The analgesic efficacy and safety of nefopam in patient-controlled analgesia after breast reconstruction surgery: A randomized, double-blind, non-inferiority study
Not Applicable
- Conditions
- Neoplasms
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Female
- Target Recruitment
- 120
Inclusion Criteria
1) age over 20 and under 75 years old female patients
2) patients scheduled to undergo breast cancer resection surgery with immediate reconstruction
3) ASA physical status I-III
Exclusion Criteria
1) History of drug abuse
2) Chronic pain that requires continuous administration of opioids
3) History of seizure or mental illness
4) Bradycardia (Heart rate < 50 beats per minute) or arrhythmia
5) Cardiovascular diseases(coronary artery disease, ischemic heart disease, etc.) other than diabetes and hypertension
6) Moderate to severe renal of hepatic disease
7) Pregnant or breast feeding patients
8) History of allergy to study drugs
9) Fail to give informed consent
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method VAS (Visual Analogue Scale) pain score measured at 12-24 hours after surgery
- Secondary Outcome Measures
Name Time Method (1) VAS measured at 0-1, 1-6, 6-12, 24-48 hours after surgery (2) Total opioids dose used at 0-1, 1-6, 6-12, and 12-24 hours after surgery (3) The first rescue drug injection time from the end of surgery (4) Total infusion dose of intravenous anesthetics and opioids during the surgery (5) Vital sign during surgery (Before induction, at incision, during the surgery, end of the surgery) (6) The number of rescue drug injections during the surgery due to hypotension or bradycardia (7) Adverse event (PONV, hypotension, dyspnea, urinary retention, dizziness