
Cigli Regional Training Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Aygun H, Thomas DT, Nart A. Ultrasound guided single injection costotransverse block in a breast conserving surgery patient; The first clinical report for novel interfascial block. J Clin Anesth. 2020 May;61:109647. doi: 10.1016/j.jclinane.2019.109647. Ep — View Citation

Nielsen MV, Moriggl B, Hoermann R, Nielsen TD, Bendtsen TF, Børglum J. Are single-injection erector spinae plane block and multiple-injection costotransverse block equivalent to thoracic paravertebral block? Acta Anaesthesiol Scand. 2019 Oct;63(9):1231-12 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 24 hours morphine consumption morphine consumptions for both group will be recorded 24 hours
Secondary Numeric rating scale for postoperative pain intensity Changes in Numeric Rating Scale (NRS) at rest and on movement will be recorded at intervals. NRS is a unidimensional measure of pain intensity in adults. The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable"). 24 hours
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