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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03713216

Enrollment

Registered

2018-10-19

Start date

2018-07-01

Completion date

2020-01-01

Last updated

2020-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

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.

Interventions

DRUGNaldebain

150 mg Nalbuphine sebacate

DRUGMorphine

Morphine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Postoperative pain score	24 hours after surgery	Using visual analog scale (VAS) with grades from 0 (no pain) to 10 (worst pain)

Secondary

Measure	Time frame	Description
Consumption of supplemental analgesics	From Day 0 to Day 3	Sum of supplemental analgesics

Other

Measure	Time frame	Description
Incidence of adverse event	From Day 0 to Day 3	Times and incidence of adverse events (injection site reaction, vomiting, nausea, dizziness)
Percentage of Patient satisfaction	Day 3	Percentage of patient satisfaction by 5-grade with 'highly satisfied', 'satisfied', 'uncertain', 'dissatisfied' or 'very dissatisfied'.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026