Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06344169
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-22
First Post:
2024-03-27
Brief Title:
Dinalbuphine Ester Naldebain for Pain Management After Cesarean Section
Sponsor:
Dalin Tzu Chi General Hospital
Organization:
Dalin Tzu Chi General Hospital
Study Overview
Official Title:
Efficacy of Parenteral Injection of an Extended Release Kappa-receptor Opioid Sebacoyl Dinalbuphine Ester for Pain Management After Cesarean Section a Randomized Open-label Non-inferiority Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 nauseavomiting 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 854 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
Detailed 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 nauseavomiting 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 854 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
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 854 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None