Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06387303
Status:
RECRUITING
Last Update Posted:
2024-05-02
First Post:
2024-04-23
Brief Title:
Pain Control and Quality of Recovery After Intravenous Methadone Versus Intrathecal Morphine in Major Abdominal Surgery
Sponsor:
University of Virginia
Organization:
University of Virginia
Study Overview
Official Title:
Pain Control and Quality of Recovery After Intravenous Methadone Versus Intrathecal Morphine in Major Abdominal Surgery
Status:
RECRUITING
Status Verified Date:
2024-08
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:
Moderate to severe postoperative pain is relatively common after major abdominal surgery It is associated with less than optimal surgical experience poor quality of recovery and the development of persistent postsurgical pain Opioids remain a significant component of postoperative pain management Side effects of opioids used for the treatment of postoperative pain include constipation pruritus nausea and vomiting Enhanced recovery after surgery ERAS protocols involve the utilization of multimodal analgesia Analgesic techniques used include epidural analgesia nerve blocks and Intrathecal IT administration of morph ne IT morphine reduces the postoperative opioid requirement for 18-24 hours after major abdominal surgery and reduces hospital length of stay LOS compared with epidural analgesia A significant number of patients who receive IT morphine still experience moderate to severe postoperative p in Additionally many patients refuse the invasive procedure or cannot receive IT morphine due to procedure contraindications thrombocytopenia andor coagulopathy
Intravenous IV methadone has a long analgesic half-life and has N-methyl-D-aspartate NMDA receptor antagonist and serotonin and norepinephrine reuptake inhibitor SNRI properties It has previously been shown to reduce postoperative opioid requirements postoperative nausea and vomiting PONV and postoperative pain scores in patients who underwent orthopedic abdominal complex spine and cardiac surg ry Similar findings have been shown in obstetric patients who underwent cesarean delivery under general anesthesia as well as patients who underwent gynecologic surgery IV methadone has however never been compared with IT morphine as a postoperative analgesic
The hypothesis is that intravenous IV methadone is non-inferior to IT morphine in patients who undergo major abdominal surg ry It offers the advantage of being a noninvasive analgesic modality that may contribute to decreasing opioid consumption during the first 72 hours postoperatively controlling postoperative pain and improving the quality of recovery after surgery
Intravenous IV methadone has a long analgesic half-life and has N-methyl-D-aspartate NMDA receptor antagonist and serotonin and norepinephrine reuptake inhibitor SNRI properties It has previously been shown to reduce postoperative opioid requirements postoperative nausea and vomiting PONV and postoperative pain scores in patients who underwent orthopedic abdominal complex spine and cardiac surg ry Similar findings have been shown in obstetric patients who underwent cesarean delivery under general anesthesia as well as patients who underwent gynecologic surgery IV methadone has however never been compared with IT morphine as a postoperative analgesic
The hypothesis is that intravenous IV methadone is non-inferior to IT morphine in patients who undergo major abdominal surg ry It offers the advantage of being a noninvasive analgesic modality that may contribute to decreasing opioid consumption during the first 72 hours postoperatively controlling postoperative pain and improving the quality of recovery after surgery
Detailed Description:
Moderate to severe postoperative pain is relatively common after major abdominal surgery It is associated with less than optimal surgical experience poor quality of recovery and the development of persistent postsurgical pain Opioids remain a significant component of postoperative pain management Side effects of opioids used for the treatment of postoperative pain include constipation pruritus nausea and vomiting Enhanced recovery after surgery ERAS protocols involve the utilization of multimodal analgesia Analgesic techniques used include epidural analgesia nerve blocks and Intrathecal IT administration of morph ne IT morphine reduces the postoperative opioid requirement for 18-24 hours after major abdominal surgery and reduces hospital length of stay LOS compared with epidural analgesia A significant number of patients who receive IT morphine still experience moderate to severe postoperative p in Additionally many patients refuse the invasive procedure or cannot receive IT morphine due to procedure contraindications thrombocytopenia andor coagulopathy
Intravenous IV methadone has a long analgesic half-life and has N-methyl-D-aspartate NMDA receptor antagonist and serotonin and norepinephrine reuptake inhibitor SNRI properties It has previously been shown to reduce postoperative opioid requirements postoperative nausea and vomiting PONV and postoperative pain scores in patients who underwent orthopedic abdominal complex spine and cardiac surg ry Similar findings have been shown in obstetric patients who underwent cesarean delivery under general anesthesia as well as patients who underwent gynecologic surgery IV methadone has however never been compared with IT morphine as a postoperative analgesic
The hypothesis is that intravenous IV methadone is non-inferior to IT morphine in patients who undergo major abdominal surg ry It offers the advantage of being a noninvasive analgesic modality that may contribute to decreasing opioid consumption during the first 72 hours postoperatively controlling postoperative pain and improving the quality of recovery after surgery
Intravenous IV methadone has a long analgesic half-life and has N-methyl-D-aspartate NMDA receptor antagonist and serotonin and norepinephrine reuptake inhibitor SNRI properties It has previously been shown to reduce postoperative opioid requirements postoperative nausea and vomiting PONV and postoperative pain scores in patients who underwent orthopedic abdominal complex spine and cardiac surg ry Similar findings have been shown in obstetric patients who underwent cesarean delivery under general anesthesia as well as patients who underwent gynecologic surgery IV methadone has however never been compared with IT morphine as a postoperative analgesic
The hypothesis is that intravenous IV methadone is non-inferior to IT morphine in patients who undergo major abdominal surg ry It offers the advantage of being a noninvasive analgesic modality that may contribute to decreasing opioid consumption during the first 72 hours postoperatively controlling postoperative pain and improving the quality of recovery after surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None