Ultrasound Guided Costotransverse Block for Breast Cancer Surgery

Evaluation of Ultrasound Guided Costotransverse Block in Breast Canser Surgery Patients

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Other: costotransverse block

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • İzmir, Turkey
    • Cigli regional research hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Costotransverse block; The Costotransverse block will be administrated to this group before induction of anesthesia. An intravenous patient-controlled analgesia device within morphine will be given to the patients postoperatively.	Other: costotransverse block; patient controlled analgesia devices with tramadol; Other Names: patient controlled analgesia
No Intervention: Control Group; In this group, patients will receive only multimodal analgesic treatment including patient-controlled analgesia with morphine. No block will be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
24 hours morphine consumption	morphine consumptions for both group will be recorded	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cigli Regional Training Hospital

Publications and helpful links

General Publications

• 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. Epub 2019 Oct 26. No abstract available.
• Nielsen MV, Moriggl B, Hoermann R, Nielsen TD, Bendtsen TF, Borglum 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):1231-1238. doi: 10.1111/aas.13424. Epub 2019 Jul 23.
• Aygun H, Kiziloglu I, Ozturk NK, Ocal H, Inal A, Kutlucan L, Gonullu E, Tulgar S. Use of ultrasound guided single shot costotransverse block (intertransverse process) in breast cancer surgery: a prospective, randomized, assessor blinded, controlled clinical trial. BMC Anesthesiol. 2022 Apr 18;22(1):110. doi: 10.1186/s12871-022-01651-3.

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2020
• Primary Completion (Actual): April 29, 2020
• Study Completion (Actual): April 29, 2020

Study Registration Dates

• First Submitted: December 11, 2019
• First Submitted That Met QC Criteria: December 11, 2019
• First Posted (Actual): December 13, 2019

Study Record Updates

• Last Update Posted (Actual): April 30, 2020
• Last Update Submitted That Met QC Criteria: April 29, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: ultrasound guided block
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: CTB in Breast surgery

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No