Comparison of Pain Therapeutic Effects After Benign Mastectomy

Condition(s) targeted: Pain, Postoperative

Intervention: Saline (Drug); Opioid (Drug); Opioid (Drug); NSAID (Drug); NSAID (Drug); Opioid (Drug); Opioid (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Nanjing Medical University

Official(s) and/or principal investigator(s):
XiaoFeng Shen, MD, Study Chair, Affiliation: Nanjing Medical University

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 can find one way to relief the postoperative pain after such operation is still unknown. We hypothesized that the pain from the relatively small surgery may not be significant compared with different treatments, even no drug was delivered to them. So then we are enrolling patients who underwent mastectomy from benign breast tumor, and observing the analgesic effects of different drugs.

Official title: Clinical Comparison of Postoperative Pain Therapeutic Effects After Benign Mastectomy

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Visual analog scale (VAS) rating of pain

Secondary outcome:

VAS rating of sedation

Overall VAS rating of satisfaction with analgesia

Incidence of side effects

Minimum age: 18 Years. Maximum age: 64 Years. Gender(s): Female.

Criteria:

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.

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

Starting date: February 2007
Ending date: December 2007
Last updated: April 18, 2008