Postoperative PainPhase 4NCT03854851
NALDEBAIN for Postoperative Pain Management in Take Down of Anastomosis
A Phase 4 study testing Naldebain and Morpine in people with Postoperative Pain, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
NALDEBAIN ER injection, invented by Taiwanese, launched in 2017, is a nalbuphine synthetic prodrug with oil-based solution to extend the release in human body by intramuscular injection. It was approved for the premedication use for moderate to severe pain relief, expected after surgery. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Naldebain and Morpine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2019to 31 Oct 2019
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and Women between 20 and 80 years of age
- History of laparoscopic surgery
- American Society of Anesthesiology Physical Class 1-3
- Ability and willingness to provide informed consent
Who cannot join
- History of hypersensitivity or allergy to opioid, NSAIDs, or Acetaminophen
- Chronic preoperative opioid use
- Severe comorbidity which is able to interfere pain assessment
- Ostomy surgery of intestine within the past 8 weeks
- Pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University & Hospital
Taichung, 404
Hung-Chang Chen, 04-22052121 ext. 81-221071, D96591@mail.cmuh.org.tw
Hung-Chang Chen
About this study
NALDEBAIN ER injection, invented by Taiwanese, launched in 2017, is a nalbuphine synthetic prodrug with oil-based solution to extend the release in human body by intramuscular injection. It was approved for the premedication use for moderate to severe pain relief, expected after surgery. There was limited experience with the combination of medication and different type of surgeries. Only the effect of operative analgesia on the hemorrhoidectomy patients have been well studied. Through reviewing the past medical cases, the pain intensity after receiving take down of anastomosis was about 4 to 7 points (moderate pain), lasing about 1 to 3 days. It was a suitable population with multi-day analgesic unmet need.
At present, the standard treatment after take down of anastomosis in the CMUH was morphine as needed. This treatment might not provide for well-controlled postoperative pain management. Patients might receive more painkillers when they needed than before pain occurred. Plus, it also cost more postoperative medical care. Therefore, this study intended to compare the standard treatment and NALDEBAIN for postoperative outcomes, safety and satisfaction.
The study will enroll patients scheduled to electively undergo take down of anastomosis. Eligible subjects were randomly divided into two groups, one receiving NALDEBAIN and the other receiving standard treatment. The study will evaluate pain intensity, dosage of supplement analgesics, incidence of adverse reactions, patient satisfaction, time of the first fart after surgery, and duration of postoperative hospital stay.
Read the detailed description
This is an open-labeled, randomized clinical trial. After ICFs are signed, patients' medical history will be gained for checking if they are eligible for this study or not. And then, on Day -1, eligible ones will randomly be divide into two separate group: NALDEBAIN or MORPHINE. Group NALDEBAIN will receive Nadebain by gluteus maximus injection between 12 and 24 hours prior to surgery for postoperative pain relief. Group MORPHINE will receive morphine as needed after surgery. All necessary data will be gain form EMR or patient dairies.
- Conditions
- Postoperative Pain
- Being tested
- Naldebain, Morpine
- Keywords
- Naldebain, long-term analgesia, take down of anastomosis
- 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
In Naldebain group, patients will be injected with Naldebain (150 mg/2 ml, IM injection) between 12 and 24 hours prior to surgery.
MorpineDrug
In Morphine group, patients will receive morphine as needed after surgery.
| Study group | Role | What they receive |
|---|---|---|
| NALDEBAIN | Experimental | In group NALDEBAIN, subjects will receive single dose of Naldebain (150 mg/2 ml) by gluteus maximus injection between 12 and 24 hours prior to surgery. Receives: Drug: Naldebain |
| MORPHINE | Active comparator | In group MORPHINE, subjects will receive morphine as needed after surgery. Receives: Drug: Morpine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Supplemental analgesics
The consumption of total amount (mg) of supplemental analgesics administered after surgery.
Measured: From Day 0 to Day 7
Secondary outcomes (7)
Pain assessment: VAS
Using visual analog scale (VAS) with grades from 0 (no pain) to 10 (worst pain)
Measured: 2 hours after surgery
Pain assessment: VAS
Using visual analog scale (VAS) with grades from 0 (no pain) to 10 (worst pain)
Measured: 6 hours after surgery
Pain assessment: VAS
Using visual analog scale (VAS) with grades from 0 (no pain) to 10 (worst pain)
Measured: 24 hours after surgery
Pain assessment: VAS
Using visual analog scale (VAS) with grades from 0 (no pain) to 10 (worst pain), once daily
Measured: From Day 2 to Day 7
Pain assessment: area under the curve of VAS
Pain assessment (time-specific pain intensity) calculated as the area under the curve of VAS pain intensity scores through 7 days after surgery
Measured: From post-OP to Day 7
Patient satisfaction: frequency of each option
Calculating the frequency of each option: highly satisfied, satisfied, uncertain, dissatisfied and very dissatisfied
Measured: Day 7
frequency of adverse event
Recording the frequency of treatment-emergent adverse event (TEAE)
Measured: From Day-1 to Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start1 Mar 2019 (estimated)
- Primary completion31 Jul 2019 (estimated)
- Study completion31 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hung-Chang Chen, China Medical University Hospital
- Investigators
- Hung-Chang Chen, MD, Principal investigator, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03854851
- Sponsor's protocol ID
- CMUH107-REC2-110
- Status last verified
- Feb 2019
- First submitted
- 20 Feb 2019
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NALDEBAIN for Postoperative Pain Management in Take Down of Anastomosis
- ClinicalTrials.gov ID
- NCT03854851
- Acronym / sponsor ID
- CMUH107-REC2-110
- Conditions
- Postoperative Pain
- Keywords
- Naldebain, long-term analgesia, take down of anastomosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2019 (estimated)
- Primary completion
- 31 Jul 2019 (estimated)
- Study completion
- 31 Oct 2019 (estimated)
- First posted
- 26 Feb 2019 (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.
NALDEBAIN ER injection, invented by Taiwanese, launched in 2017, is a nalbuphine synthetic prodrug with oil-based solution to extend the release in human body by intramuscular injection. It was approved for the premedication use for moderate to severe pain relief, expected after surgery. There was limited experience with the combination of medication and different type of surgeries. Only the effect of operative analgesia on the hemorrhoidectomy patients have been well studied. Through reviewing the past medical cases, the pain intensity after receiving take down of anastomosis was about 4 to 7 points (moderate pain), lasing about 1 to 3 days. It was a suitable population with multi-day analgesic unmet need.
At present, the standard treatment after take down of anastomosis in the CMUH was morphine as needed. This treatment might not provide for well-controlled postoperative pain management. Patients might receive more painkillers when they needed than before pain occurred. Plus, it also cost more postoperative medical care. Therefore, this study intended to compare the standard treatment and NALDEBAIN for postoperative outcomes, safety and satisfaction.
The study will enroll patients scheduled to electively undergo take down of anastomosis. Eligible subjects were randomly divided into two groups, one receiving NALDEBAIN and the other receiving standard treatment. The study will evaluate pain intensity, dosage of supplement analgesics, incidence of adverse reactions, patient satisfaction, time of the first fart after surgery, and duration of postoperative hospital stay.
Detailed description
This is an open-labeled, randomized clinical trial. After ICFs are signed, patients' medical history will be gained for checking if they are eligible for this study or not. And then, on Day -1, eligible ones will randomly be divide into two separate group: NALDEBAIN or MORPHINE. Group NALDEBAIN will receive Nadebain by gluteus maximus injection between 12 and 24 hours prior to surgery for postoperative pain relief. Group MORPHINE will receive morphine as needed after surgery. All necessary data will be gain form EMR or patient dairies.
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: NaldebainIn group NALDEBAIN, subjects will receive single dose of Naldebain (150 mg/2 ml) by gluteus maximus injection between 12 and 24 hours prior to surgery. |
| MORPHINE | Active comparator | Drug: MorpineIn group MORPHINE, subjects will receive morphine as needed after surgery. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and Women between 20 and 80 years of age
- History of laparoscopic surgery
- American Society of Anesthesiology Physical Class 1-3
- Ability and willingness to provide informed consent
Key exclusion criteria (5 listed)
- History of hypersensitivity or allergy to opioid, NSAIDs, or Acetaminophen
- Chronic preoperative opioid use
- Severe comorbidity which is able to interfere pain assessment
- Ostomy surgery of intestine within the past 8 weeks
- Pregnant or breastfeeding
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 |
|---|---|---|
| NaldebainIn Naldebain group, patients will be injected with Naldebain (150 mg/2 ml, IM injection) between 12 and 24 hours prior to surgery. | Drug | NALDEBAIN |
| MorpineIn Morphine group, patients will receive morphine as needed after surgery. | Drug | MORPHINE |
Primary outcome
Supplemental analgesics
Time frame: From Day 0 to Day 7
The consumption of total amount (mg) of supplemental analgesics administered after surgery.
7 secondary outcomes
Pain assessment: VAS
Time frame: 2 hours after surgery
Pain assessment: VAS
Time frame: 6 hours after surgery
Pain assessment: VAS
Time frame: 24 hours after surgery
Pain assessment: VAS
Time frame: From Day 2 to Day 7
Pain assessment: area under the curve of VAS
Time frame: From post-OP to Day 7
Patient satisfaction: frequency of each option
Time frame: Day 7
frequency of adverse event
Time frame: From Day-1 to Day 7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Individual participant dataSharing planned: No
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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.
Hung-Chang Chen, MD principal investigator
China Medical University 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 Morpine in people with Postoperative Pain, run by China Medical University 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 26 Feb 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hung-Chang Chen (04-22052121 ext. 81-221071, D96591@mail.cmuh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Supplemental analgesics (time frame: From Day 0 to Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Feb 2019.