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

Cathay General Hospital

Status and phase: Completed; Phase 4

Conditions: Pain, Postoperative

Treatments: Drug: Naldebain; Drug: Morphine

Study type: Interventional

Funder types: Other

Identifiers

NCT03713216

402

Details and patient eligibility

About

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

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Naldebain

Experimental group

Description:

Subjects will receive one dose of Naldebain before surgery.

Treatment:

Drug: Naldebain

Morphine

Active Comparator group

Description:

Subjects will receive morphine after surgery.

Treatment:

Drug: Morphine