Analgesic Effect to Postoperative Pain After Mastectomy: Ultrasound-guided Serratus Anterior Plane Block

NCT ID: NCT02483923

Last Updated: 2018-07-17

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-16

Study Completion Date

2016-02-28

Brief Summary

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Ultrasound guided serratus anterior plane block may decrease acute postoperative pain and consumption of opioid after mastectomy.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group S

Group Type EXPERIMENTAL

Ultrasound guided serratus anterior block with ropivacaine

Intervention Type DRUG

After induction of anesthesia, patients take ultrasound guided serratus anterior plane block with 0.5ml/kg of ropivacaine 0.375%. 30minutes before the end of operation, intravenous patient controlled analgesia (Basal rate 0ml/hr, 0.5mcg/kg of fentanyl, lock-out time 10minutes) is connected to patient.

Group C

Group Type PLACEBO_COMPARATOR

intravenous PCA only

Intervention Type DRUG

same dose of intravenous patient controlled analgesia (Basal rate 0ml/hr, 0.5mcg/kg of fentanyl, lock-out time 10minutes) is connected to patient only.

Interventions

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Ultrasound guided serratus anterior block with ropivacaine

After induction of anesthesia, patients take ultrasound guided serratus anterior plane block with 0.5ml/kg of ropivacaine 0.375%. 30minutes before the end of operation, intravenous patient controlled analgesia (Basal rate 0ml/hr, 0.5mcg/kg of fentanyl, lock-out time 10minutes) is connected to patient.

Intervention Type DRUG

intravenous PCA only

same dose of intravenous patient controlled analgesia (Basal rate 0ml/hr, 0.5mcg/kg of fentanyl, lock-out time 10minutes) is connected to patient only.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. ASA 1\~3
2. Age 20\~80
3. Breast cancer patient twho are scheduled for elective mastectomy

Exclusion Criteria

1. Allergy to local anesthetics or contraindication to use of ropivacaine
2. Pregnancy
3. Severe cardiovascular disease
4. Renal failure
5. Liver failure
6. Neurologic and psychologic disease
7. Chronic treatment with analgesics
8. Previous history of mastectomy or thoracic surgery.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2015-0363

Identifier Type: -

Identifier Source: org_study_id

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