NCT03480958

Brief Summary

Postoperative analgesia in breast surgery is a difficult and overworked issue due to etensive surgery and complex innervation of the breast. Erector spinae plane block (ESB) is a new defined and promising regional anesthesia technique for thoracic analgesia. Main purpose of this study is to compare the analgesic effect of ultrasound guided ESB with thoracic paravertebral block - the golden standard method for postoperative regional analgesia technique in breast surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable postoperative-pain

Timeline
Completed

Started Mar 2018

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

March 18, 2018

Completed
10 days until next milestone

Study Start

First participant enrolled

March 28, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 29, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2018

Completed
Last Updated

August 28, 2018

Status Verified

August 1, 2018

Enrollment Period

5 months

First QC Date

March 18, 2018

Last Update Submit

August 27, 2018

Conditions

Postoperative PainBreast Cancer

Keywords

erector spinae plane blockthoracic paravertebral blockbreast surgerypostoperative pain

Outcome Measures

Primary Outcomes (1)

  • Morphine consumption

    All patients will be provided with IV morphine PCA and morphine consumption after 24 hour postoperatively will be recorded.

    24 hour postoperatively

Secondary Outcomes (2)

  • Numering Rating Scale scores for pain

    24 hour

  • Postoperative nausea and vomiting

    24h

Study Arms (3)

ESP group

ACTIVE COMPARATOR

Erector Spinae Plane Block administered group

Device: Intravenous morphine patient controlled deviceOther: Erector Spinae Plane Block

TPVB group

ACTIVE COMPARATOR

Thoracic Paravertebral Block administered group

Device: Intravenous morphine patient controlled deviceOther: Thoracic Paravertebral Block

Control Group

OTHER

No regional anesthesia technique will be applied to control group; but will be provided with iv PCA

Device: Intravenous morphine patient controlled device

Interventions

Intravenous morphine patient controlled deviceDEVICE

24 hour morphine consumption will be recorded

Control GroupESP groupTPVB group
Erector Spinae Plane BlockOTHER

erector spinae plane block will be administered before the surgery

ESP group
Thoracic Paravertebral BlockOTHER

thoracic paravertebral block will be administered before the surgery

TPVB group

Eligibility Criteria

Age25 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of agge
  • ASA I-II
  • Undergoing elective breast cancer surgery

You may not qualify if:

  • obesity (body mass index \>35 kg/m2)
  • 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 drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University Hospital

Kocaeli, 41340, Turkey (Türkiye)

Location

Related Publications (1)

  • Gurkan Y, Aksu C, Kus A, Yorukoglu UH. Erector spinae plane block and thoracic paravertebral block for breast surgery compared to IV-morphine: A randomized controlled trial. J Clin Anesth. 2020 Feb;59:84-88. doi: 10.1016/j.jclinane.2019.06.036. Epub 2019 Jul 4.

    PMID: 31280100DERIVED

MeSH Terms

Conditions

Pain, PostoperativeBreast Neoplasms

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 18, 2018

First Posted

March 29, 2018

Study Start

March 28, 2018

Primary Completion

August 20, 2018

Study Completion

August 20, 2018

Last Updated

August 28, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)