Pain, PostoperativePhase 4NCT03713216
Comparison of the Efficacy and Safety of NALDEBAIN With Conventional Treatment After Laparoscopic Cholecystectomy
A Phase 4 study testing Naldebain and Morphine in people with Pain, Postoperative, run by Cathay General Hospital at 1 site in Taiwan.
Trial summary
To determine the effect and safety of NALDEBAIN versus Morphine as needed in patients after laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Naldebain and Morphine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2018to 1 Jan 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female with 20 years old or older.
- Scheduled to electively undergo laparoscopic cholecystectomy.
- Ability and willingness to provide informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
To determine the effect and safety of NALDEBAIN versus Morphine as needed in patients after laparoscopic cholecystectomy.
Read the 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.
- Conditions
- Pain, Postoperative
- Being tested
- Naldebain, Morphine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaldebainDrug
150 mg Nalbuphine sebacate
MorphineDrug
Morphine
| Study group | Role | What they receive |
|---|---|---|
| Naldebain | Experimental | Subjects will receive one dose of Naldebain before surgery. Receives: Drug: Naldebain |
| Morphine | Active comparator | Subjects will receive morphine after surgery. Receives: Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain score
Using visual analog scale (VAS) with grades from 0 (no pain) to 10 (worst pain)
Measured: 24 hours after surgery
Secondary outcomes (1)
Consumption of supplemental analgesics
Sum of supplemental analgesics
Measured: From Day 0 to Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start1 Jul 2018
- Primary completion1 Oct 2019
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cathay General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sing-Ong Lee, MD, Principal investigator, Cathay General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03713216
- Sponsor's protocol ID
- 402
- Status last verified
- Jun 2020
- First submitted
- 16 Jul 2018
- Last updated
- 16 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32982387
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy and Safety of NALDEBAIN With Conventional Treatment After Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT03713216
- Acronym / sponsor ID
- 402
- Conditions
- Pain, Postoperative
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Cathay General HospitalUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 19 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Naldebain | Experimental | Drug: NaldebainSubjects will receive one dose of Naldebain before surgery. |
| Morphine | Active comparator | Drug: MorphineSubjects will receive morphine after surgery. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female with 20 years old or older.
- Scheduled to electively undergo laparoscopic cholecystectomy.
- Ability and willingness to provide informed consent.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Naldebain150 mg Nalbuphine sebacate | Drug | Naldebain |
| MorphineMorphine | Drug | Morphine |
Primary outcome
Postoperative pain score
Time frame: 24 hours after surgery
Using visual analog scale (VAS) with grades from 0 (no pain) to 10 (worst pain)
1 secondary outcome
Consumption of supplemental analgesics
Time frame: From Day 0 to Day 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2020.
- Derived from this study: PubMed 32982387Lee 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sing-Ong Lee, MD principal investigator
Cathay General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Naldebain and Morphine in people with Pain, Postoperative, run by Cathay General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain score (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03713216, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2020.