Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00280553
Status:
UNKNOWN
Last Update Posted:
2012-05-15
First Post:
2006-01-19
Brief Title:
A Pilot Study of Bupivacaine Infusion in Abdominal Surgery
Sponsor:
Margherita CADDEDU
Organization:
McMaster University
Study Overview
Official Title:
A Pilot Study of Bupivacaine Infusion in Abdominal Surgery
Status:
UNKNOWN
Status Verified Date:
2012-05
Last Known Status:
RECRUITING
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:
The incisions used in abdominal surgery can be quite painful requiring strong pain medications A new pain pump that trickles small amounts of local freezing into the incision has been developed that helps numb the area so that the patient does not feel the pain for two to five days after surgery
The main research question is whether use of the pain pump will result in decreased hospital length of stay The research is important because if the pain pump is found to be effective it can substantially decrease the length of stay Areas to be studied include hospital length of stay patients comfort post-operatively and post-operative complications
The main research question is whether use of the pain pump will result in decreased hospital length of stay The research is important because if the pain pump is found to be effective it can substantially decrease the length of stay Areas to be studied include hospital length of stay patients comfort post-operatively and post-operative complications
Detailed Description:
Pain in the post-operative period has been a limiting factor delaying recovery following abdominal surgery Furthermore it has been associated with several complications including ileus urinary retention delay to tolerating oral intake and enteral feeds thrombo-embolic complications and respiratory complications such as atelectasis and pneumonia Diminishing pain in the post-operative period has been a subject of great study and to date the role of epidural analgesia epidural anesthesia patient controlled anesthesia and narcotic analgesia has been well documented to assist in controlling pain decreasing morbidity and accelerating recovery in the post-operative period following colorectal surgery
Nevertheless the use of opioid-based analgesic techniques via epidural nurse or patient controlled delivery systems either oral or parenteral can produce adverse effects such as nausea vomiting ileus delay in tolerance or urinary retention Concomitant use of non-narcotic based analgesics have failed to obviate the need for narcotic based analgesia Recently several companies have developed devices that deliver a constant rate of local anesthetic via a spring loaded device through a multiport catheter inserted into the incision The effectiveness of these bupivicaine infusion pumps has been demonstrated to diminish post-operative pain following orthopedic plastic thoracic and cardiac surgeries but to date their role has not been evaluated in colorectal surgery or abdominal surgery
The rational of the study is that bupivicaine infusion pumps are being used at St Josephs Healthcare for patients undergoing laparoscopic assisted colorectal surgery and anecdotally the patients have less pain need less narcotics and can ambulate and be discharged sooner This pilot study aims to gather prospective randomized data regarding post-operative length of stay and patient pain scores so that a properly powered randomization study can be undertaken to understand if the bupivicaine infusion system helps decrease length of stay and patients post-operative pain
Nevertheless the use of opioid-based analgesic techniques via epidural nurse or patient controlled delivery systems either oral or parenteral can produce adverse effects such as nausea vomiting ileus delay in tolerance or urinary retention Concomitant use of non-narcotic based analgesics have failed to obviate the need for narcotic based analgesia Recently several companies have developed devices that deliver a constant rate of local anesthetic via a spring loaded device through a multiport catheter inserted into the incision The effectiveness of these bupivicaine infusion pumps has been demonstrated to diminish post-operative pain following orthopedic plastic thoracic and cardiac surgeries but to date their role has not been evaluated in colorectal surgery or abdominal surgery
The rational of the study is that bupivicaine infusion pumps are being used at St Josephs Healthcare for patients undergoing laparoscopic assisted colorectal surgery and anecdotally the patients have less pain need less narcotics and can ambulate and be discharged sooner This pilot study aims to gather prospective randomized data regarding post-operative length of stay and patient pain scores so that a properly powered randomization study can be undertaken to understand if the bupivicaine infusion system helps decrease length of stay and patients post-operative pain
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