Post Operative PainNCT05446311
Naldebain® Extended-release Injection After Cesarean Section in Pain Management
An observational study of Post Operative Pain and Caesarean Section, run by Tri-Service General Hospital (TSGH).
Trial summary
Cesarean section is one of the surgeries most commonly leading to postoperative severe acute pain. It was reported that the mean worst pain intensity reached to 6.14 one day after cesarean section in Germany. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Post Operative Pain, Caesarean Section, Analgesia
- What is being tested?
- Dinalbuphine sebacate
- Type of treatment
- Injection or infusion
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2022to 31 Dec 2022
- Phase
- Observational
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Subjects going to have cesarean section in Tri-Service General Hospital.
Who may be able to join
- Female aged 20 to 45 years.
- Going to have cesarean section and use dinalbuphine sebacate to alleviate postoperative pain.
- Cesarean section scheduled between the 34th and 41st week of gestation.
- ASA I or II.
- Willing to comply with study protocol and give written informed consent.
Who cannot join
- With contraindication to opioids.
- Chronic use or abuse of opioids.
- Underlying disease which contribute to abnormal lactation, such as mastitis.
- Diagnosed with gestational diabetes mellitus and administration of insulin is required.
- Diagnosed with pre-eclampsia or eclampsia.
- Unsuitable for participation judged by investigator.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Naldebain® Extended-release Injection After Cesarean Section in Pain Management: a Prospective Observational Study
Cesarean section is one of the surgeries most commonly leading to postoperative severe acute pain. It was reported that the mean worst pain intensity reached to 6.14 one day after cesarean section in Germany. Inadequate pain management may result in the cardiorespiratory complications, late recovery, and postoperative chronic pain. According to a series of pain management article published in the Lancent in 2019, the incidence of post-cesarean section chronic pain was 55%, including 12% of severe chronic pain. Extended-release dinalbuphine sebacate, a prodrug of nalbuphine, is a novel analgesic developed in Taiwan and the indication is moderate to severe postoperative pain. After intramuscular injected, dinalbuphine sebacate will be released to blood stream and immediately hydrolyzed. In Taiwan, dinalbuphine sebacate has been used for alleviating pain after several types of surgeries, such as colorectal surgery, orthopaedics, gynecology and obstetrics. However, few post-marketing studies investigated the efficacy and safety of dinalbuphine sebacate.
Read the detailed description
This is an observational, prospective, single arm study. This study is aimed to investigate the efficacy and safety of dinalbuphine sebacate in subjects undergoing cesarean section. Written informed consent are obtained before subjects participate in the study. Eligible subjects will be visited twice daily during stay in hospital. Pain intensity, consumption of analgesics, adverse reaction, and the residues of dinalbuphine sebacate and nalbuphine in milk will all be analyzed.
- Conditions
- Post Operative Pain, Caesarean Section, Analgesia
- Being tested
- Dinalbuphine sebacate
- Keywords
- Dinalbuphine Sebacate, NALDEBAIN, Extended-release analgesics
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dinalbuphine sebacateDrug
Also called NALDEBAIN
After giving the birth, subjects are intramuscularly injected with a single dose of 150 mg of dinalbuphine sebacate (DS). DS is a prodrug of nalbuphine. After injeciton, DS are released to blood stream and hydrolyzed immediately. The onset of action is 12 to 24 hours and the analgesic effect can last about 5 to 7 days.
| Study group | Role | What they receive |
|---|---|---|
| DS group | Subjects going to receive dinalbuphine sebacate for post-cesarean section pain. Receives: Drug: Dinalbuphine sebacate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of complication
Analgesic-related complication occurring in the period of hospital stay will be recorded, such as dizziness, nausea, vomiting, and injection site reaction.
Measured: Within 5 days after injection of dinalbuphine sebacate
Secondary outcomes (4)
Post-cesarean section pain intensity
Pain intensity is assessed by numerical rating scale (NRS) twice daily during stay
Measured: Within 5 days after delivery
Consumption of analgesics
Analgesics consumed during stay of hospital are recorded.
Measured: Within 5 days after delivery
Concentration of nalbuphine in breast milk
Dinalbuphine sebacate is a prodrug of nalbuphine. After intramuscular injection, dinalbuphine sebacate are slowly released to blood stream and immediately hydrolyzed. The breast milk is collected twice daily within 5 days after cesarean section, and tested by HPLC.
Measured: Within 5 days after delivery
Concentration of dinalbuphine sebacate in breast milk
Dinalbuphine sebacate is a prodrug of nalbuphine. After intramuscular injection, dinalbuphine sebacate are slowly released to blood stream and immediately hydrolyzed. The breast milk is collected twice daily within 5 days after cesarean section, and tested by HPLC.
Measured: Within 5 days after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start15 Jul 2022 (estimated)
- Primary completion20 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chi-Kang Lin, Tri-Service General Hospital (TSGH)
- Investigators
- Chi-Kang Lin, MD, Principal investigator, Tri-Service General Hospital (TSGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05446311
- Sponsor's protocol ID
- TSGH-OBS-111-01
- Status last verified
- Jun 2022
- First submitted
- 30 Jun 2022
- Last updated
- 6 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Naldebain® Extended-release Injection After Cesarean Section in Pain Management: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05446311
- Acronym / sponsor ID
- TSGH-OBS-111-01
- Conditions
- Post Operative Pain, Caesarean Section, Analgesia
- Keywords
- Dinalbuphine Sebacate, NALDEBAIN, Extended-release analgesics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- 15 Jul 2022 (estimated)
- Primary completion
- 20 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 6 Jul 2022 (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.
Cesarean section is one of the surgeries most commonly leading to postoperative severe acute pain. It was reported that the mean worst pain intensity reached to 6.14 one day after cesarean section in Germany. Inadequate pain management may result in the cardiorespiratory complications, late recovery, and postoperative chronic pain. According to a series of pain management article published in the Lancent in 2019, the incidence of post-cesarean section chronic pain was 55%, including 12% of severe chronic pain. Extended-release dinalbuphine sebacate, a prodrug of nalbuphine, is a novel analgesic developed in Taiwan and the indication is moderate to severe postoperative pain. After intramuscular injected, dinalbuphine sebacate will be released to blood stream and immediately hydrolyzed. In Taiwan, dinalbuphine sebacate has been used for alleviating pain after several types of surgeries, such as colorectal surgery, orthopaedics, gynecology and obstetrics. However, few post-marketing studies investigated the efficacy and safety of dinalbuphine sebacate.
Detailed description
This is an observational, prospective, single arm study. This study is aimed to investigate the efficacy and safety of dinalbuphine sebacate in subjects undergoing cesarean section. Written informed consent are obtained before subjects participate in the study. Eligible subjects will be visited twice daily during stay in hospital. Pain intensity, consumption of analgesics, adverse reaction, and the residues of dinalbuphine sebacate and nalbuphine in milk will all be analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DS group | – | Drug: Dinalbuphine sebacateSubjects going to receive dinalbuphine sebacate for post-cesarean section pain. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Subjects going to have cesarean section in Tri-Service General Hospital.
Key inclusion criteria (5 listed)
- Female aged 20 to 45 years.
- Going to have cesarean section and use dinalbuphine sebacate to alleviate postoperative pain.
- Cesarean section scheduled between the 34th and 41st week of gestation.
- ASA I or II.
- Willing to comply with study protocol and give written informed consent.
Key exclusion criteria (6 listed)
- With contraindication to opioids.
- Chronic use or abuse of opioids.
- Underlying disease which contribute to abnormal lactation, such as mastitis.
- Diagnosed with gestational diabetes mellitus and administration of insulin is required.
- Diagnosed with pre-eclampsia or eclampsia.
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 |
|---|---|---|
| Dinalbuphine sebacateAlso: NALDEBAINAfter giving the birth, subjects are intramuscularly injected with a single dose of 150 mg of dinalbuphine sebacate (DS). DS is a prodrug of nalbuphine. After injeciton, DS are released to blood stream and hydrolyzed immediately. The onset of action is 12 to 24 hours and the analgesic effect can last about 5 to 7 days. | Drug | DS group |
Primary outcome
Incidence of complication
Time frame: Within 5 days after injection of dinalbuphine sebacate
Analgesic-related complication occurring in the period of hospital stay will be recorded, such as dizziness, nausea, vomiting, and injection site reaction.
4 secondary outcomes
Post-cesarean section pain intensity
Time frame: Within 5 days after delivery
Consumption of analgesics
Time frame: Within 5 days after delivery
Concentration of nalbuphine in breast milk
Time frame: Within 5 days after delivery
Concentration of dinalbuphine sebacate in breast milk
Time frame: Within 5 days after delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
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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.
Chi-Kang Lin, MD principal investigator
Tri-Service General Hospital (TSGH)
Questions about this trial
What is this clinical trial studying?
An observational study of Post Operative Pain and Caesarean Section, run by Tri-Service General Hospital (TSGH).
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 5 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: status not confirmed, as of the sponsor's last update on 6 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Chi-Kang Lin, MD (+886-2-87923311 ext. 10083, kung568@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of complication (time frame: Within 5 days after injection of dinalbuphine sebacate). 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 6 Jul 2022.