NCT02930733

Brief Summary

Serratus plane block 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.Increased use of ultrasound guidance for regional anesthesia in recent years has led to definition of thoracic wall PECs blocks by Blanco. The Serratus plain block (SPB), providing wider analgesia, with easier application and less adverse effects than neuroaxial blocks, has been defined after these blocks and has taken its place in the literature.In spite of the insufficient randomized clinical trials in the literature, SPB has been reported for many cases such as thoracoscopy, shoulder arthroscopy, breast surgery and axillary lymph node dissections, and the results are promising. The aim of this study is to determine effectiveness of ultrasound guided bilateral serratus plane block in patients undergoing breast reduction surgery. Main outcome measures: The primary endpoint is postoperative opioid consumption. Secondary endpoints are visual analogue pain scores, opioid related side effects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2016

Shorter than P25 for phase_4

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

July 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 12, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 24, 2017

Status Verified

January 1, 2017

Enrollment Period

5 months

First QC Date

October 10, 2016

Last Update Submit

January 21, 2017

Conditions

Pain Management

Keywords

Postoperative AnalgesiaUltrasound guided serratus plane block

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 8thhour

  • Visual analog pain score

    postoperative 12th hour

  • +1 more secondary outcomes

Study Arms (2)

ultrasound guided serratus plane block

ACTIVE COMPARATOR

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

Drug: Bupivacaine

ultrasound guided sham block

PLACEBO COMPARATOR

Bilateral ultrasound guided sham block with 2 ml saline subcutaneously

Drug: Saline

Interventions

BupivacaineDRUG

30 ml %0,25 bupivacaine bilaterally

ultrasound guided serratus plane block
SalineDRUG

2 ml saline subcutaneously bilaterally

ultrasound guided sham block

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 breast reduction surgery

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University

Erzurum, Erzurum, 25100, 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

  • Broseta AM, Errando C, De Andres J, Diaz-Cambronero O, Ortega-Monzo J. Serratus plane block: the regional analgesia technique for thoracoscopy? Anaesthesia. 2015 Nov;70(11):1329-30. doi: 10.1111/anae.13263. No abstract available.

    PMID: 26449303BACKGROUND

MeSH Terms

Conditions

Agnosia

Interventions

BupivacaineSodium Chloride

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Ali Ahiskalioglu

    Ataturk University Anesthesiology and Reanimation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 10, 2016

First Posted

October 12, 2016

Study Start

July 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

January 24, 2017

Record last verified: 2017-01

Locations

TU(1)