Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06536517
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-31
Brief Title:
The Effects of One-time Intraoperative Methadone During Laparoscopic Hysterectomy in Reducing Opioid Prescription
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Controlled Trial to Study the Effects of One-time Intra-operative Dosing of Methadone During Laparoscopic or Robotic Hysterectomy in Reducing Opioid Prescription
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
Currently there is a nationwide epidemic of opioid abuse and overdose deaths One source of excess opioids is overprescribing in the postoperative period This study aims to find the optimal pain medication plan during and after laparoscopic hysterectomy to eliminate long-term opioid use
Given the increasing opioid abuse and over-prescription post-operatively an effort should be made to determine whether one time dosing of Methadone a longer opioid analgesics intra-operatively is an adequate potential in treating postoperative pain after hysterectomy surgeries The investigators hypothesize that this could minimize the need for additional post-operative and outpatient opioid prescriptions and decrease the adverse effects that are associated with the consumption including new opioid abuse
Intervention group will receive methadone intraoperatively while the other group would receive short-acting opioids standard
Given the increasing opioid abuse and over-prescription post-operatively an effort should be made to determine whether one time dosing of Methadone a longer opioid analgesics intra-operatively is an adequate potential in treating postoperative pain after hysterectomy surgeries The investigators hypothesize that this could minimize the need for additional post-operative and outpatient opioid prescriptions and decrease the adverse effects that are associated with the consumption including new opioid abuse
Intervention group will receive methadone intraoperatively while the other group would receive short-acting opioids standard
Detailed Description:
Problem
The relief of moderate to severe postoperative pain in surgeries including abdominal surgeries continues to pose a major therapeutic dilemma The traditional and most common therapy is the administration of short-acting opioid analgesics intra-operative and post-operative at intervals every 3-4 hours However the use of opioids with relatively short plasma half-lives at varying intervals may lead to various fluctuating drug concentrations in plasma and side effects including respiratory longer hospitalizations delayed ambulation inadequate pain relief and potential avenues for abuse Identifying a more efficient and safer therapy for intraoperative pain analgesia can be helpful in controlling pain requirements in the post-operative setting
In major inpatient and ambulatory surgeries intraoperative single-dose methadone through its unique pharmacology has been shown to produce better analgesia reduce opioid use and minimize adverse side effects compared with conventional repeated dosing of short-duration opioids Additionally methadone is theorized to be an N-methyl-D-aspartate NMDA receptor noncompetitive antagonist which may contribute to its increase in analgesic potential as compared with fentanyl analogues Finally it has been shown to improve ambulation in the post operative anesthesia setting and pain control in chronic pain patients The study of intra-operative methadone has not been extensively studied for gynecology surgeries but one study has shown the decrease of mean opioid consumption post operatively after receiving one dose of intra-operative methadone compared to shorter acting opioids in same-day laparoscopic myomectomy Given the increasing opioid abuse and over-prescription post-operatively an effort should be made to determine whether one time dosing of longer opioid analgesics intra-operatively is an adequate potential in treating postoperative pain after hysterectomy surgeries and could minimize the need for additional post-operative and outpatient opioid prescriptions
This study aims at addressing the requirement for postoperative opioid prescription after intraoperative longer acting vs shorter acting opioids in laparoscopic hysterectomy
Hypothesis
Single dose of intra-operative methadone is an adequate potential in treating post-operative pain after laparoscopic total hysterectomy surgeries reducing the additional need for post-operative and outpatient opioid prescriptions and decreasing the adverse effects associated with opioid consumption
Importance of research
Given the increasing opioid abuse and over-prescription post-operatively an effort must be made to determine whether one time dosing of longer opioid analgesics intraoperatively in conjunction with non-opioid multimodal medications is adequate to treat postoperative pain after laparoscopic hysterectomy Additionally this intervention may decrease the need for additional prescriptions or unscheduled patient contacts
The relief of moderate to severe postoperative pain in surgeries including abdominal surgeries continues to pose a major therapeutic dilemma The traditional and most common therapy is the administration of short-acting opioid analgesics intra-operative and post-operative at intervals every 3-4 hours However the use of opioids with relatively short plasma half-lives at varying intervals may lead to various fluctuating drug concentrations in plasma and side effects including respiratory longer hospitalizations delayed ambulation inadequate pain relief and potential avenues for abuse Identifying a more efficient and safer therapy for intraoperative pain analgesia can be helpful in controlling pain requirements in the post-operative setting
In major inpatient and ambulatory surgeries intraoperative single-dose methadone through its unique pharmacology has been shown to produce better analgesia reduce opioid use and minimize adverse side effects compared with conventional repeated dosing of short-duration opioids Additionally methadone is theorized to be an N-methyl-D-aspartate NMDA receptor noncompetitive antagonist which may contribute to its increase in analgesic potential as compared with fentanyl analogues Finally it has been shown to improve ambulation in the post operative anesthesia setting and pain control in chronic pain patients The study of intra-operative methadone has not been extensively studied for gynecology surgeries but one study has shown the decrease of mean opioid consumption post operatively after receiving one dose of intra-operative methadone compared to shorter acting opioids in same-day laparoscopic myomectomy Given the increasing opioid abuse and over-prescription post-operatively an effort should be made to determine whether one time dosing of longer opioid analgesics intra-operatively is an adequate potential in treating postoperative pain after hysterectomy surgeries and could minimize the need for additional post-operative and outpatient opioid prescriptions
This study aims at addressing the requirement for postoperative opioid prescription after intraoperative longer acting vs shorter acting opioids in laparoscopic hysterectomy
Hypothesis
Single dose of intra-operative methadone is an adequate potential in treating post-operative pain after laparoscopic total hysterectomy surgeries reducing the additional need for post-operative and outpatient opioid prescriptions and decreasing the adverse effects associated with opioid consumption
Importance of research
Given the increasing opioid abuse and over-prescription post-operatively an effort must be made to determine whether one time dosing of longer opioid analgesics intraoperatively in conjunction with non-opioid multimodal medications is adequate to treat postoperative pain after laparoscopic hysterectomy Additionally this intervention may decrease the need for additional prescriptions or unscheduled patient contacts
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