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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-15

Study Completion Date

2022-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Post Operative Pain Caesarean Section Analgesia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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DS group

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

Dinalbuphine sebacate

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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NALDEBAIN

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No