Comparison of the effectiveness of local analgesic injection pump devices and local topical gel-type analgesic agents for postoperative pain control in patients undergoing bariatric metabolic surgery: A randomized controlled trial
- Conditions
- Endocrine, nutritional and metabolic diseases
- Registration Number
- KCT0009540
- Lead Sponsor
- Seoul National University Bundang Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 48
The study enrolled participants who satisfied the National Health Insurance criteria for bariatric surgery, which necessitates a body mass index (BMI) of =35 kg/m2 or a BMI of =30 kg/m2 with associated obesity-related complications such as hypertension, hyperlipidemia, diabetes, fatty liver and polycystic ovary syndrome. And individuals aged 19 years or older who voluntarily consented to participate in the study were included.
The exclusion criteria included: 1) Patients who were currently receiving, or had previously received, any investigational products, or those with medical conditions that could affect the safety and efficacy evaluation of this medical device; 2) Patients with known hypersensitivity to ropivacaine or other amide-type local anesthetics; 3) Patients experiencing severe bleeding or shock; 4) Patients with inflammation at or around the site of injection; 5) Patients suffering from sepsis; 6) Patients requiring intravenous partial anesthesia; 7) Patients who had participated in another clinical study within the past 30 days; 8) Patients considered unsuitable by the investigator for various reasons, such as lack of cooperation; and 9) Patients with contraindications to using ketorolac.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method