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Completed

NCT Number: NCT01499836

Quality Study of Anesthetic Technique on Breast Cancer Surgery

Previous studies have shown that paravertebral block (PVB) has the potential to reduce pain and side effects after breast surgery when used in addition to general anesthesia or sedation.The investigators would like to further discern the impact of GA or PVB on the postoperative QoR, pain and satisfaction.

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Key information

Conditions

Postoperative Pain Behavior Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Personal Satisfaction Postoperative Complications Quality of Recovery Satisfaction Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Koo Foundation Sun Yat-Sen Cancer Center

Taipei, Taiwan, 11259

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient has a physical status between ASA I and III
  • Female
  • 18 - 70 years of age
  • Patients able to read a newspaper in Chinese.
  • Elective unilateral wide excision/simple mastectomy and SLNB/ALND
  • Patient has signed an informed consent
  • Without contraindication of GA or PVB
  • Body mass index (BMI) less than 24 kg/m2

Exclusion criteria

  • ASA > III
  • inability to provide informed consent
  • Bleeding disorders
  • Contraindications to nonsteroidal anti-inflammatory drugs (NSAIDs)
  • Allergy to amide-type local anesthetics or NSAIDs
  • Infection at the thoracic paravertebral injection site
  • Pregnancy or breast-feeding
  • Severe spine or chest wall deformity
  • body mass index equal to or more than 24 kg/m2
  • patients with major psychosis or drug and alcohol abuse
  • patients with a history of significant neurological, psychiatric, neuromuscular, cardiovascular, pulmonary, renal or hepatic disease
  • Patients with significant visual impairment or other physical disability that precludes complete cooperation

Treatment and study plan

PVB

Other

paravertebral block

Primary outcomes

  1. quality of recovery

    Time frame: postoperative 6 hour and postoperative day(POD)1

Secondary outcomes

  1. adverse events

    Time frame: POD1

  2. Number of patients with a technique failure of the PVB

    Time frame: during operation

  3. NRS pain score

    Time frame: postoperative 1 hour, 6 hour, and POD1

  4. Satisfaction

    Time frame: POD1

Sponsors and collaborators

Lead sponsor

Nai Liang Li

Other

Registry information

Official study title

Effect of Anesthetic Technique on Pain、 Recovery and Satisfaction in Women Undergoing Breast Surgery

Acronym: PQSAT

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 26, 2011
Registry last updated
Jan 16, 2014

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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