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Superficial Serratus Plane Block for Modified Radical Mastectomy and Axillary Lymph Node Disection

NCT ID: NCT03341234

Last Updated: 2017-11-14

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

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-01

Study Completion Date

2017-08-01

Brief Summary

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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.

Detailed Description

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Conditions

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Postoperative Analgesia Pain, Postoperative Opioid Consumption

Keywords

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Superficial Serratus Plane Block Modified Radical Mastectomy Axillary Lymph Node Disection bupivacaine

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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Group SPB

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

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

30 ml %0,25 bupivacaine

Ultrasound

Intervention Type DEVICE

Ultrasound guided block

Group Control

Ultrasound guided sham block with 2 ml saline subcutaneously

Group Type ACTIVE_COMPARATOR

Saline

Intervention Type DRUG

2 ml saline subcutaneously

Ultrasound

Intervention Type DEVICE

Ultrasound guided block

Interventions

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Bupivacaine

30 ml %0,25 bupivacaine

Intervention Type DRUG

Saline

2 ml saline subcutaneously

Intervention Type DRUG

Ultrasound

Ultrasound guided block

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* chronic pain, bleeding disorders, renal or hepatic insufficiency,patients on chronic non-steroidal anti-inflammatory medications
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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Ahmet Murat Yayik

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Regional Training and Research Hospital

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)

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.

Reference Type BACKGROUND
PMID: 28336228 (View on PubMed)

Other Identifiers

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Superficial SPB

Identifier Type: -

Identifier Source: org_study_id