Pain, PostoperativePhase 4NCT03296488
The Efficacy and Safety of NALDEBAIN for the Treatment of Post-Laparotomy Surgery
A Phase 4 study testing Nalbuphine Sebacate and Fentanyl Citrate in people with Pain, Postoperative, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
The primary objective of this study is to determine the safety and efficacy of single doses of intramuscular NALDEBAIN on patients scheduled to undergo elective laparotomy. This will be performed by administering NALDEBAIN pre-operatively to subjects scheduled to undergo elective laparotomy, and assessing the safety… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Nalbuphine Sebacate and Fentanyl Citrate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 Aug 2017to 31 Dec 2018
- 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
- Male or female who is among 20 to 80 years of age at screening.
- Scheduled to electively undergo open-laparotomy.
- American Society of Anesthesiology Physical Class 1-3.
- Ability and willingness to provide informed consent
Who cannot join
- Body mass index less than 18 kg/m2 or greater than 30 kg/m2.
- History of previous open-laparotomy.
- Surgery with major complication, or need blood transfusion.
- History of hypersensitivity or adverse reaction to local anesthetics, opioid, or any ingredient of the medications administered in this study.
- Severe comorbidity.
- Chronic preoperative opioid consumption.
- Pregnant or breastfeeding.
- Inability to use the PCA device.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chung-Ho Memorial Hospital, Kaohsiung Medical University:
Kaohsiung City, 807
Jaw-Yuan Wang, PhD, +886-7-3121101 ext. 5575, cy614112@ms14.hinet.net
Tsung-Kun Chang, MD, +886-7-3121101 ext. 5575, tsungkunchang@gmail.com
About this study
Official title: A Randomized Controlled Trial to Compare the Efficacy and Safety of NALDEBAIN With Intravenous Patient-Controlled Analgesia With Fentanyl for the Treatment of Post-Laparotomy Surgery
The primary objective of this study is to determine the safety and efficacy of single doses of intramuscular NALDEBAIN on patients scheduled to undergo elective laparotomy. This will be performed by administering NALDEBAIN pre-operatively to subjects scheduled to undergo elective laparotomy, and assessing the safety and efficacy of the drug compared to PCA with fentanyl. The study will demonstrate whether single use of NALDEBAIN is noninferior to PCA with fentanyl or not.
Read the detailed description
Screening (Days -30 to -1) (All Study Subjects)
The nature of the study, as well as the potential risks and benefits associated with study participation, will be fully explained to all potential subjects. The following will then be obtained:
- Informed consent.
- Demographic information, including sex, age, BMI and type of surgery.
- Vital signs, including temperature, respiratory rate, blood pressure and heart rate.
- Medical history, including medication use and history of allergy.
- Physical examination.
- Laboratory testing, including hematological and biochemical tests, and urinalysis.
- ECG and X-ray.
Study Day -1 (All Eligible Subjects)
- Eligible subjects will be required to check into the clinical site before surgery (Day -1). The following procedures will be performed upon check-in:
- Review inclusion/exclusion criteria
- Randomization
- Review of concomitant medications
- Review of adverse events
- Additional laboratory tests will be requested as needed deciding by the investigator.
- All eligible subjects will hospitalize and be randomized into one of two treatment groups:
- Group 1 - Intramuscular NALDEBAIN.
- Group 2 - Intravenous PCA with fentanyl. Group 1 will receive single dose of NALDEBAIN (150 mg Nalbuphine Sebacate) intramuscularly 24±12 hours before surgery.
Group 2 will receive intravenous patient-controlled analgesia with fentanyl through 48 hours after surgery.
- Pain assessment: group 1 and 2 will rate their pain intensity using a VAS pain scale prior dosing or at Day -1 respectively.
- Brief Pain Inventory (BPI) will be evaluated at Day -1.
- Vital signs will be checked prior to dosing and once daily before Day 6.
- Group 1 received NALDEBAIN will evaluate injection site within 1 hour prior to dosing.
Study Day 0-5 All subjects will be given general anesthesia prior to their scheduled surgical procedure.
If patients need additional medication for treatment of pain, Ketorolac and Morphine could be used as supplemental analgesics when they needed.
After surgery, the following evaluations will be performed:
- Pain assessment: All subjects will rate their average pain intensity using a VAS pain scale. The assessment will perform before the first use of PCA or supplemental analgesics and at 4±1, 24±2, 32±3, 48±4 hours and once daily on Days 3 to Day 5 after the surgery.
- Brief Pain Inventory (BPI) will be evaluated at Day 2.
- Vital signs (temperature, respiratory rate, blood pressure and heart rate) will be checked once daily before Day 6.
- In Group 1 (NALDEBAIN group), the injection site will be evaluated once daily before final visit.
- Review of concomitant medication and adverse event record.
- In Group 2 (PCA group), the amount of fentanyl used will be recorded on Days 0 through 2.
Study Day 6 Evaluate the following items at Day 6.
- Pain assessment: Subjects will rate their pain intensity in the patient diary.
- Brief Pain Inventory (BPI) will be evaluated.
- Vital signs (temperature, respiratory rate, blood pressure and heart rate) will be checked.
- Injection site evaluation.
- Review of the adverse event record.
- Review of concomitant medication. Final Visit (Day of Discharge, Day 6~30)
- Vital signs (temperature, respiratory rate, blood pressure and heart rate) will be checked
- Injection site evaluation
- Laboratory tests, including hematological and biochemical tests, and urinalysis.
- Patient satisfaction: At the final visit, each subject was asked the following question: "How satisfied were you with your postsurgical analgesia"? Subjects were asked to classify themselves as either "highly satisfied", "satisfied", "uncertain", "dissatisfied", or "very dissatisfied".
- Physical examination.
- Review of the adverse event record.
- Review of concomitant medication.
- Conditions
- Pain, Postoperative
- Being tested
- Nalbuphine Sebacate, Fentanyl Citrate
- Keywords
- post-laparotomy wound pain, NALDEBAIN (150 mg Nalbuphine Sebacate), PCA (patient-control-ed alagesia)
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nalbuphine SebacateDrug
Also called NALDEBAIN
intramuscular single dose of NALDEBAIN 24±12 hours before surgery.
Fentanyl CitrateDrug
Also called PCA with fentanyl
Intravenous patient-controlled analgesia with fentanyl through 48 hours after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Nalbuphine Sebacate | Experimental | receive single dose of NALDEBAIN (150 mg Nalbuphine Sebacate, 75 mg/ml, 2 ml/vial) intramuscularly 24±12 hours before surgery. Receives: Drug: Nalbuphine Sebacate |
| Fentanyl Citrate | Active comparator | receive intravenous patient-controlled analgesia with fentanyl through 48 hours after surgery. Receives: Drug: Fentanyl Citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain assessment (post-OP 48 hours)
Pain assessment (time-specific pain intensity) calculated as the area under the curve of VAS pain intensity scores through 48 hours after surgery.
Measured: During post-OP 48 hours
Secondary outcomes (5)
supplemental analgesics
The consumption of total amount (mg) of supplemental analgesics administered after surgery.
Measured: From post-OP to Day 6
Pain assessment (post-OP to Day 6)
Pain assessment calculated as the area under the curve of VAS pain intensity scores through end of surgery to Day 6
Measured: From post-OP to Day 6
Brief Pain Inventory
Pain intensity and interference of Brief Pain Inventory (BPI)
Measured: pre-OP Day -1, post-OP Day 2 and Day 6
Patient satisfaction
Patient satisfaction on a 5-point rating.
Measured: On discharge Day, between post-OP Day 7 and Day 14
Length of postoperative hospital stay
Length of postoperative hospital stay.
Measured: From post-OP to Discharge Day, about 1 to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2017
- Study start17 Aug 2017
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial 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
- 110 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaw-Yuan Wang, MD, PhD, Kaohsiung Medical University Chung-Ho Memorial Hospital
- Investigators
- Jaw-Yuan Wang, PhD, Study chair, Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03296488
- Sponsor's protocol ID
- KMUHIRB-F(I)-20170089
- Status last verified
- Sep 2017
- First submitted
- 19 Sep 2017
- Last updated
- 28 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chang TK, Huang CW, Su WC, Tsai HL, Ma CJ, Yeh YS, Chen YC, Li CC, Cheng KI, Su MP, Wang JY. Extended-Release Dinalbuphine Sebacate Versus Intravenous Patient-Controlled Analgesia with Fentanyl for Postoperative Moderate-to-Severe Pain: A Randomized Controlled Trial. Pain Ther. 2020 Dec;9(2):671-681. doi: 10.1007/s40122-020-00197-x. Epub 2020 Sep 29.
PubMed 32990938Tsai HL, Chang TK, Su WC, Yeh YS, Huang CW, Ma CJ, Wang JY. Comparing efficacy and safety between Naldebain(R) and intravenous patient-controlled analgesia with fentanyl for pain management post-laparotomy: study protocol for a randomized controlled, non-inferior trial. Trials. 2019 Mar 18;20(1):173. doi: 10.1186/s13063-019-3260-4.
PubMed 30885242
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Compare the Efficacy and Safety of NALDEBAIN With Intravenous Patient-Controlled Analgesia With Fentanyl for the Treatment of Post-Laparotomy Surgery
- ClinicalTrials.gov ID
- NCT03296488
- Acronym / sponsor ID
- KMUHIRB-F(I)-20170089
- Conditions
- Pain, Postoperative
- Keywords
- post-laparotomy wound pain, NALDEBAIN (150 mg Nalbuphine Sebacate), PCA (patient-control-ed alagesia)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 17 Aug 2017 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 28 Sep 2017 (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.
The primary objective of this study is to determine the safety and efficacy of single doses of intramuscular NALDEBAIN on patients scheduled to undergo elective laparotomy. This will be performed by administering NALDEBAIN pre-operatively to subjects scheduled to undergo elective laparotomy, and assessing the safety and efficacy of the drug compared to PCA with fentanyl. The study will demonstrate whether single use of NALDEBAIN is noninferior to PCA with fentanyl or not.
Detailed description
Screening (Days -30 to -1) (All Study Subjects)
The nature of the study, as well as the potential risks and benefits associated with study participation, will be fully explained to all potential subjects. The following will then be obtained:
- Informed consent.
- Demographic information, including sex, age, BMI and type of surgery.
- Vital signs, including temperature, respiratory rate, blood pressure and heart rate.
- Medical history, including medication use and history of allergy.
- Physical examination.
- Laboratory testing, including hematological and biochemical tests, and urinalysis.
- ECG and X-ray.
Study Day -1 (All Eligible Subjects)
- Eligible subjects will be required to check into the clinical site before surgery (Day -1). The following procedures will be performed upon check-in:
- Review inclusion/exclusion criteria
- Randomization
- Review of concomitant medications
- Review of adverse events
- Additional laboratory tests will be requested as needed deciding by the investigator.
- All eligible subjects will hospitalize and be randomized into one of two treatment groups:
- Group 1 - Intramuscular NALDEBAIN.
- Group 2 - Intravenous PCA with fentanyl. Group 1 will receive single dose of NALDEBAIN (150 mg Nalbuphine Sebacate) intramuscularly 24±12 hours before surgery.
Group 2 will receive intravenous patient-controlled analgesia with fentanyl through 48 hours after surgery.
- Pain assessment: group 1 and 2 will rate their pain intensity using a VAS pain scale prior dosing or at Day -1 respectively.
- Brief Pain Inventory (BPI) will be evaluated at Day -1.
- Vital signs will be checked prior to dosing and once daily before Day 6.
- Group 1 received NALDEBAIN will evaluate injection site within 1 hour prior to dosing.
Study Day 0-5 All subjects will be given general anesthesia prior to their scheduled surgical procedure.
If patients need additional medication for treatment of pain, Ketorolac and Morphine could be used as supplemental analgesics when they needed.
After surgery, the following evaluations will be performed:
- Pain assessment: All subjects will rate their average pain intensity using a VAS pain scale. The assessment will perform before the first use of PCA or supplemental analgesics and at 4±1, 24±2, 32±3, 48±4 hours and once daily on Days 3 to Day 5 after the surgery.
- Brief Pain Inventory (BPI) will be evaluated at Day 2.
- Vital signs (temperature, respiratory rate, blood pressure and heart rate) will be checked once daily before Day 6.
- In Group 1 (NALDEBAIN group), the injection site will be evaluated once daily before final visit.
- Review of concomitant medication and adverse event record.
- In Group 2 (PCA group), the amount of fentanyl used will be recorded on Days 0 through 2.
Study Day 6 Evaluate the following items at Day 6.
- Pain assessment: Subjects will rate their pain intensity in the patient diary.
- Brief Pain Inventory (BPI) will be evaluated.
- Vital signs (temperature, respiratory rate, blood pressure and heart rate) will be checked.
- Injection site evaluation.
- Review of the adverse event record.
- Review of concomitant medication. Final Visit (Day of Discharge, Day 6~30)
- Vital signs (temperature, respiratory rate, blood pressure and heart rate) will be checked
- Injection site evaluation
- Laboratory tests, including hematological and biochemical tests, and urinalysis.
- Patient satisfaction: At the final visit, each subject was asked the following question: "How satisfied were you with your postsurgical analgesia"? Subjects were asked to classify themselves as either "highly satisfied", "satisfied", "uncertain", "dissatisfied", or "very dissatisfied".
- Physical examination.
- Review of the adverse event record.
- Review of concomitant medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nalbuphine Sebacate | Experimental | Drug: Nalbuphine Sebacatereceive single dose of NALDEBAIN (150 mg Nalbuphine Sebacate, 75 mg/ml, 2 ml/vial) intramuscularly 24±12 hours before surgery. |
| Fentanyl Citrate | Active comparator | Drug: Fentanyl Citratereceive intravenous patient-controlled analgesia with fentanyl through 48 hours 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)
- Male or female who is among 20 to 80 years of age at screening.
- Scheduled to electively undergo open-laparotomy.
- American Society of Anesthesiology Physical Class 1-3.
- Ability and willingness to provide informed consent
Key exclusion criteria (8 listed)
- Body mass index less than 18 kg/m2 or greater than 30 kg/m2.
- History of previous open-laparotomy.
- Surgery with major complication, or need blood transfusion.
- History of hypersensitivity or adverse reaction to local anesthetics, opioid, or any ingredient of the medications administered in this study.
- Severe comorbidity.
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 |
|---|---|---|
| Nalbuphine SebacateAlso: NALDEBAINintramuscular single dose of NALDEBAIN 24±12 hours before surgery. | Drug | Nalbuphine Sebacate |
| Fentanyl CitrateAlso: PCA with fentanylIntravenous patient-controlled analgesia with fentanyl through 48 hours after surgery. | Drug | Fentanyl Citrate |
Primary outcome
pain assessment (post-OP 48 hours)
Time frame: During post-OP 48 hours
Pain assessment (time-specific pain intensity) calculated as the area under the curve of VAS pain intensity scores through 48 hours after surgery.
5 secondary outcomes
supplemental analgesics
Time frame: From post-OP to Day 6
Pain assessment (post-OP to Day 6)
Time frame: From post-OP to Day 6
Brief Pain Inventory
Time frame: pre-OP Day -1, post-OP Day 2 and Day 6
Patient satisfaction
Time frame: On discharge Day, between post-OP Day 7 and Day 14
Length of postoperative hospital stay
Time frame: From post-OP to Discharge Day, about 1 to 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2017.
- Derived from this study: PubMed 32990938Chang TK, Huang CW, Su WC, Tsai HL, Ma CJ, Yeh YS, Chen YC, Li CC, Cheng KI, Su MP, Wang JY. Extended-Release Dinalbuphine Sebacate Versus Intravenous Patient-Controlled Analgesia with Fentanyl for Postoperative Moderate-to-Severe Pain: A Randomized Controlled Trial. Pain Ther. 2020 Dec;9(2):671-681. doi: 10.1007/s40122-020-00197-x. Epub 2020 Sep 29.
- Derived from this study: PubMed 30885242Tsai HL, Chang TK, Su WC, Yeh YS, Huang CW, Ma CJ, Wang JY. Comparing efficacy and safety between Naldebain(R) and intravenous patient-controlled analgesia with fentanyl for pain management post-laparotomy: study protocol for a randomized controlled, non-inferior trial. Trials. 2019 Mar 18;20(1):173. doi: 10.1186/s13063-019-3260-4.
- 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.
Chung-Ho Memorial Hospital, Kaohsiung Medical University:
Kaohsiung City, Taiwan
Jaw-Yuan Wang, PhD study chair
Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University
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 Nalbuphine Sebacate and Fentanyl Citrate in people with Pain, Postoperative, run by Kaohsiung Medical University Chung-Ho Memorial 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 8 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 28 Sep 2017. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain assessment (post-OP 48 hours) (time frame: During post-OP 48 hours). 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 NCT03296488, which also lists 2 linked publications.
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 28 Sep 2017.