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

• Conditions: Post Operative Pain; Caesarean Section; Analgesia
• Interventions: Drug: Dinalbuphine sebacate

• Registration Number: NCT05446311
• Lead Sponsor: 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.

Study Timeline

• Status Verified: 2022-06
• Study First Submitted: 2022-06-30
• Study First Submitted QC: 2022-06-30
• Last Update Submitted: 2022-06-30
• Study First Posted: 2022-07-06
• Last Update Posted: 2022-07-06
• Study Start: 2022-07-15
• Primary Completion: 2022-12-20
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 20

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
DS group	Dinalbuphine sebacate	Subjects going to receive dinalbuphine sebacate for post-cesarean section pain.

Primary Outcome Measures

Name	Time	Method
Incidence of complication	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 Outcome Measures

Name	Time	Method
Consumption of analgesics	Within 5 days after delivery	Analgesics consumed during stay of hospital are recorded.
Concentration of nalbuphine in breast milk	Within 5 days after delivery	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.
Post-cesarean section pain intensity	Within 5 days after delivery	Pain intensity is assessed by numerical rating scale (NRS) twice daily during stay
Concentration of dinalbuphine sebacate in breast milk	Within 5 days after delivery	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.