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

Cathay General Hospital44 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pain, Postoperative

Interventions

NaldebainDRUG

150 mg Nalbuphine sebacate

MorphineDRUG

Morphine

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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.

Locations (1)

Cathay General Hospital

Taipei, Taiwan

Outcomes

Primary Outcomes

Postoperative pain score

Using visual analog scale (VAS) with grades from 0 (no pain) to 10 (worst pain)

Time frame: 24 hours after surgery

Secondary Outcomes

Consumption of supplemental analgesics

Sum of supplemental analgesics

Time frame: From Day 0 to Day 3

Data from ClinicalTrials.gov

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