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Completed

NCT Number: NCT02747992

Paravertebral Block (PVB) Combined Pectoral Musculature Blocks for Modified Radical Mastectomy (MRM)

Previous studies have shown that PVB reduces pain and postoperative nausea and vomiting after breast cancer surgery when used in addition to general anesthesia or sedation. However, major breast cancer surgery involves areas beyond the breast tissue, such as pectoral musculature.

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Key information

Conditions

Mastectomy, Modified Radical

Age range

20 year–75 year

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The American Society of Anesthesiologists (ASA) Physical Status classification I to III
  • 20 - 75 years of age
  • female gender

Exclusion criteria

  • body mass index (BMI) ≥ 35 kg/m2
  • modified radical mastectomy not performed by the single surgeon (Ben Long Yu)
  • anesthesia not performed by the single anesthesiologist (Nai Liang Li)

Treatment and study plan

Primary outcomes

  1. intraoperative sedation requirement

    Time frame: during operation

    target controlled infusion (TCI) propofol driven by the Schnider model in effect site control titrated to reach conscious sedation defined as Observer Assessment of Alertness/Sedation score of 2 to 3

Secondary outcomes

  1. time to first request of analgesics

    Time frame: postoperative 12 hours

  2. postoperative analgesic requirement

    Time frame: postoperation to discharge

  3. side effects

    Time frame: postoperation to within 24 hours after discharge

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

Comparisons the Analgesia of Paravertebral Block Combined With Thoracic Wall Block Versus Paravertebral Block Alone for Modified Radical Mastectomy in Breast Cancer

Important dates

Study start
2015
Primary completion
2016
First posted
Apr 22, 2016
Registry last updated
Apr 22, 2016

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.

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