Serratus Plane Block For Breast Reduction Surgery

NCT ID: NCT02930733

Last Updated: 2017-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pain Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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ultrasound guided serratus plane block

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

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

30 ml %0,25 bupivacaine bilaterally

ultrasound guided sham block

Bilateral ultrasound guided sham block with 2 ml saline subcutaneously

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

2 ml saline subcutaneously bilaterally

Interventions

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Bupivacaine

30 ml %0,25 bupivacaine bilaterally

Intervention Type DRUG

Saline

2 ml saline subcutaneously bilaterally

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* American Society of Anesthesiologist's physiologic state I-III patients undergoing breast reduction surgery

Exclusion Criteria

* chronic pain
* bleeding disorders
* renal or hepatic insufficiency
* patients on chronic non-steroidal anti-inflammatory medications
* emergency cases
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ataturk University

OTHER

Sponsor Role lead

Responsible Party

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Ali Ahiskalioglu

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ali Ahiskalioglu

Role: PRINCIPAL_INVESTIGATOR

Ataturk University Anesthesiology and Reanimation

Locations

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Ataturk University

Erzurum, Erzurum, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 23923989 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26449303 (View on PubMed)

Other Identifiers

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AUTF ANESTHESIA3

Identifier Type: -

Identifier Source: org_study_id

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