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Completed

NCT Number: NCT00519246

Comparison of Pain Therapeutic Effects After Benign Mastectomy

With the incremental trend of benign breast tumor, the surgical process of mastectomy was proceeded too much every day, especially in the Maternal Health Care Hospital, but whether the investigators can find another way to relieve the postoperative pain after such an operation is still unknown. The investigators hypothesized that the pain from the relatively small surgery may not be significant compared to different treatments, even if no drug was delivered to them. The investigators are enrolling patients who underwent mastectomy from benign breast tumor, and are observing the analgesic effects of different drugs.

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Key information

Conditions

Pain, Postoperative Agnosia Breast Diseases Breast Neoplasms Mastectomy Neoplasms Neoplasms by Site Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Nanjing Maternal and Child Care Hospital

Nanjing, Jiangsu, 210004, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Chinese
  • No cardiac and pulmonary diseases
  • ASA I-II
  • No alcohol drinking.

Exclusion criteria

  • <19yrs, and >65yrs
  • History of central active drugs administration
  • Drug abuse
  • Hypertension
  • Diabetes
  • Any other chronic diseases.

Treatment and study plan

Saline

Drug

Saline 5 ml administrated intravenously

Other names: Physiological solution

Opioid

Drug

Butorphanol tartrate 1 mg i.v.

Other names: NuoYang

NSAID

Drug

Flurbiprofen Axetil 50 mg i.v.

Other names: CaiFen

Primary outcomes

  1. Visual analog scale (VAS) rating of pain

    Time frame: 0-24h after surgeries

Secondary outcomes

  1. VAS rating of sedation

    Time frame: 0h to 24h after the end of the operation

  2. Overall VAS rating of satisfaction with analgesia

    Time frame: 24 h after operation

  3. Incidence of side effects

    Time frame: From the initiation of analgesia (0 h) to the end of the study (24 h postoperative)

Sponsors and collaborators

Lead sponsor

Nanjing Medical University

Other

Registry information

Official study title

Clinical Comparison of Postoperative Pain Therapeutic Effects After Benign Mastectomy

Acronym: COPTEAM

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Aug 22, 2007
Registry last updated
Mar 31, 2009

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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