Back to resultsComparison of the Efficacy and Safety of NALDEBAIN With Conventional Treatment After Laparoscopic Cholecystectomy
Primary Purpose
Pain, Postoperative
Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Naldebain
Morphine
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative
Eligibility Criteria
Inclusion Criteria:
- Male or female with 20 years old or older.
- Scheduled to electively undergo laparoscopic cholecystectomy.
- Ability and willingness to provide informed consent.
Exclusion Criteria:
- 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.
Sites / Locations
- Cathay General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Naldebain
Morphine
Arm Description
Subjects will receive one dose of Naldebain before surgery.
Subjects will receive morphine after surgery.
Outcomes
Primary Outcome Measures
Postoperative pain score
Using visual analog scale (VAS) with grades from 0 (no pain) to 10 (worst pain)
Secondary Outcome Measures
Consumption of supplemental analgesics
Sum of supplemental analgesics
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03713216
Brief Title
Comparison of the Efficacy and Safety of NALDEBAIN With Conventional Treatment After Laparoscopic Cholecystectomy
Official Title
Comparison of the Efficacy and Safety of NALDEBAIN With Conventional Treatment After Laparoscopic Cholecystectomy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
January 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cathay General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Naldebain
Arm Type
Experimental
Arm Description
Subjects will receive one dose of Naldebain before surgery.
Arm Title
Morphine
Arm Type
Active Comparator
Arm Description
Subjects will receive morphine after surgery.
Intervention Type
Drug
Intervention Name(s)
Naldebain
Intervention Description
150 mg Nalbuphine sebacate
Intervention Type
Drug
Intervention Name(s)
Morphine
Intervention Description
Morphine
Primary Outcome Measure Information:
Title
Postoperative pain score
Description
Using visual analog scale (VAS) with grades from 0 (no pain) to 10 (worst pain)
Time Frame
24 hours after surgery
Secondary Outcome Measure Information:
Title
Consumption of supplemental analgesics
Description
Sum of supplemental analgesics
Time Frame
From Day 0 to Day 3
Other Pre-specified Outcome Measures:
Title
Incidence of adverse event
Description
Times and incidence of adverse events (injection site reaction, vomiting, nausea, dizziness)
Time Frame
From Day 0 to Day 3
Title
Percentage of Patient satisfaction
Description
Percentage of patient satisfaction by 5-grade with 'highly satisfied', 'satisfied', 'uncertain', 'dissatisfied' or 'very dissatisfied'.
Time Frame
Day 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female with 20 years old or older.
Scheduled to electively undergo laparoscopic cholecystectomy.
Ability and willingness to provide informed consent.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sing-Ong Lee, MD
Organizational Affiliation
Cathay General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cathay General Hospital
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32982387
Citation
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.
Results Reference
derived
Learn more about this trial
Comparison of the Efficacy and Safety of NALDEBAIN With Conventional Treatment After Laparoscopic Cholecystectomy
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