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Comparison of Pain Therapeutic Effects After Benign Mastectomy (COPTEAM)

This study has been completed.
Information provided by:
Nanjing Medical University Identifier:
First received: August 21, 2007
Last updated: March 30, 2009
Last verified: March 2009
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.

Condition Intervention Phase
Pain, Postoperative
Drug: Saline
Drug: Opioid
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Comparison of Postoperative Pain Therapeutic Effects After Benign Mastectomy

Resource links provided by NLM:

Further study details as provided by Nanjing Medical University:

Primary Outcome Measures:
  • Visual analog scale (VAS) rating of pain [ Time Frame: 0-24h after surgeries ]

Secondary Outcome Measures:
  • VAS rating of sedation [ Time Frame: 0h to 24h after the end of the operation ]
  • Overall VAS rating of satisfaction with analgesia [ Time Frame: 24 h after operation ]
  • Incidence of side effects [ Time Frame: From the initiation of analgesia (0 h) to the end of the study (24 h postoperative) ]

Enrollment: 2000
Study Start Date: February 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: I
No drug was delivered.
Drug: Saline
Saline 5 ml administrated intravenously
Other Name: Physiological solution
Active Comparator: II
Butorphanol tartrate 1mg was given intravenously.
Drug: Opioid
Butorphanol tartrate 1 mg i.v.
Other Name: NuoYang
Active Comparator: III
Butorphanol tartrate 2 mg was given intravenously.
Drug: Opioid
Butorphanol Tartrate 2 mg i.v.
Other Name: NuoYang
Active Comparator: IV
Flurbiprofen Axetil 50 mg was given intravenously.
Flurbiprofen Axetil 50 mg i.v.
Other Name: CaiFen
Active Comparator: V
Flurbiprofen Axetil 100 mg was given intravenously.
Flurbiprofen Axetil 100 mg i.v.
Other Name: CaiFen
Active Comparator: VI
Tramadol Hydrochloride 10 mg was given intravenously.
Drug: Opioid
Tramadol Hydrochloride 10 mg i.v.
Other Name: Trama
Active Comparator: VII
Tramadol Hydrochloride 20 mg was given intravenously.
Drug: Opioid
Tramadol Hydrochloride 20 mg i.v.
Other Name: Trama


Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00519246

China, Jiangsu
Nanjing Maternal and Child Care Hospital
Nanjing, Jiangsu, China, 210004
Sponsors and Collaborators
Nanjing Medical University
Study Chair: XiaoFeng Shen, MD Nanjing Medical University
  More Information

Responsible Party: XiaoFeng Shen, Nanjing Maternal and Child Health Hospital Identifier: NCT00519246     History of Changes
Other Study ID Numbers: NMU-2579-4FW
Study First Received: August 21, 2007
Last Updated: March 30, 2009

Keywords provided by Nanjing Medical University:
Breast Neoplasms
Non-Steroidal Anti-Inflammatory Agents

Additional relevant MeSH terms:
Pain, Postoperative
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Analgesics, Opioid
Flurbiprofen axetil
Anti-Inflammatory Agents, Non-Steroidal
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antitussive Agents
Respiratory System Agents
Narcotic Antagonists processed this record on May 25, 2017