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

July 15, 2018 updated by: Yonsei University
Ultrasound guided serratus anterior plane block may decrease acute postoperative pain and consumption of opioid after mastectomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Group C
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.
Experimental: Group S
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total opioid consumption
Time Frame: within 24 hrs after mastectomy
Assessing total opioid consumption (total number of bolus injection and total dose of fentanyl via intravenous patient controlled analgesia) within 24hours after operation finished.
within 24 hrs after mastectomy

Secondary Outcome Measures

Outcome Measure
Time Frame
Postoperative pain scale (Numeric rating scale 0-10) at PACU
Time Frame: chang from 3,6,12,24 to 48hrs after operation end
chang from 3,6,12,24 to 48hrs after operation end
Total intraoperative remifentanil consumption(mcg)
Time Frame: within 24 hrs after mastectomy
within 24 hrs after mastectomy
Additional analgesics requirements (dose/number)
Time Frame: within 24 hrs after mastectomy
within 24 hrs after mastectomy
incidence and intensity of postoperative nausea and vomiting(NRS:0-10)
Time Frame: within 24 hrs after mastectomy
within 24 hrs after mastectomy
Total hospital staying time
Time Frame: within 24 hrs after mastectomy
within 24 hrs after mastectomy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 16, 2015

Primary Completion (Actual)

February 28, 2016

Study Completion (Actual)

February 28, 2016

Study Registration Dates

First Submitted

June 18, 2015

First Submitted That Met QC Criteria

June 24, 2015

First Posted (Estimate)

June 29, 2015

Study Record Updates

Last Update Posted (Actual)

July 17, 2018

Last Update Submitted That Met QC Criteria

July 15, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2015-0363

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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