Clinical trial NCT05446311: Naldebain® Extended-release Injection After Cesarean Section in Pain Management
Official title: Naldebain® Extended-release Injection After Cesarean Section in Pain Management: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Post Operative Pain
Caesarean Section
Analgesia
Keywords: Dinalbuphine Sebacate
NALDEBAIN
Extended-release analgesics
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
First posted: 2022-07-06
Enrollment: 20
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects going to have cesarean section in Tri-Service General Hospital.

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.

Eligibility criteria: Inclusion Criteria:

1. Female aged 20 to 45 years.
2. Going to have cesarean section and use dinalbuphine sebacate to alleviate postoperative pain.
3. Cesarean section scheduled between the 34th and 41st week of gestation.
4. ASA I or II.
5. Willing to comply with study protocol and give written informed consent.

Exclusion Criteria:

1. With contraindication to opioids.
2. Chronic use or abuse of opioids.
3. Underlying disease which contribute to abnormal lactation, such as mastitis.
4. Diagnosed with gestational diabetes mellitus and administration of insulin is required.
5. Diagnosed with pre-eclampsia or eclampsia.
6. Unsuitable for participation judged by investigator.

Primary outcomes:
measure: Incidence of complication
timeFrame: Within 5 days after injection of dinalbuphine sebacate
Secondary outcomes:
measure: Post-cesarean section pain intensity
timeFrame: Within 5 days after delivery
measure: Consumption of analgesics
timeFrame: Within 5 days after delivery
measure: Concentration of nalbuphine in breast milk
timeFrame: Within 5 days after delivery
measure: Concentration of dinalbuphine sebacate in breast milk
timeFrame: Within 5 days after delivery
Other outcomes:
Locations:
Study officials:
affiliation: Tri-Service General Hospital
name: Chi-Kang Lin, MD
role: PRINCIPAL_INVESTIGATOR
References: