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

August 21, 2007
March 30, 2009
February 2007
December 2007   (final data collection date for primary outcome measure)
Visual analog scale (VAS) rating of pain [ Time Frame: 0-24h after surgeries ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00519246 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Comparison of Pain Therapeutic Effects After Benign Mastectomy
Clinical Comparison of Postoperative 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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Pain, Postoperative
  • Mastectomy
  • Drug: Saline
    Saline 5 ml administrated intravenously
    Other Name: Physiological solution
  • Drug: Opioid
    Butorphanol tartrate 1 mg i.v.
    Other Name: NuoYang
  • Drug: Opioid
    Butorphanol Tartrate 2 mg i.v.
    Other Name: NuoYang
  • Drug: NSAID
    Flurbiprofen Axetil 50 mg i.v.
    Other Name: CaiFen
  • Drug: NSAID
    Flurbiprofen Axetil 100 mg i.v.
    Other Name: CaiFen
  • Drug: Opioid
    Tramadol Hydrochloride 10 mg i.v.
    Other Name: Trama
  • Drug: Opioid
    Tramadol Hydrochloride 20 mg i.v.
    Other Name: Trama
  • Placebo Comparator: I
    No drug was delivered.
    Intervention: Drug: Saline
  • Active Comparator: II
    Butorphanol tartrate 1mg was given intravenously.
    Intervention: Drug: Opioid
  • Active Comparator: III
    Butorphanol tartrate 2 mg was given intravenously.
    Intervention: Drug: Opioid
  • Active Comparator: IV
    Flurbiprofen Axetil 50 mg was given intravenously.
    Intervention: Drug: NSAID
  • Active Comparator: V
    Flurbiprofen Axetil 100 mg was given intravenously.
    Intervention: Drug: NSAID
  • Active Comparator: VI
    Tramadol Hydrochloride 10 mg was given intravenously.
    Intervention: Drug: Opioid
  • Active Comparator: VII
    Tramadol Hydrochloride 20 mg was given intravenously.
    Intervention: Drug: Opioid
Shen X, Wang F, Xu S, Ma L, Liu Y, Feng S, Wang W, Zhao Q, Li X, Zhao L, Yao X, Qu J, Xie B, Wang H, Yuan H, Cao Y, Sun Y, Wang W, Guo L, Song Z, Wang Z, Guan X. Comparison of the analgesic efficacy of preemptive and preventive tramadol after lumpectomy. Pharmacol Rep. 2008 May-Jun;60(3):415-21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2000
December 2007
December 2007   (final data collection date for primary outcome measure)

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.
Female
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00519246
NMU-2579-4FW, NMCH2007-241
Yes
XiaoFeng Shen, Nanjing Maternal and Child Health Hospital
Nanjing Medical University
Not Provided
Study Chair: XiaoFeng Shen, MD Nanjing Medical University
Nanjing Medical University
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP