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

Analgesia Clinical Trial

Official title:

Naldebain® Extended-release Injection After Cesarean Section in Pain Management: a Prospective Observational Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05446311
• Other study ID #: TSGH-OBS-111-01
• Status: Not yet recruiting
• Start date: July 15, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: June 2022
• Source: Tri-Service General Hospital
• Contact: Chi-Kang Lin, MD
• Phone: +886-2-87923311
• Email: kung568[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 31, 2022
• Est. primary completion date: December 20, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Analgesia
• Caesarean Section
• Pain, Postoperative
• Post Operative Pain

Intervention

Drug:
• Dinalbuphine sebacate
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tri-Service General Hospital

Outcome

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