Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00286286
Status:
UNKNOWN
Last Update Posted:
2007-01-11
First Post:
2006-02-01
Brief Title:
Intraperitoneal Aerosolized Delivery of a Local Anesthetic for Post Operative Pain Management A Double Blind Randomised Controlled Clinical Trial
Sponsor:
Northgate Technologies
Organization:
Northgate Technologies
Study Overview
Official Title:
Clinical Protocol for the Prospective Double Blind Randomised Controlled Trial for the Use of Intraperitoneal Aerosolized Local Anesthetic
Status:
UNKNOWN
Status Verified Date:
2007-01
Last Known Status:
ACTIVE_NOT_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 purpose of this study is to determine the effectiveness of aerosolized pain medication 5 bupivicaine delivered into the peritoneal cavity after laparoscopic gastric bypass surgery This double blind study will include 50 patients 25 will receive the aerosolized pain medication and 25 will receive a placebo normal saline All 50 patients will receive routinetypical methods of post-operative pain management Post operative pain scores of the patients will be examined to determine the effect of aerosolization
Detailed Description:
Surgical Technique
1 30 mls of 05 bupivacaine with epinephrine standard dose will be distributed into the trocar site wounds after desufflation of the peritoneal cavity
2 All the patients will be under a consistent intra-abdominal pressure using CO2 and the laparoscopy will be carried out using the same routine typical surgical instruments
A Control Group n25 Aerosolized normal saline will be introduced at the end of the procedure using a specially designed sterile catheter The catheter will be inserted via trocar port under direct vision The other end of the catheter will be connected to a 72 Edwards Lifesciences pressure tubing Ref 50P172 which will be connected to a BD 20cc syringe filled with 15 ml of normal saline and inserted into a specially designed syringe pump and pressurizing system designed to aerosolize the specified agent The total dose of patient delivered normal saline will be 10 ml with 5 ml remaining contained and undelivered within the catheter and 72 pressure tubing RoutineTypical methods of post-operative pain management will be employed
B Aerosolized anesthetic n25 at the end of the procedure the aerosolized local anesthetic will be introduced using a specially designed sterile catheter The catheter will be inserted via trocar port under direct vision The other end of the catheter will be connected to a 72 Edwards Lifesciences pressure tubing Ref 50P172 which will be connected to a BD 20cc syringe filled with 15 ml of anesthetic agent and inserted into a specially designed syringe pump and pressurizing system designed to aerosolize the specified agent The total dose of patient delivered anesthetic will be 10 ml with 5 ml remaining contained and undelivered within the catheter and 72 pressure tubing RoutineTypical methods of post-operative pain management will be employed
1 30 mls of 05 bupivacaine with epinephrine standard dose will be distributed into the trocar site wounds after desufflation of the peritoneal cavity
2 All the patients will be under a consistent intra-abdominal pressure using CO2 and the laparoscopy will be carried out using the same routine typical surgical instruments
A Control Group n25 Aerosolized normal saline will be introduced at the end of the procedure using a specially designed sterile catheter The catheter will be inserted via trocar port under direct vision The other end of the catheter will be connected to a 72 Edwards Lifesciences pressure tubing Ref 50P172 which will be connected to a BD 20cc syringe filled with 15 ml of normal saline and inserted into a specially designed syringe pump and pressurizing system designed to aerosolize the specified agent The total dose of patient delivered normal saline will be 10 ml with 5 ml remaining contained and undelivered within the catheter and 72 pressure tubing RoutineTypical methods of post-operative pain management will be employed
B Aerosolized anesthetic n25 at the end of the procedure the aerosolized local anesthetic will be introduced using a specially designed sterile catheter The catheter will be inserted via trocar port under direct vision The other end of the catheter will be connected to a 72 Edwards Lifesciences pressure tubing Ref 50P172 which will be connected to a BD 20cc syringe filled with 15 ml of anesthetic agent and inserted into a specially designed syringe pump and pressurizing system designed to aerosolize the specified agent The total dose of patient delivered anesthetic will be 10 ml with 5 ml remaining contained and undelivered within the catheter and 72 pressure tubing RoutineTypical methods of post-operative pain management will be employed
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