NCT04197206

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable postoperative-pain

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 13, 2019

Completed
24 days until next milestone

Study Start

First participant enrolled

January 6, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2020

Completed
Last Updated

April 30, 2020

Status Verified

April 1, 2020

Enrollment Period

4 months

First QC Date

December 11, 2019

Last Update Submit

April 29, 2020

Conditions

Postoperative Pain

Keywords

ultrasound guided block

Outcome Measures

Primary Outcomes (1)

  • 24 hours morphine consumption

    morphine consumptions for both group will be recorded

    24 hours

Secondary Outcomes (1)

  • Numeric rating scale for postoperative pain intensity

    24 hours

Study Arms (2)

Costotransverse block

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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

Interventions

costotransverse blockOTHER

patient controlled analgesia devices with tramadol

Also known as: patient controlled analgesia
Costotransverse block

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cigli regional research hospital

Izmir, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 31662230RESULT

  • 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.

    PMID: 31332775RESULT

  • 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.

    PMID: 35436844DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Analgesia, Patient-Controlled

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnalgesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator,

Study Record Dates

First Submitted

December 11, 2019

First Posted

December 13, 2019

Study Start

January 6, 2020

Primary Completion

April 29, 2020

Study Completion

April 29, 2020

Last Updated

April 30, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)