Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06525740
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-24
Brief Title:
Methadone Versus Intrathecal Hydromorphone for Postoperative Pain Relief in Gynecologic Cancer Undergoing Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Methadone Versus Intrathecal Hydromorphone for Postoperative Analgesia in Patients Undergoing Surgery for Gynecologic Malignancy Via Midline Laparotomy Receiving Liposomal Bupivacaine
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase IV trial compares methadone versus hydromorphone given in the fluid-filled space between the thin layers of tissue that cover the brain and spinal cord intrathecal for postoperative pain relief in patients with gynecologic cancer undergo surgery Methadone binds to opioid receptors in the central nervous system and is a long-acting opioid pain medication Intrathecal hydromorphone works by changing the way the brain and nervous system respond to pain and is similar to an epidural This trial may help researchers determine if methadone works as well as intrathecal hydromorphone for pain relief after surgery in patients with gynecologic cancer
Detailed Description:
PRIMARY OBJECTIVE
I To determine whether intravenous methadone can provide comparable analgesia to an intrathecal injection of hydromorphone
OUTLINE Patients are randomized to 1 of 2 arms
ARM I Patients receive methadone intravenously IV during induction of general anesthesia for standard of care SOC surgery
ARM II Patients receive hydromorphone intrathecally IT prior to induction of general anesthesia for SOC surgery
After completion of study intervention patients are followed up at 1 month
I To determine whether intravenous methadone can provide comparable analgesia to an intrathecal injection of hydromorphone
OUTLINE Patients are randomized to 1 of 2 arms
ARM I Patients receive methadone intravenously IV during induction of general anesthesia for standard of care SOC surgery
ARM II Patients receive hydromorphone intrathecally IT prior to induction of general anesthesia for SOC surgery
After completion of study intervention patients are followed up at 1 month
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None