Comparison of the Efficacy and Safety of NALDEBAIN With Conventional Treatment After Laparoscopic Cholecystectomy
1 other identifier
interventional
44
1 country
1
Brief Summary
To determine the effect and safety of NALDEBAIN versus Morphine as needed in patients after laparoscopic cholecystectomy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jul 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2018
CompletedFirst Submitted
Initial submission to the registry
July 16, 2018
CompletedFirst Posted
Study publicly available on registry
October 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedJuly 16, 2020
June 1, 2020
1.3 years
July 16, 2018
July 14, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Postoperative pain score
Using visual analog scale (VAS) with grades from 0 (no pain) to 10 (worst pain)
24 hours after surgery
Secondary Outcomes (1)
Consumption of supplemental analgesics
From Day 0 to Day 3
Other Outcomes (2)
Incidence of adverse event
From Day 0 to Day 3
Percentage of Patient satisfaction
Day 3
Study Arms (2)
Naldebain
EXPERIMENTALSubjects will receive one dose of Naldebain before surgery.
Morphine
ACTIVE COMPARATORSubjects will receive morphine after surgery.
Interventions
Eligibility Criteria
You may qualify if:
- Male or female with 20 years old or older.
- Scheduled to electively undergo laparoscopic cholecystectomy.
- Ability and willingness to provide informed consent.
You may not qualify if:
- Not willing to adhere to the study visit schedule and complete all study assessments.
- History of hypersensitivity or allergy to opioid, or NSAIDs or sesame oil.
- Any clinically significant condition that may interfere with study assessments or compliance.
- Pregnant or breastfeeding.
- Medical history may cause abnormal intracranial pressure.
- History of dependency, addiction, and withdrawal for narcotic drugs.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cathay General Hospital
Taipei, Taiwan
Related Publications (1)
Lee SO, Huang LP, Wong CS. Preoperative Administration of Extended-Release Dinalbuphine Sebacate Compares with Morphine for Post-Laparoscopic Cholecystectomy Pain Management: A Randomized Study. J Pain Res. 2020 Sep 9;13:2247-2253. doi: 10.2147/JPR.S263315. eCollection 2020.
PMID: 32982387DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sing-Ong Lee, MD
Cathay General Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2018
First Posted
October 19, 2018
Study Start
July 1, 2018
Primary Completion
October 1, 2019
Study Completion
January 1, 2020
Last Updated
July 16, 2020
Record last verified: 2020-06