NCT03538483

Brief Summary

Serratus plane block (SPB) was first described in 2013 by Blanco and designed to primarily block the thoracic intercostal nerves. And this block provides sufficient analgesia lateral anterior and posterior part of thoracic wall.Erector Spinae Plane Block (ESPB) is a newly described and effective interfascial plane block for thoracic and abdominal surgery. It was first described by Forero et al. in 2016, effectiveness being reported in four cases. The aim of this study is to compare Serratus plane block and erector spinae plane block on postoperative pain in patients undergoing modified radical mastectomy and axillary lymph node dissection

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable postoperative-pain

Timeline
Completed

Started Dec 2017

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

Study Start

First participant enrolled

December 1, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 29, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

May 10, 2019

Status Verified

May 1, 2019

Enrollment Period

9 months

First QC Date

May 16, 2018

Last Update Submit

May 9, 2019

Conditions

Postoperative PainBreast Cancer

Outcome Measures

Primary Outcomes (1)

  • Opioid Consumption

    First 24 hours total fentanyl consumption with patient controlled analgesia

    First 24 hours

Secondary Outcomes (2)

  • Visual analog pain score

    postoperative first24 hours

  • Block Performing Time

    First hour

Study Arms (2)

ultrasound guided serratus plane block

ACTIVE COMPARATOR

Ultrasound Guided Serratus Plane Block 30 ml %0.25 Bupivacaine

Drug: Bupivacaine Hcl 0.25% Inj

ultrasound guided erector spinae plane block

ACTIVE COMPARATOR

Ultrasound Guided Erector Spinae Plane Block 20 ml %0.25 Bupivacaine

Drug: Bupivacaine HCl Inj 0.25%

Interventions

Bupivacaine Hcl 0.25% InjDRUG

30 ml %0,25 bupivacaine

ultrasound guided serratus plane block
Bupivacaine HCl Inj 0.25%DRUG

20 ml %0,25 bupivacaine

ultrasound guided erector spinae plane block

Eligibility Criteria

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

You may qualify if:

  • American Society of Anesthesiologist's physiologic state I-III patients
  • undergoing breast cancer surgery
  • years

You may not qualify if:

  • chronic pain
  • bleeding disorders
  • renal or hepatic insufficiency
  • patients on chronic non-steroidal anti-inflammatory medications
  • emergency cases
  • coagulopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University

Erzurum, 25100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, PostoperativeBreast Neoplasms

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

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

Study Record Dates

First Submitted

May 16, 2018

First Posted

May 29, 2018

Study Start

December 1, 2017

Primary Completion

September 1, 2018

Study Completion

September 30, 2018

Last Updated

May 10, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)