Naldebain® Extended-release Injection After Cesarean Sect... | NCT05446311

Studies
Naldebain® Extended-release Injection After Cesarean Section in Pain Management

NCT05446311

Sponsor

Tri-Service General Hospital (TSGH)

Status

Unknown status

Last Update Posted

Jul 6, 2022Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Post Operative Pain
Caesarean Section
Analgesia

Interventions

Dinalbuphine sebacate

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 15, 2022Estimated

Primary Completion Date

Dec 20, 2022Estimated

Completion Date

Dec 31, 2022Estimated

First Submitted Date

Jun 30, 2022

First Submission Date that Met QC Criteria

Jun 30, 2022

First Posted Date

Jul 6, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 30, 2022

Last Update Posted Date

Jul 6, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Chi-Kang Lin, Director, Tri-Service General Hospital (TSGH)Principal Investigator

Lead Sponsor

Tri-Service General Hospital (TSGH)OTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DS group		Subjects going to receive dinalbuphine sebacate for post-cesarean section pain.	Drug: Dinalbuphine sebacate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dinalbuphine sebacate	Drug	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Within 5 days after injection of dinalbuphine sebacate

Secondary Outcomes

Measure	Description	Time Frame
Post-cesarean section pain intensity	Pain intensity is assessed by numerical rating scale (NRS) twice daily during stay	Within 5 days after delivery
Consumption of analgesics	Analgesics consumed during stay of hospital are recorded.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Subjects going to undergo cesarean section

Minimum Age

20 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Subjects going to have cesarean section in Tri-Service General Hospital.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Chi-Kang Lin, MD	Contact	+886-2-87923311	10083	kung568@gmail.com

Overall Officials

Name	Affiliation	Role
Chi-Kang Lin, MD	Tri-Service General Hospital (TSGH)	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative
D000377	Agnosia

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

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Browse Branches

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