Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT06344169 |
Other study ID # |
DTCRD112(2)-I-15 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
Phase 2/Phase 3
|
First received |
|
Last updated |
|
Start date |
April 15, 2024 |
Est. completion date |
June 14, 2026 |
Study information
Verified date |
April 2024 |
Source |
Dalin Tzu Chi General Hospital |
Contact |
Chen-Fuh Lam, MD, PhD |
Phone |
8865-2648000 |
Email |
lamcf[@]mail.ncku.edu.tw |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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. Intrathecal morphine (ITM) injection is considered as the standard
pain management strategy for post-cesarean pain. However, the overall analgesic effect of ITM
is about 8-12h and it is associated with pruritus, nausea/vomiting, urinary retention,
constipation, mental status change, and respiratory depression. 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 ITM and
prevent the development of CPSP.
Description:
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.
Furthermore, the incidence of CPSP after cesarean delivery has been reported to vary from 1%
to 18% up to 1 year after operation. More specifically, an US nationwide survey reported that
79% of mothers who received cesarean section reported experiencing pain at the incision site
in the first two months and 18% had persistent pain at least 6 months after operation.
Placement of an epidural catheter can be used for epidural anesthesia during cesarean section
and continuous epidural infusions of opioids or combined with local anesthetic after cesarean
section can result in high-quality analgesia effect for postpartum and postsurgical pain.
Intrathecal injection of morphine (ITM) is considered as the standard pain management
strategies for post-cesarean pain in Taiwan. 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. ITM is associated
with severe mu-receptor agonist adverse reactions, such as pruritus, nausea/vomiting, urinary
retention, constipation, mental status change, and respiratory depression. Therefore, the
development of a safe, conveniently operated, and long-lasting non-mu agonism 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 development of CPSP in postpartum women.
Sebacoyl dinalbuphine ester Naldebain® (SDE) is prodrug of nalbuphine, which was approved by
the Taiwan FDA in 2017. SDE is rapidly hydrolyzed by tissue of plasma esterase to release
nalbuphine. The bioavailability of nalbuphine following intramuscular injection SDE was 85.4%
with a mean absorption time up to 145 h, and it took approximately 6 days for the complete
release of SDE into the blood circulation. Therefore, a single parenteral injection of SDE
could provide long lasting analgesic effect in several phase II trials. However, SDE 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 SDE 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
ITM. A single intramuscular injection of SDE may also prevent the development of CPSP after
cesarean delivery, as SDE can provide prolonged analgesic effect for up to 7 days.