The efficacy of topical bupivacaine and triamcinolone acetonide submucosal injection for pain relief after endoscopic submucosal dissection: a randomized double-blind, placebo-controlled multi-center trial
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0002894
- Lead Sponsor
- Hallym University Medical Center-Dongtan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 86
We prospectively evaluated consecutive patients with ages of 20 or older who were scheduled to undergo ESD for pathologically diagnosed or clinically suspected gastric adenoma or cancer at Hallym medical center.
(1) declining to provide informed consent; (2) American Society of Anesthesiology risk Class 3 or higher; (3) severe hepatic disease or cardiopulmonary or renal dysfunction; (4) current analgesics including non-steroidal anti-inflammatory drug use during the preceding week; (5) allergy to bupivacaine or other amide-type local anesthesia; (6) confirmation of any other disease that could induce abdominal pain similar with post-ESD pain; (7) presence of multiple lesions requiring endoscopic resection in one patient; (8) current pregnancy or breast feeding; (9) impossible to assess pain such as severe psychiatric or neurologic disease.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the visual analogue scale
- Secondary Outcome Measures
Name Time Method the visual analogue scale;short-form McGill pain (SF-MP) score;short-form McGill pain (SF-MP) score;procedure related adverse events