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Ultrasound Guided Costotransverse Block for Breast Cancer Surgery

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
costotransverse block
Sponsored by
Cigli Regional Training Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring ultrasound guided block

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Cigli regional research hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Costotransverse block

Control Group

Arm Description

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.

In this group, patients will receive only multimodal analgesic treatment including patient-controlled analgesia with morphine. No block will be performed.

Outcomes

Primary Outcome Measures

24 hours morphine consumption
morphine consumptions for both group will be recorded

Secondary Outcome Measures

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").

Full Information

First Posted
December 11, 2019
Last Updated
April 29, 2020
Sponsor
Cigli Regional Training Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04197206
Brief Title
Ultrasound Guided Costotransverse Block for Breast Cancer Surgery
Official Title
Evaluation of Ultrasound Guided Costotransverse Block in Breast Canser Surgery Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
January 6, 2020 (Actual)
Primary Completion Date
April 29, 2020 (Actual)
Study Completion Date
April 29, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cigli Regional Training Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
ultrasound guided block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Costotransverse block
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
In this group, patients will receive only multimodal analgesic treatment including patient-controlled analgesia with morphine. No block will be performed.
Intervention Type
Other
Intervention Name(s)
costotransverse block
Other Intervention Name(s)
patient controlled analgesia
Intervention Description
patient controlled analgesia devices with tramadol
Primary Outcome Measure Information:
Title
24 hours morphine consumption
Description
morphine consumptions for both group will be recorded
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Numeric rating scale for postoperative pain intensity
Description
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").
Time Frame
24 hours

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Cigli regional research hospital
City
İzmir
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31662230
Citation
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.
Results Reference
result
PubMed Identifier
31332775
Citation
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.
Results Reference
result
PubMed Identifier
35436844
Citation
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.
Results Reference
derived

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Ultrasound Guided Costotransverse Block for Breast Cancer Surgery

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