Erector Spina Plane Block vs Serratus Anterior Plane Block for Postoperative Mastectomy Pain

NCT ID: NCT04296188

Last Updated: 2020-03-12

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-18

Study Completion Date

2021-03-15

Brief Summary

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The aim of this study is to compare the efficiency of serratus anterior plane block and erector spina plane block on analgesic consumption, postoperative pain and patient's satisfaction and recovery quality in patients undergoing mastectomy.

Detailed Description

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Mastectomy may cause severe postoperative pain. There are several analgesic methods for postoperative pain management. Serratus anterior plane (SAP) block is an interfascial plane block which is performed into the fascial plane of serratus anterior muscle. It provides effective analgesia in anterior, posterior and lateral dermatomes of thorax. There are several studies about its analgesic efficacy for mastectomy pain. The erector spina plane (ESP) block is another novel plan block which provides analgesia at multi-dermatomal area of the anterior, posterior, and lateral thoracic and abdominal walls. There are some studies about its effectiveness for postoperative mastectomy pain management. However, according to our best knowledge, there is no literature comparing the efficacy of ESP block and SAP block patients undergoing mastectomy.

Conditions

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Mastectomy Pain, Postoperative Recovery Period, Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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serratus anterior plane block

The serratus anterior plane block will be performed under ultrasound guidance in the preoperative term. Tramadol will be administered via patient controlled analgesia (PCA) device at 20 mg bolus dose with 10 min. lockout time without basal infusion dose.

Group Type ACTIVE_COMPARATOR

serratus anterior plane block

Intervention Type PROCEDURE

ultrasound guided serratus anterior plane block will be done with % 0.25 bupivacaine.

erector spina plane block

The erector spina plane block will be performed under ultrasound guidance in the preoperative term. Tramadol will be administered via PCA device at 20 mg bolus dose with 10 min. lockout time without basal infusion dose.

Group Type ACTIVE_COMPARATOR

erector spina plane block

Intervention Type PROCEDURE

ultrasound guided erector spina plane block will be done with % 0.25 bupivacaine.

Interventions

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serratus anterior plane block

ultrasound guided serratus anterior plane block will be done with % 0.25 bupivacaine.

Intervention Type PROCEDURE

erector spina plane block

ultrasound guided erector spina plane block will be done with % 0.25 bupivacaine.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* American society of score anesthesiologist I-II-III
* Elective modified radical mastectomy
* 18-65 years old

Exclusion Criteria

* neurological disease
* coagulopathy disease or using anticoagulants
* non-cooperative
* allergic to one of the drugs used in the study
* recurrent breast cancer
* body mass index is above 35
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Tokat Gaziosmanpasa University

OTHER

Sponsor Role lead

Responsible Party

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Mehtap Gürler Balta

asist.prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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mehtap gürler balta, MD

Role: CONTACT

+903562129500 ext. 3494

tuğba karaman, MD

Role: CONTACT

+903562129500 ext. 3498

Other Identifiers

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19KAEK253

Identifier Type: -

Identifier Source: org_study_id

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