Comparison of the Efficacy and Safety of NALDEBAIN With Conventional Treatment After Laparoscopic Cholecystectomy
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|ClinicalTrials.gov Identifier: NCT03713216|
Recruitment Status : Enrolling by invitation
First Posted : October 19, 2018
Last Update Posted : October 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pain, Postoperative||Drug: Naldebain Drug: Morphine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||86 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of the Efficacy and Safety of NALDEBAIN With Conventional Treatment After Laparoscopic Cholecystectomy|
|Actual Study Start Date :||July 1, 2018|
|Estimated Primary Completion Date :||March 1, 2019|
|Estimated Study Completion Date :||March 1, 2019|
Subjects will receive one dose of Naldebain before surgery.
150 mg Nalbuphine sebacate
Active Comparator: Morphine
Subjects will receive morphine after surgery.
- Postoperative pain score [ Time Frame: 24 hours after surgery ]Using visual analog scale (VAS) with grades from 0 (no pain) to 10 (worst pain)
- Consumption of supplemental analgesics [ Time Frame: From Day 0 to Day 3 ]Sum of supplemental analgesics
- Incidence of adverse event [ Time Frame: From Day 0 to Day 3 ]Times and incidence of adverse events (injection site reaction, vomiting, nausea, dizziness)
- Percentage of Patient satisfaction [ Time Frame: Day 3 ]Percentage of patient satisfaction by 5-grade with 'highly satisfied', 'satisfied', 'uncertain', 'dissatisfied' or 'very dissatisfied'.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03713216
|Cathay General Hospital|
|Principal Investigator:||Sing-Ong Lee, MD||Cathay General Hospital|