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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: Yes ]

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

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
Genders 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  NMCH2007-241 
Study First Received: August 21, 2007
Last Updated: March 30, 2009
Health Authority: China: Ministry of Health

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

Additional relevant MeSH terms:
Pain, Postoperative
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Anti-Inflammatory Agents, Non-Steroidal
Flurbiprofen axetil
Analgesics, Non-Narcotic
Analgesics, Opioid
Anti-Inflammatory Agents
Antirheumatic Agents
Antitussive Agents
Central Nervous System Agents
Central Nervous System Depressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Narcotic Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Sensory System Agents
Therapeutic Uses processed this record on May 03, 2016