Comparison of the Efficacy and Safety of NALDEBAIN With Conventional Treatment After Laparoscopic Cholecystectomy

Comparison of the Efficacy and Safety of NALDEBAIN With Conventional Treatment After Laparoscopic Cholecystectomy

To determine the effect and safety of NALDEBAIN versus Morphine as needed in patients after laparoscopic cholecystectomy.

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.

Inclusion Criteria:

1. Male or female with 20 years old or older.
2. Scheduled to electively undergo laparoscopic cholecystectomy.
3. Ability and willingness to provide informed consent.

Exclusion Criteria:

1. Not willing to adhere to the study visit schedule and complete all study assessments.
2. History of hypersensitivity or allergy to opioid, or NSAIDs or sesame oil.
3. Any clinically significant condition that may interfere with study assessments or compliance.
4. Pregnant or breastfeeding.
5. Medical history may cause abnormal intracranial pressure.
6. History of dependency, addiction, and withdrawal for narcotic drugs.