Ignite Creation Date:
2024-05-05 @ 6:44 PM
Last Modification Date:
2024-10-26 @ 9:36 AM
Study NCT ID:
NCT00533845
Status:
COMPLETED
Last Update Posted:
2019-04-16
First Post:
2007-09-20
Brief Title:
Intraperitoneal Bupivicaine Infusion Using the On-Q Pain Pump After Laparoscopic Surgery
Sponsor:
Maimonides Medical Center
Organization:
Maimonides Medical Center
Study Overview
Official Title:
Intraperitoneal Bupivicaine Infusion Using the On-Q Pain Pump After Laparoscopic Surgery
Status:
COMPLETED
Status Verified Date:
2019-04
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:
After Laparoscopic surgery most patients experience some form of mild to moderate pain The current standard of care is to treat this pain with local anesthetics numbing medication that deadens the nerve endings to the small surgical incisions cuts and narcotic systemic analgesics medication injected into your vein to control pain such as morphine
Although this treatment improves pain symptoms it is not perfect Firstly complete pain control is rarely achieved and secondly narcotics such as morphine often have many side effects including nausea vomiting sedation sleepiness constipation and abdominal upset All of these issues make recovery less comfortable and delays return to full function work school and other activities of daily life
A new FDA approved device is now available that offers the benefits of long term anesthesia without the side effects of narcotics It consists of a pump that continuously infuses local anesthesia into and around the surgical site This pump is placed during your operation You then carry a tennis ball sized container made of soft plastic in a pouch which drips numbing medicine around your wounds for 2 days continuously
The purpose of this study is to see if this pump improves postoperative pain decreases the need for narcotic pain medicine and allows people to return to their activities earlier
Although this treatment improves pain symptoms it is not perfect Firstly complete pain control is rarely achieved and secondly narcotics such as morphine often have many side effects including nausea vomiting sedation sleepiness constipation and abdominal upset All of these issues make recovery less comfortable and delays return to full function work school and other activities of daily life
A new FDA approved device is now available that offers the benefits of long term anesthesia without the side effects of narcotics It consists of a pump that continuously infuses local anesthesia into and around the surgical site This pump is placed during your operation You then carry a tennis ball sized container made of soft plastic in a pouch which drips numbing medicine around your wounds for 2 days continuously
The purpose of this study is to see if this pump improves postoperative pain decreases the need for narcotic pain medicine and allows people to return to their activities earlier
Detailed Description:
The procedure of the current study is to randomly assign patients undergoing minimally invasive surgeries laparoscopic cholecystectomies and laparoscopic Lap-Banding procedures to one of two groups Both groups will have the standard surgical procedure performed and then at the completion will have the on-Q system placed in a subdiaphragmatic within the abdomen location Half of the study group will have bupivicaine a numbing medicine in the pump while the other half will have sterile saline in their pump Neither the patient nor the surgeon will be aware of which group any particular patient is in this is a process known as blinding and improves the reliability of the results All patients will receive the standard locally infiltrated trocar site local anesthetic and either a prescription for Vicodin for ambulatory patients or morphine injected into their vein for patients staying in the hospital
All patients will then be asked at preset intervals their level of pain the presence of nausea and their need for Vicodin or morphine Ambulatory patients will be reached by phone for answers to these questions All patients will have their pain controlled in the usual and standard way at all times The On-Q pump will be removed at 48hours
The results will then be statistically reviewed to see if the On-Q pumps were of benefit
All patients will then be asked at preset intervals their level of pain the presence of nausea and their need for Vicodin or morphine Ambulatory patients will be reached by phone for answers to these questions All patients will have their pain controlled in the usual and standard way at all times The On-Q pump will be removed at 48hours
The results will then be statistically reviewed to see if the On-Q pumps were of benefit
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