Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Nanjing Medical University |
---|---|
Information provided by: | Nanjing Medical University |
ClinicalTrials.gov Identifier: | NCT00519246 |
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 relief the postoperative pain after such 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 |
Drug: Saline Drug: Opioid Drug: NSAID |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Clinical Comparison of Postoperative Pain Therapeutic Effects After Benign Mastectomy |
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 |
---|---|
I: Placebo Comparator
No drug was delivered.
|
Drug: Saline
Saline 5 ml administrated intravenously
|
II: Active Comparator
Butorphanol tartrate 1mg was given intravenously.
|
Drug: Opioid
Butorphanol tartrate 1 mg i.v.
|
III: Active Comparator
Butorphanol tartrate 2 mg was given intravenously.
|
Drug: Opioid
Butorphanol Tartrate 2 mg i.v.
|
IV: Active Comparator
Flurbiprofen Axetil 50 mg was given intravenously.
|
Drug: NSAID
Flurbiprofen Axetil 50 mg i.v.
|
V: Active Comparator
Flurbiprofen Axetil 100 mg was given intravenously.
|
Drug: NSAID
Flurbiprofen Axetil 100 mg i.v.
|
VI: Active Comparator
Tramadol Hydrochloride 10 mg was given intravenously.
|
Drug: Opioid
Tramadol Hydrochloride 10 mg i.v.
|
VII: Active Comparator
Tramadol Hydrochloride 20 mg was given intravenously.
|
Drug: Opioid
Tramadol Hydrochloride 20 mg i.v.
|
Ages Eligible for Study: | 18 Years to 64 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
China, Jiangsu | |
Nanjing Maternal and Child Care Hospital | |
Nanjing, Jiangsu, China, 210004 |
Study Chair: | XiaoFeng Shen, MD | Nanjing Medical University |
Responsible Party: | Nanjing Maternal and Child Health Hospital ( XiaoFeng Shen ) |
Study ID Numbers: | NMU-2579-4FW, NMCH2007-241 |
Study First Received: | August 21, 2007 |
Last Updated: | July 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00519246 |
Health Authority: | China: Ministry of Health |
Breast Neoplasms Non-Steroidal Anti-Inflammatory Agents Analgesia |
Signs and Symptoms Postoperative Complications Tramadol Flurbiprofen |
Breast Neoplasms Butorphanol Pain Pain, Postoperative |
Pathologic Processes |