NCT03415646

Brief Summary

Postoperative analgesia in breast surgery is a difficult and overworked issue due to extensive surgery and complex innervation of the breast. Erector spinae plane block (ESB) is a new defined regional anesthesia technique for thoracic analgesia.Main purpose of this study was to evaluate the analgesic effect of ultrasound guided double injection ESB in breast surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at below P25 for not_applicable postoperative-pain

Timeline
Completed

Started Feb 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

January 10, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 30, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

February 3, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2018

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2018

Completed
Last Updated

March 9, 2018

Status Verified

March 1, 2018

Enrollment Period

1 month

First QC Date

January 10, 2018

Last Update Submit

March 7, 2018

Conditions

Postoperative PainBreast Cancer

Keywords

erector spinae plane blockbreast surgerypostoperative pain

Outcome Measures

Primary Outcomes (1)

  • Morphine consumption

    24 hour postoperatively

Study Arms (2)

Block Group

ACTIVE COMPARATOR

Erector Spinae Plane Block administered group

Other: Erector Spinae Plane BlockDevice: Intravenous Morphine patient controlled analgesia device

Control Group

SHAM COMPARATOR

Control group

Device: Intravenous Morphine patient controlled analgesia device

Interventions

Erector Spinae Plane BlockOTHER

erector spinae plane block with double level injection will be administered before the surgery

Block Group
Intravenous Morphine patient controlled analgesia deviceDEVICE

24 hour morphine consumption will be recorded

Block GroupControl Group

Eligibility Criteria

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

You may qualify if:

  • years of age
  • 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

İzmit, Kocaeli, 41340, Turkey (Türkiye)

Location

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
Assistant Professor

Study Record Dates

First Submitted

January 10, 2018

First Posted

January 30, 2018

Study Start

February 3, 2018

Primary Completion

March 5, 2018

Study Completion

March 7, 2018

Last Updated

March 9, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)