Comparison of the Efficacy and Safety of NALDEBAIN With Conventional Treatment After Laparoscopic Cholecystectomy
- Registration Number
- NCT03713216
- Lead Sponsor
- Cathay General Hospital
- Brief Summary
To determine the effect and safety of NALDEBAIN versus Morphine as needed in patients after laparoscopic cholecystectomy.
- Detailed Description
This is an open-labeled, randomized clinical trial. Group A will receive one dose of NALDEBAIN before surgery. Group B will receive morphine as needed. Pain will be assessed for PACU, 4, 24, 48, 72 hours after surgery.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
Inclusion Criteria
- Male or female with 20 years old or older.
- Scheduled to electively undergo laparoscopic cholecystectomy.
- Ability and willingness to provide informed consent.
Exclusion Criteria
- Not willing to adhere to the study visit schedule and complete all study assessments.
- History of hypersensitivity or allergy to opioid, or NSAIDs or sesame oil.
- Any clinically significant condition that may interfere with study assessments or compliance.
- Pregnant or breastfeeding.
- Medical history may cause abnormal intracranial pressure.
- History of dependency, addiction, and withdrawal for narcotic drugs.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Naldebain Naldebain Subjects will receive one dose of Naldebain before surgery. Morphine Morphine Subjects will receive morphine after surgery.
- Primary Outcome Measures
Name Time Method Postoperative pain score 24 hours after surgery Using visual analog scale (VAS) with grades from 0 (no pain) to 10 (worst pain)
- Secondary Outcome Measures
Name Time Method Consumption of supplemental analgesics From Day 0 to Day 3 Sum of supplemental analgesics
Trial Locations
- Locations (1)
Cathay General Hospital
🇨🇳Taipei, Taiwan