Naldebain® Extended-release Injection After Cesarean Section in Pain Management: a Prospective Observational Study
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Tri-Service General Hospital
- Enrollment
- 20
- Primary Endpoint
- Incidence of complication
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 20 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
DS group
Subjects going to receive dinalbuphine sebacate for post-cesarean section pain.
Intervention: Dinalbuphine sebacate (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Consumption of analgesics(Within 5 days after delivery)
- Concentration of nalbuphine in breast milk(Within 5 days after delivery)
- Post-cesarean section pain intensity(Within 5 days after delivery)
- Concentration of dinalbuphine sebacate in breast milk(Within 5 days after delivery)
Investigators
Chi-Kang Lin
Director
Tri-Service General Hospital