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

NCT05446311 | Unknown

• 1 other identifier: TSGH-OBS-111-01
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Post Operative Pain; Caesarean Section; Analgesia

Keywords

Dinalbuphine Sebacate; NALDEBAIN; Extended-release analgesics

Outcome Measures

Primary Outcomes (1)

• 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 (4)

• Post-cesarean section pain intensity

  Within 5 days after delivery

• Consumption of analgesics

  Within 5 days after delivery

• Concentration of nalbuphine in breast milk

  Within 5 days after delivery

• Concentration of dinalbuphine sebacate in breast milk

  Within 5 days after delivery

Study Arms (1)

DS group

Subjects going to receive dinalbuphine sebacate for post-cesarean section pain.

Drug: Dinalbuphine sebacate

Interventions

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.

Also known as: NALDEBAIN

DS group

Eligibility Criteria

• Age: 20 Years - 45 Years
• Gender Eligibility Details: Subjects going to undergo cesarean section
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tri-Service General Hospital: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Breast milk

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Chi-Kang Lin, MD

  Tri-Service General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chi-Kang Lin, MD

CONTACT

+886-2-87923311; kung568@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: June 30, 2022
• First Posted: July 6, 2022
• Study Start: July 15, 2022
• Primary Completion: December 20, 2022
• Study Completion: December 31, 2022
• Last Updated: July 6, 2022

Record last verified: 2022-06