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COPTEAM: Comparison of Pain Therapeutic Effects After Benign Mastectomy

Sponsor
Nanjing Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT00519246
Collaborator
(none)
2,000
Enrollment
1
Location
7
Arms
10
Duration (Months)
200.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
2000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Clinical Comparison of Postoperative Pain Therapeutic Effects After Benign Mastectomy
Study Start Date :
Feb 1, 2007
Actual Primary Completion Date :
Dec 1, 2007
Actual Study Completion Date :
Dec 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: I

No drug was delivered.

Drug: Saline
Saline 5 ml administrated intravenously
Other Names:
  • Physiological solution

    		•
    Active Comparator: II

    Butorphanol tartrate 1mg was given intravenously.

    Drug: Opioid
    Butorphanol tartrate 1 mg i.v.
    Other Names:
  • NuoYang

    		•
    Active Comparator: III

    Butorphanol tartrate 2 mg was given intravenously.

    Drug: Opioid
    Butorphanol Tartrate 2 mg i.v.
    Other Names:
  • NuoYang

    		•
    Active Comparator: IV

    Flurbiprofen Axetil 50 mg was given intravenously.

    Drug: NSAID
    Flurbiprofen Axetil 50 mg i.v.
    Other Names:
  • CaiFen

    		•
    Active Comparator: V

    Flurbiprofen Axetil 100 mg was given intravenously.

    Drug: NSAID
    Flurbiprofen Axetil 100 mg i.v.
    Other Names:
  • CaiFen

    		•
    Active Comparator: VI

    Tramadol Hydrochloride 10 mg was given intravenously.

    Drug: Opioid
    Tramadol Hydrochloride 10 mg i.v.
    Other Names:
  • Trama

    		•
    Active Comparator: VII

    Tramadol Hydrochloride 20 mg was given intravenously.

    Drug: Opioid
    Tramadol Hydrochloride 20 mg i.v.
    Other Names:
  • Trama

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Visual analog scale (VAS) rating of pain [0-24h after surgeries]

    Secondary Outcome Measures

    1. VAS rating of sedation [0h to 24h after the end of the operation]

    2. Overall VAS rating of satisfaction with analgesia [24 h after operation]

    3. Incidence of side effects [From the initiation of analgesia (0 h) to the end of the study (24 h postoperative)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 64 Years
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00519246
    Other Study ID Numbers:
    • NMU-2579-4FW
    • NMCH2007-241
    First Posted:
    Aug 22, 2007
    Last Update Posted:
    Mar 31, 2009
    Last Verified:
    Mar 1, 2009
    Keywords provided by , ,
    Breast Neoplasms
    Non-Steroidal Anti-Inflammatory Agents
    Analgesia
    Additional relevant MeSH terms:
    Pain, Postoperative
    Anti-Inflammatory Agents, Non-Steroidal
    Analgesics, Opioid

    Study Results

    No Results Posted as of Mar 31, 2009