Mastectomy, Pain, Postoperative
Conditions
Keywords
Breast Neoplasms, Non-Steroidal Anti-Inflammatory Agents, Analgesia
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.
Interventions
DRUGSaline
Saline 5 ml administrated intravenously
DRUGOpioid
Butorphanol tartrate 1 mg i.v.
DRUGNSAID
Flurbiprofen Axetil 50 mg i.v.
Sponsors
Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 64 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual analog scale (VAS) rating of pain | 0-24h after surgeries |
Secondary
| Measure | Time frame |
|---|---|
| VAS rating of sedation | 0h to 24h after the end of the operation |
| Overall VAS rating of satisfaction with analgesia | 24 h after operation |
| Incidence of side effects | From the initiation of analgesia (0 h) to the end of the study (24 h postoperative) |
Countries
China
Outcome results
None listed