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

Tri-Service General Hospital

Status: Not yet enrolling

Conditions: Caesarean Section; Analgesia; Post Operative Pain

Treatments: Drug: Dinalbuphine sebacate

Study type: Observational

Funder types: Other

Identifiers

NCT05446311

TSGH-OBS-111-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: Female

Ages: 20 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

20 participants in 1 patient group

DS group

Description:

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

Treatment:

Drug: Dinalbuphine sebacate