Skip to main content
OpenTrials
Completed

NCT Number: NCT02483923

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Allergy to local anesthetics or contraindication to use of ropivacaine
  • Pregnancy
  • Severe cardiovascular disease
  • Renal failure
  • Liver failure
  • Neurologic and psychologic disease
  • Chronic treatment with analgesics
  • Previous history of mastectomy or thoracic surgery.

Treatment and study plan

Ultrasound guided serratus anterior block with ropivacaine

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.

intravenous PCA only

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Postoperative pain scale (Numeric rating scale 0-10) at PACU

    Time frame: chang from 3,6,12,24 to 48hrs after operation end

  2. Total intraoperative remifentanil consumption(mcg)

    Time frame: within 24 hrs after mastectomy

  3. Additional analgesics requirements (dose/number)

    Time frame: within 24 hrs after mastectomy

  4. incidence and intensity of postoperative nausea and vomiting(NRS:0-10)

    Time frame: within 24 hrs after mastectomy

  5. Total hospital staying time

    Time frame: within 24 hrs after mastectomy

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 29, 2015
Registry last updated
Jul 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.