Comparison of Pain Therapeutic Effects After Benign Mastectomy (COPTEAM)

March 30, 2009 updated by: Nanjing Medical University

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

2000

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Jiangsu
      • Nanjing, Jiangsu, China, 210004
        • Nanjing Maternal and Child Care Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: I
No drug was delivered.
Saline 5 ml administrated intravenously
Other Names:
  • Physiological solution
Active Comparator: II
Butorphanol tartrate 1mg was given intravenously.
Butorphanol tartrate 1 mg i.v.
Other Names:
  • NuoYang
Butorphanol Tartrate 2 mg i.v.
Other Names:
  • NuoYang
Tramadol Hydrochloride 10 mg i.v.
Other Names:
  • Trama
Tramadol Hydrochloride 20 mg i.v.
Other Names:
  • Trama
Active Comparator: III
Butorphanol tartrate 2 mg was given intravenously.
Butorphanol tartrate 1 mg i.v.
Other Names:
  • NuoYang
Butorphanol Tartrate 2 mg i.v.
Other Names:
  • NuoYang
Tramadol Hydrochloride 10 mg i.v.
Other Names:
  • Trama
Tramadol Hydrochloride 20 mg i.v.
Other Names:
  • Trama
Active Comparator: IV
Flurbiprofen Axetil 50 mg was given intravenously.
Flurbiprofen Axetil 50 mg i.v.
Other Names:
  • CaiFen
Flurbiprofen Axetil 100 mg i.v.
Other Names:
  • CaiFen
Active Comparator: V
Flurbiprofen Axetil 100 mg was given intravenously.
Flurbiprofen Axetil 50 mg i.v.
Other Names:
  • CaiFen
Flurbiprofen Axetil 100 mg i.v.
Other Names:
  • CaiFen
Active Comparator: VI
Tramadol Hydrochloride 10 mg was given intravenously.
Butorphanol tartrate 1 mg i.v.
Other Names:
  • NuoYang
Butorphanol Tartrate 2 mg i.v.
Other Names:
  • NuoYang
Tramadol Hydrochloride 10 mg i.v.
Other Names:
  • Trama
Tramadol Hydrochloride 20 mg i.v.
Other Names:
  • Trama
Active Comparator: VII
Tramadol Hydrochloride 20 mg was given intravenously.
Butorphanol tartrate 1 mg i.v.
Other Names:
  • NuoYang
Butorphanol Tartrate 2 mg i.v.
Other Names:
  • NuoYang
Tramadol Hydrochloride 10 mg i.v.
Other Names:
  • Trama
Tramadol Hydrochloride 20 mg i.v.
Other Names:
  • Trama

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Visual analog scale (VAS) rating of pain
Time Frame: 0-24h after surgeries
0-24h after surgeries

Secondary Outcome Measures

Outcome Measure
Time Frame
VAS rating of sedation
Time Frame: 0h to 24h after the end of the operation
0h to 24h after the end of the operation
Overall VAS rating of satisfaction with analgesia
Time Frame: 24 h after operation
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)
From the initiation of analgesia (0 h) to the end of the study (24 h postoperative)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

August 21, 2007

First Submitted That Met QC Criteria

August 21, 2007

First Posted (Estimate)

August 22, 2007

Study Record Updates

Last Update Posted (Estimate)

March 31, 2009

Last Update Submitted That Met QC Criteria

March 30, 2009

Last Verified

March 1, 2009

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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