- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00519246
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
Status
Completed
Conditions
Intervention / Treatment
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:
|
Active Comparator: II
Butorphanol tartrate 1mg was given intravenously.
|
Butorphanol tartrate 1 mg i.v.
Other Names:
Butorphanol Tartrate 2 mg i.v.
Other Names:
Tramadol Hydrochloride 10 mg i.v.
Other Names:
Tramadol Hydrochloride 20 mg i.v.
Other Names:
|
Active Comparator: III
Butorphanol tartrate 2 mg was given intravenously.
|
Butorphanol tartrate 1 mg i.v.
Other Names:
Butorphanol Tartrate 2 mg i.v.
Other Names:
Tramadol Hydrochloride 10 mg i.v.
Other Names:
Tramadol Hydrochloride 20 mg i.v.
Other Names:
|
Active Comparator: IV
Flurbiprofen Axetil 50 mg was given intravenously.
|
Flurbiprofen Axetil 50 mg i.v.
Other Names:
Flurbiprofen Axetil 100 mg i.v.
Other Names:
|
Active Comparator: V
Flurbiprofen Axetil 100 mg was given intravenously.
|
Flurbiprofen Axetil 50 mg i.v.
Other Names:
Flurbiprofen Axetil 100 mg i.v.
Other Names:
|
Active Comparator: VI
Tramadol Hydrochloride 10 mg was given intravenously.
|
Butorphanol tartrate 1 mg i.v.
Other Names:
Butorphanol Tartrate 2 mg i.v.
Other Names:
Tramadol Hydrochloride 10 mg i.v.
Other Names:
Tramadol Hydrochloride 20 mg i.v.
Other Names:
|
Active Comparator: VII
Tramadol Hydrochloride 20 mg was given intravenously.
|
Butorphanol tartrate 1 mg i.v.
Other Names:
Butorphanol Tartrate 2 mg i.v.
Other Names:
Tramadol Hydrochloride 10 mg i.v.
Other Names:
Tramadol Hydrochloride 20 mg i.v.
Other Names:
|
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.
Sponsor
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
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Pain, Postoperative
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Narcotics
- Analgesics, Opioid
- Anti-Inflammatory Agents, Non-Steroidal
Other Study ID Numbers
- NMU-2579-4FW
- NMCH2007-241
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.
Clinical Trials on Pain, Postoperative
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
Ankara City Hospital BilkentRecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | SternotomyTurkey
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Thoracotomy | Postoperative Pain, Acute | Postoperative Pain, ChronicTurkey
-
Aydin Adnan Menderes UniversityCompleted
-
Aydin Adnan Menderes UniversityCompletedAcute Postoperative Pain | Chronic Postoperative PainTurkey
-
Maimonides Medical CenterCompletedPOSTOPERATIVE PAINUnited States
-
University Hospital, AntwerpUnknown
-
VA Office of Research and DevelopmentRecruitingTotal Knee Arthroplasty (Postoperative Pain) | Total Hip Arthroplasty (Postoperative Pain)United States
-
VA Office of Research and DevelopmentCompletedTotal Knee Arthroplasty (Postoperative Pain) | Total Hip Arthroplasty(Postoperative Pain)United States
Clinical Trials on Saline
-
Vanderbilt University Medical CenterActive, not recruitingPostural Tachycardia SyndromeUnited States
-
Johns Hopkins UniversityCystic Fibrosis FoundationCompletedCystic Fibrosis
-
University Hospital Inselspital, BerneCompletedCardiovascular Diseases | Valvular Heart DiseaseSwitzerland
-
Imam Abdulrahman Bin Faisal UniversityUnknownOtorhinolaryngologic Diseases | RhinosinusitisSaudi Arabia
-
Aalborg UniversityThe Danish Rheumatism AssociationCompleted
-
Qassim UniversityCompletedApical Periodontitis | Post Operative Pain | Dental Pulp NecrosesSaudi Arabia
-
Dr. Michael FlavinWithdrawn
-
Szpital im. Św. Jadwigi ŚląskiejRecruiting
-
Makassed General HospitalCompletedLength of Hospital StayLebanon
-
University of Washington, the Collaborative Health...Cystic Fibrosis FoundationCompleted