NCT03509090

Brief Summary

Erector spinae plane block (ESPB) is a recently described block. Although there is still no consensus of its mechanism, the published case series seems to promise a new regional anesthesia technique for both chronic and acute pain. In this clinical trial, the postoperative analgesic effect of ESPB will be studied in patients underwent unilateral breast cancer surgery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

April 3, 2018

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

April 16, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 26, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

March 11, 2019

Status Verified

March 1, 2019

Enrollment Period

1.1 years

First QC Date

April 16, 2018

Last Update Submit

March 8, 2019

Conditions

Breast Cancer

Keywords

regional anesthesiaerector spinae plane blockpostoperative pain

Outcome Measures

Primary Outcomes (1)

  • postoperative anaglesic effect of ESPB in unilateral segmental mastectomy patients

    Post operative pain scores will be recorded with NRS and opioid usage will be recorded

    24 hours postoperatively

Study Arms (2)

ESP block group

ACTIVE COMPARATOR

Unilateral ESP block will be applied as postoperative regional analgesia technique in addition to the multimodal therapy. Then she is positioned in a right lateral position to perform ESP blocks. The skin will be disinfected and ESP block at one side will be performed in the lateral decubitus position and at T4 transverse process level by using 10-MHz linear ultrasound probe (Logic Ebook XP General Electrics, USA). The probe will be located 3 cm lateral to T4 spinous process in longitudinal parasagittal orientation. An 8 cm 21 gauge needle (BRAUN Stimuplex A®, Germany) will be inserted by using out of the plane technique. The ESP blocks proceed with 15 ml of 0,25% bupivacaine, 7,5 ml 1 % lidocaine, ,7,5 ml 0,9 % NaCl as total 30 ml . The injections will be applied after the confirmation of location by hidrodisection developed anterior to erector spinae muscle with 1-2 ml of local anesthetic solution.

Procedure: erector spinae block

Control group

ACTIVE COMPARATOR

In this group, patients will receive only multimodal analgesic treatment including patient-controlled analgesia prepared with tramadol. Patient-controlled analgesia (PCA) with tramadol at 3mg/cc concentration is programmed with no basal infusion, demand dose 10 mg and 20-minute lock-out interval. Also, patients received 1 gr paracetamol in every 6 hours.

Procedure: Control group

Interventions

erector spinae blockPROCEDURE

erector spinae block will be performed in this group as postoperative analgesia treatment.

ESP block group
Control groupPROCEDURE

patients will receive only multimodal analgesic treatment including patient-controlled analgesia

Control group

Eligibility Criteria

Age18 Years - 90 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being volunteer
  • Over 18 years old
  • Unilateral segmental mastectomy patients

You may not qualify if:

  • Emergency operations
  • Younger than 18 years old,
  • Non Volunteers
  • ASA 3 and 4 patients
  • Non-cooperative patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maltepe University Medical Faculty

Istanbul, 34843, Turkey (Türkiye)

RECRUITING

Related Publications (2)

  • Chin KJ, Adhikary S, Sarwani N, Forero M. The analgesic efficacy of pre-operative bilateral erector spinae plane (ESP) blocks in patients having ventral hernia repair. Anaesthesia. 2017 Apr;72(4):452-460. doi: 10.1111/anae.13814. Epub 2017 Feb 11.

    PMID: 28188621BACKGROUND

  • Bonvicini D, Giacomazzi A, Pizzirani E. Use of the ultrasound-guided erector spinae plane block in breast surgery. Minerva Anestesiol. 2017 Oct;83(10):1111-1112. doi: 10.23736/S0375-9393.17.12015-8. Epub 2017 May 11. No abstract available.

    PMID: 28492298RESULT

MeSH Terms

Conditions

Breast NeoplasmsPain, Postoperative

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Central Study Contacts

Onur Selvi, Dr

CONTACT

02164440620prostel@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 16, 2018

First Posted

April 26, 2018

Study Start

April 3, 2018

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

March 11, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)