Naldebain for Control of Post-Cesarean Section Pain

Summary

Inadequate postoperative pain management can lead to physical and psychological distress in patients as well as impact surgical wound healing and increase the risk of developing postoperative delirium and cardiopulmonary and thromboembolic events. Severe postoperative pain may also result in the development of chronic post-surgical pain (CPSP), which in turn can lead to prolonged use of opioids and increased health-care costs. A descriptive survey study in 60 postpartum women who received cesarean section suggested that the presence of postoperative pain significantly reduced the willingness of breastfeeding and infant care. The incidence of CPSP after cesarean delivery has been reported to vary from 1% to 18% up to 1 year after operation. Patient-controlled epidural analgesia (PCEA) is considered as the standard pain management strategy for post-cesarean pain. However, correct placement of epidural catheter for effective postoperative pain management is more technical demanding, and accidental dural puncture is associated with increased risk of postdural puncture headache. It also increases risk of other complications, including urinary retention, systemic toxicity of local anesthetics and formation of epidural hematoma. Therefore, the development of a safe, conveniently operated, and long-lasting analgesic strategy, which serves as background pain control modality up to several days after cesarean section should provide clinically beneficial advantages in the management of acute postoperative pain and prevention of CPSP in postpartum women. Naldebain® is prodrug of nalbuphine, which was approved by the Taiwan FDA in 2017. Naldebain® is rapidly hydrolyzed by tissue of plasma esterase to release nalbuphine. The bioavailability of nalbuphine following intramuscular injection Naldebain® was 85.4%, and it took approximately 6 days for the complete release of Naldebain® into the blood circulation. Therefore, a single parenteral injection of Naldebain® could provide long lasting analgesic effect in several phase II trials. However, Naldebain® has not been tested in the pain control after cesarean section. Therefore, this PI-initiated prospective, randomized, open-label, non-inferiority trial aims to investigate the clinical efficacy of Naldebain® in management of acute postoperative pain in term parturient who receive elective cesarean section to provide analgesic effect that is not inferior to the standard PCEA and prevent the development of CPSP.

Conditions

• Post Operative Pain, Acute
• Post Operative Pain, Chronic
• Cesarean Section

Interventions

DEVICE

Patient-controlled epidural analgesia (PCEA)

Epidural analgesia is a technique of neuraxial block by placement of a 20G polyether epidural catheter into the epidural lumen and fixed at the desired depth, and analgesic effect is usually achieved by administration of mixture of local anesthetics and opioids using a programmed pump.

DRUG

Naldebain®

Naldebain dissolved in benzyl benzoate and sesame oil (a total volume of 2ml) will be prepared in a 5-ml syringe 30 min before administration. Intramuscular injection into the gluteal muscles will be performed by an anesthesiologist under sonography-guidance.

Sponsors & Collaborators

• E-DA Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

20 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-09-01

Primary Completion

2023-06-30

Completion

2023-10-01

Countries

• Taiwan

Study Locations