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Comparison of Pain Therapeutic Effects After Benign Mastectomy (COPTEAM)

This study has been completed.
Sponsor:
Information provided by:
Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT00519246
First received: August 21, 2007
Last updated: March 30, 2009
Last verified: March 2009
History of Changes
  Purpose

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
Mastectomy
 Drug: Saline
Drug: Opioid
Drug: NSAID
 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:

U.S. FDA Resources

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.
 Drug: NSAID
Flurbiprofen Axetil 50 mg i.v.
Other Name: CaiFen
Active Comparator: V
Flurbiprofen Axetil 100 mg was given intravenously.
 Drug: NSAID
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

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00519246

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

Publications:

Responsible Party: XiaoFeng Shen, Nanjing Maternal and Child Health Hospital
ClinicalTrials.gov 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
Analgesia

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

ClinicalTrials.gov processed this record on May 16, 2013