Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06458842
Status:
TERMINATED
Last Update Posted:
2024-06-14
First Post:
2024-05-17
Brief Title:
Postoperative Pain Protocol Limiting Narcotics for Laparoscopic Hand-assisted Donor Nephrectomy
Sponsor:
Stony Brook University
Organization:
Stony Brook University
Study Overview
Official Title:
Postoperative Pain Protocol Limiting Narcotics for Laparoscopic Hand-assisted Donor Nephrectomy Patients A Randomized Control Trial
Status:
TERMINATED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to recruit desired number of patients in reasonable time frame
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Kidney donors represent healthy patients and their anticipated postoperative course should be uncomplicated and brief This study looks to optimize the perioperative pain regimen of laparoscopic donor nephrectomy patients by minimizing or eliminating narcotics from the immediate post-operative period Current postoperative standard of care after donor nephrectomy require narcotic analgesics While narcotics are potent pain medications they are often associated with complications including nausea vomiting and dysfunction of the gastrointestinal tract causing prolonged complications
The investigators seek to evaluate a peri-operative pain regimen limiting the usage of narcotics This incorporates a perioperative analgesic course utilizing combination of an intravenous non-steroidal anti-inflammatory drug NSAID intravenous acetaminophen and intravenous ketamine All three have been demonstrated to be effective for the control of perioperative pain while decreasing narcotics use
Prior to surgery participants will be consented and randomly assigned to receive the standard of care perioperative pain management using intravenous narcotics as a patient-controlled analgesia PCA by itself plus placebo or along with the new protocol The study will demonstrate it the new protocol will limit or eliminate the need for narcotics as a patient-controlled dose during the postoperative period
Upon discharge from the hospital patients will be followed in clinic and via home questionnaires annually for 5 years to evaluate satisfaction renal function and quality of life
The investigators seek to evaluate a peri-operative pain regimen limiting the usage of narcotics This incorporates a perioperative analgesic course utilizing combination of an intravenous non-steroidal anti-inflammatory drug NSAID intravenous acetaminophen and intravenous ketamine All three have been demonstrated to be effective for the control of perioperative pain while decreasing narcotics use
Prior to surgery participants will be consented and randomly assigned to receive the standard of care perioperative pain management using intravenous narcotics as a patient-controlled analgesia PCA by itself plus placebo or along with the new protocol The study will demonstrate it the new protocol will limit or eliminate the need for narcotics as a patient-controlled dose during the postoperative period
Upon discharge from the hospital patients will be followed in clinic and via home questionnaires annually for 5 years to evaluate satisfaction renal function and quality of life
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?:
None