NCT03341234

Brief Summary

Breast cancer is the most common type of cancer in women. Mastectomy and axillary lymph node disection are commonly performed as part of the cancer management. This surgery can cause significant postoperative pain. The serratus plane block (SPB) has been described for analgesia of the hemithorax and reported for many cases such as thoracoscopy, shoulder arthroscopy, breast surgery and axillary lymph node dissections. Serratus plane block may be a viable alternative to current regional anaesthetic techniques such as thoracic paravertebral and central neuraxial blockade. The aim of this study is to determine effectiveness of ultrasound guided superficial serratus plane block in patients undergoing modified radical mastectomy and axillary lymph node dissection surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2016

Shorter than P25 for not_applicable

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

November 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 14, 2017

Completed
Last Updated

November 14, 2017

Status Verified

November 1, 2017

Enrollment Period

4 months

First QC Date

November 9, 2017

Last Update Submit

November 9, 2017

Conditions

Postoperative AnalgesiaPain, PostoperativeOpioid Consumption

Keywords

Superficial Serratus Plane BlockModified Radical MastectomyAxillary Lymph Node Disectionbupivacaine

Outcome Measures

Primary Outcomes (1)

  • Opioid Consumption

    First 24 hours total fentanyl consumption with patient controlled analgesia

    First 24 hours total opioid consumption

Secondary Outcomes (6)

  • Visual analog pain score

    postoperative first hour

  • Visual analog pain score

    postoperative second hour

  • Visual analog pain score

    postoperative 4th hour

  • Visual analog pain score

    postoperative 8th hour

  • Visual analog pain score

    postoperative 12th hour

  • +1 more secondary outcomes

Study Arms (2)

Group SPB

ACTIVE COMPARATOR

Ultrasound guided serratus plane block with 30 ml %0,25 bupivacaine

Drug: BupivacaineDevice: Ultrasound

Group Control

ACTIVE COMPARATOR

Ultrasound guided sham block with 2 ml saline subcutaneously

Drug: SalineDevice: Ultrasound

Interventions

BupivacaineDRUG

30 ml %0,25 bupivacaine

Group SPB
SalineDRUG

2 ml saline subcutaneously

Group Control
UltrasoundDEVICE

Ultrasound guided block

Group ControlGroup SPB

Eligibility Criteria

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

You may qualify if:

  • American Society of Anesthesiologist's physiologic state I-III patients undergoing Modified Radical Mastectomy and Axillary Lymph Node Disection

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Regional Training and Research Hospital

Erzurum, 25070, Turkey (Türkiye)

Location

Related Publications (2)

  • Blanco R, Parras T, McDonnell JG, Prats-Galino A. Serratus plane block: a novel ultrasound-guided thoracic wall nerve block. Anaesthesia. 2013 Nov;68(11):1107-13. doi: 10.1111/anae.12344. Epub 2013 Aug 7.

    PMID: 23923989BACKGROUND

  • Ahiskalioglu A, Alici HA, Yayik AM, Celik M, Oral Ahiskalioglu E. Ultrasound guided serratus plane block for management of acute thoracic herpes zoster. Anaesth Crit Care Pain Med. 2017 Oct;36(5):323-324. doi: 10.1016/j.accpm.2017.01.008. Epub 2017 Mar 21. No abstract available.

    PMID: 28336228BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

BupivacaineSodium ChlorideUltrasonography

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

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

November 9, 2017

First Posted

November 14, 2017

Study Start

November 1, 2016

Primary Completion

March 1, 2017

Study Completion

August 1, 2017

Last Updated

November 14, 2017

Record last verified: 2017-11

Locations

TU(1)