AnalgesiaPhase 4NCT04962152
Naldebain and Video-assisted Thoracoscopic Surgery
A Phase 4 study of Analgesia and Nausea and Vomiting, Postoperative, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
To evaluate the postoperative analgesic effect of combined use of Naldebain® and thoracic paravertebral block in thoracoscopic surgery Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Analgesia, Nausea and Vomiting, Postoperative, Itching
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Jul 2021to 7 May 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) Subject's age: 20~65 years old
- 2) American Society of Anesthesiologists (ASA) Physical Status classification: I~III
- 3) Patients who need postoperative pain relief due to thoracoscopic surgery
Who cannot join
- 1. The patient suffers from a communication disorder
- 2. The patient has coagulopathy
- 3. Sick with obvious heart, lung, liver or kidney disease
- 4. The patient's body mass index is less than 18.5 or greater than 35
- 5. Pregnant patients
- 6. Patients who took opioids for more than three weeks before surgery
Show all 9Show fewer
- 7. Patients with contraindications to local anesthesia
- 8. Patients with a history of chronic pain
- 9. Patients with a history of drug allergy to Naldebain
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Anesthesiology, Kaohsiung Medical University Hospital
Kaohsiung City, 833
Hung-Te Hsu, MD, PhD, +88673121101 ext. 7033, hdhsu1228@hotmail.com
About this study
Official title: To Explore the Effects of Naldebain Combined With Thoracic Paravertebral Block in Video-assisted Thoracoscopic Surgery.
To evaluate the postoperative analgesic effect of combined use of Naldebain® and thoracic paravertebral block in thoracoscopic surgery
Read the detailed description
Video-assisted thoracoscopic surgery (VATS) can be associated with stronger postoperative pain than is commonly believed. Pain control after thoracic surgery is important because increased acute pain has been shown to increase the incidence of chronic pain, and untreated pain may lead to increased morbidity. It is generally accepted to introduce multimodal analgesic strategies based on regional blockade, opioids and non-steroidal anti-inflammatory drugs.
Paravertebral block (PVB) involves the injection of local anesthetic into a wedge-shaped space lateral to the spinal nerves as they emerge from intervertebral foramina. It produces ipsilateral somatosensory and sympathetic nerve blockade effective for anesthesia as well as for management of pain of unilateral origin from the chest and abdomen. So far, thoracic paravertebral block (TPVB) is the most common technique used for patients undergoing VATS. TPVB may be useful after VATS because a single injection of local anesthesia may provide effective analgesia for the intense short-duration pain that patients experience.
Nalbuphine sebacate (Naldebain®) is a long-acting prodrug of nalbuphine developed for meeting the unmet medical need of long-acting analgesics. It is a synthetic opioid agonist-antagonist analgesic of the phenanthrene series. It is chemically related to both the widely used opioid antagonist, naloxone, and the potent opioid analgesic, oxymorphone. The currently proposed clinical use of nalbuphine sebacate is a single dose of Naldebain® administered intramuscularly approximately 24 h prior to the planned surgery for pain relief.
The purpose of this study is to determine the safety and efficacy of TPVB combined with a single dose of intramuscular Naldebain® administered preoperatively to patients scheduled to undergo VATS.
- Conditions
- Analgesia, Nausea and Vomiting, Postoperative, Itching, Injection Site Reaction, Satisfaction, Patient
- Being tested
- Nalbuphine Sebacate or Sesame oil (placebo)
- Medical subject headings
- Agnosia, Postoperative Nausea and Vomiting, Pruritus, Injection Site Reaction, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nalbuphine Sebacate or Sesame oil (placebo)Drug
Also called Naldebain ER
ultrasound-guided intramuscular injection after the induction of anesthesia immediately
| Study group | Role | What they receive |
|---|---|---|
| Group Naldebain | Experimental | ultrasound-guided intramuscular injection of Naldebain 150mg after the induction anesthesia immediately Receives: Drug: Nalbuphine Sebacate or Sesame oil (placebo) |
| Group Placebo | Placebo comparator | ultrasound-guided intramuscular injection of sesame oil (placebo) 2mL after the induction anesthesia immediately Receives: Drug: Nalbuphine Sebacate or Sesame oil (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative analgesic effect
Use the visual analogue scale (VAS) score to assess the degree of pain after surgery
Measured: During the first one hour in the recovery room, the pain intensity was evaluated every 15 minutes.
postoperative analgesic effect
Use the visual analogue scale (VAS) score to assess the degree of pain after surgery
Measured: the pain intensity was evaluated at 3 hours after surgery.
postoperative analgesic effect
Use the visual analogue scale (VAS) score to assess the degree of pain after surgery
Measured: the pain intensity was evaluated at 6 hours after surgery.
postoperative analgesic effect
Use the visual analogue scale (VAS) score to assess the degree of pain after surgery
Measured: the pain intensity was evaluated at 12 hours after surgery.
postoperative analgesic effect
Use the visual analogue scale (VAS) score to assess the degree of pain after surgery
Measured: the pain intensity was evaluated at 24 hours after surgery.
postoperative analgesic effect
Use the visual analogue scale (VAS) score to assess the degree of pain after surgery
Measured: the pain intensity was evaluated at 36 hours after surgery.
postoperative analgesic effect
Use the visual analogue scale (VAS) score to assess the degree of pain after surgery
Measured: the pain intensity was evaluated at 48 hours after surgery.
postoperative analgesic effect
Use the visual analogue scale (VAS) score to assess the degree of pain after surgery
Measured: the pain intensity was evaluated at 72 hours after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start7 Jul 2021
- Primary completion7 May 2024 (estimated)
- Study completion7 May 2024 (estimated)
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 AnalgesiaStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hung-Te Hsu, MD, PhD, Principal investigator, Department of anesthesiology, Kaohsiung Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04962152
- Sponsor's protocol ID
- KMUHIRB-F(I)-20210087
- Status last verified
- Jul 2023
- First submitted
- 5 Jul 2021
- Last updated
- 21 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hsu HT, Ma CW, Chang PC, Kuo YW, Gau TP, Liu YW, Liu YC, Chou SH, Cheng KI. Effect of Dinalbuphine sebacate on postoperative multimodal analgesic strategy in video-assisted thoracoscopic surgery: a double-blind randomized controlled trial. BMC Anesthesiol. 2025 May 17;25(1):252. doi: 10.1186/s12871-025-03118-7.
PubMed 40382572
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Explore the Effects of Naldebain Combined With Thoracic Paravertebral Block in Video-assisted Thoracoscopic Surgery.
- ClinicalTrials.gov ID
- NCT04962152
- Acronym / sponsor ID
- KMUHIRB-F(I)-20210087
- Conditions
- Analgesia, Nausea and Vomiting, Postoperative, Itching, Injection Site Reaction, Satisfaction, Patient
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- 7 May 2024 (estimated)
- Study completion
- 7 May 2024 (estimated)
- First posted
- 14 Jul 2021 (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 evaluate the postoperative analgesic effect of combined use of Naldebain® and thoracic paravertebral block in thoracoscopic surgery
Detailed description
Video-assisted thoracoscopic surgery (VATS) can be associated with stronger postoperative pain than is commonly believed. Pain control after thoracic surgery is important because increased acute pain has been shown to increase the incidence of chronic pain, and untreated pain may lead to increased morbidity. It is generally accepted to introduce multimodal analgesic strategies based on regional blockade, opioids and non-steroidal anti-inflammatory drugs.
Paravertebral block (PVB) involves the injection of local anesthetic into a wedge-shaped space lateral to the spinal nerves as they emerge from intervertebral foramina. It produces ipsilateral somatosensory and sympathetic nerve blockade effective for anesthesia as well as for management of pain of unilateral origin from the chest and abdomen. So far, thoracic paravertebral block (TPVB) is the most common technique used for patients undergoing VATS. TPVB may be useful after VATS because a single injection of local anesthesia may provide effective analgesia for the intense short-duration pain that patients experience.
Nalbuphine sebacate (Naldebain®) is a long-acting prodrug of nalbuphine developed for meeting the unmet medical need of long-acting analgesics. It is a synthetic opioid agonist-antagonist analgesic of the phenanthrene series. It is chemically related to both the widely used opioid antagonist, naloxone, and the potent opioid analgesic, oxymorphone. The currently proposed clinical use of nalbuphine sebacate is a single dose of Naldebain® administered intramuscularly approximately 24 h prior to the planned surgery for pain relief.
The purpose of this study is to determine the safety and efficacy of TPVB combined with a single dose of intramuscular Naldebain® administered preoperatively to patients scheduled to undergo VATS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Naldebain | Experimental | Drug: Nalbuphine Sebacate or Sesame oil (placebo)ultrasound-guided intramuscular injection of Naldebain 150mg after the induction anesthesia immediately |
| Group Placebo | Placebo comparator | Drug: Nalbuphine Sebacate or Sesame oil (placebo)ultrasound-guided intramuscular injection of sesame oil (placebo) 2mL after the induction anesthesia immediately |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1) Subject's age: 20~65 years old
- 2) American Society of Anesthesiologists (ASA) Physical Status classification: I~III
- 3) Patients who need postoperative pain relief due to thoracoscopic surgery
Key exclusion criteria (9 listed)
- 1. The patient suffers from a communication disorder
- 2. The patient has coagulopathy
- 3. Sick with obvious heart, lung, liver or kidney disease
- 4. The patient's body mass index is less than 18.5 or greater than 35
- 5. Pregnant patients
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 Sebacate or Sesame oil (placebo)Also: Naldebain ERultrasound-guided intramuscular injection after the induction of anesthesia immediately | Drug | Group Naldebain, Group Placebo |
Primary outcome
postoperative analgesic effect
Time frame: During the first one hour in the recovery room, the pain intensity was evaluated every 15 minutes.
Use the visual analogue scale (VAS) score to assess the degree of pain after surgery
postoperative analgesic effect
Time frame: the pain intensity was evaluated at 3 hours after surgery.
Use the visual analogue scale (VAS) score to assess the degree of pain after surgery
postoperative analgesic effect
Time frame: the pain intensity was evaluated at 6 hours after surgery.
Use the visual analogue scale (VAS) score to assess the degree of pain after surgery
postoperative analgesic effect
Time frame: the pain intensity was evaluated at 12 hours after surgery.
Use the visual analogue scale (VAS) score to assess the degree of pain after surgery
postoperative analgesic effect
Time frame: the pain intensity was evaluated at 24 hours after surgery.
Use the visual analogue scale (VAS) score to assess the degree of pain after surgery
postoperative analgesic effect
Time frame: the pain intensity was evaluated at 36 hours after surgery.
Use the visual analogue scale (VAS) score to assess the degree of pain after surgery
postoperative analgesic effect
Time frame: the pain intensity was evaluated at 48 hours after surgery.
Use the visual analogue scale (VAS) score to assess the degree of pain after surgery
postoperative analgesic effect
Time frame: the pain intensity was evaluated at 72 hours after surgery.
Use the visual analogue scale (VAS) score to assess the degree of pain after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Derived from this study: PubMed 40382572Hsu HT, Ma CW, Chang PC, Kuo YW, Gau TP, Liu YW, Liu YC, Chou SH, Cheng KI. Effect of Dinalbuphine sebacate on postoperative multimodal analgesic strategy in video-assisted thoracoscopic surgery: a double-blind randomized controlled trial. BMC Anesthesiol. 2025 May 17;25(1):252. doi: 10.1186/s12871-025-03118-7.
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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-Te Hsu, MD, PhD principal investigator
Department of anesthesiology, Kaohsiung 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 of Analgesia and Nausea and Vomiting, 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 3 inclusion and 9 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 21 Mar 2024. 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. Some participants in this study may receive a placebo. 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-Te Hsu, MD, PhD (+88673121101 ext. 7033, hdhsu1228@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative analgesic effect (time frame: During the first one hour in the recovery room, the pain intensity was evaluated every 15 minutes.). The study lists 8 primary outcomes in all. 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 NCT04962152, 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 21 Mar 2024.