Naldebain for Control of Post-Cesarean Section Pain
Status:
Not yet recruiting
Trial end date:
2023-10-01
Target enrollment:
Participant gender:
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.