Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00500565
Status:
COMPLETED
Last Update Posted:
2013-10-11
First Post:
2007-07-10
Brief Title:
Pain Management Following TRAM Flap for Breast Reconstruction
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Randomized Double Blind Controlled Trial of Two Methods of Postoperative Pain Management Following Free Transverse Rectus Abdominous Musculocutaneous TRAM Flap for Breast Reconstruction
Status:
COMPLETED
Status Verified Date:
2013-10
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:
The objective of this pilot study is to examine the efficacy of the ONQ Pain Relief System plus Intravenous Patient Controlled Analgesia IVPCA with Morphine vs IV PCA alone in patients undergoing free transverse rectus abdominis musculocutaneous TRAM flap surgery The primary outcome measure will be postoperative opioid analgesia requirements Other outcomes will also be assessed including pain scores quality of recovery and resource utilization
Detailed Description:
Inadequate control of surgical pain after free TRAM procedures may lead to complications and delay recovery time This could lead to a longer stay in the hospital The standard care for pain after a free TRAM procedure has been with drugs that are anesthetics Unfortunately these anesthetics are not long lasting and usually require the use of opioids morphine or hydromorphone to control break-through pain A continuous delivery of local anesthetic to the wound site may provide better control of pain and decrease the need for the use of opioids This may decrease the length of the hospital stay as well as other side effects associated with the treatment of pain
Before the study you will be asked questions about your health your age and about any allergies you may have Women who are able to have children must have a negative blood pregnancy test You will have already been scheduled to undergo a free TRAM flap procedure
During free TRAM flap procedure you will have two soaker catheters placed by the surgeon directly into the surgical site The catheters are flexible tubes which will allow pain medicine or saline to be delivered directly to the donor wound site which is the abdominal site from where the tissue for breast reconstruction is taken A small pump On-Q pump will be connected to the catheter to deliver a constant flow of pain medicine or saline for up to 5 days The On-Q pump is completely portable and can be attached to your hospital gown to allow for movement
You will be randomly assigned as in the toss of a coin to one of two groups Participants in the first group will have the On-Q pump filled with saline Participants in the other group will have the On-Q pump filled with bupivicaine
Participants in both groups will receive IVPCA which is the standard of care for pain relief The IVPCA will be placed on PRN mode which means you will be able to press a button to deliver pain medication whenever you feel pain
You will be asked questions about your pain and your recovery process every 6 hours while you are awake for up to 5 days You will also be asked to fill out a questionnaire about pain once a day during treatment It should take around 10 minutes to complete the questionnaire
The catheters will be removed after 5 days of treatment or your last day in the hospital whichever is sooner by one of the surgeons that participated in the surgery
During the study if you experience any intolerable side effects or your doctor feels it is in your best interest to stop treatment you will be taken off the study and other treatment options will be discussed with you
This is an investigational study The On-Q device PCA and bupivicaine are FDA approved and commercially available Up to 60 participants will take part in this study 30 in each group All will be enrolled at The University of Texas UT MD Anderson Cancer Center MDACC
This protocol is partially funded by a research grant from the I-Flow Corporation
Before the study you will be asked questions about your health your age and about any allergies you may have Women who are able to have children must have a negative blood pregnancy test You will have already been scheduled to undergo a free TRAM flap procedure
During free TRAM flap procedure you will have two soaker catheters placed by the surgeon directly into the surgical site The catheters are flexible tubes which will allow pain medicine or saline to be delivered directly to the donor wound site which is the abdominal site from where the tissue for breast reconstruction is taken A small pump On-Q pump will be connected to the catheter to deliver a constant flow of pain medicine or saline for up to 5 days The On-Q pump is completely portable and can be attached to your hospital gown to allow for movement
You will be randomly assigned as in the toss of a coin to one of two groups Participants in the first group will have the On-Q pump filled with saline Participants in the other group will have the On-Q pump filled with bupivicaine
Participants in both groups will receive IVPCA which is the standard of care for pain relief The IVPCA will be placed on PRN mode which means you will be able to press a button to deliver pain medication whenever you feel pain
You will be asked questions about your pain and your recovery process every 6 hours while you are awake for up to 5 days You will also be asked to fill out a questionnaire about pain once a day during treatment It should take around 10 minutes to complete the questionnaire
The catheters will be removed after 5 days of treatment or your last day in the hospital whichever is sooner by one of the surgeons that participated in the surgery
During the study if you experience any intolerable side effects or your doctor feels it is in your best interest to stop treatment you will be taken off the study and other treatment options will be discussed with you
This is an investigational study The On-Q device PCA and bupivicaine are FDA approved and commercially available Up to 60 participants will take part in this study 30 in each group All will be enrolled at The University of Texas UT MD Anderson Cancer Center MDACC
This protocol is partially funded by a research grant from the I-Flow Corporation
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