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| Sponsors and Collaborators: |
M.D. Anderson Cancer Center I-Flow |
|---|---|
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00500565 |
Purpose
The objective of this pilot study is to examine the efficacy of the ON~Q 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.
| Condition | Intervention |
|---|---|
|
Breast Cancer |
Drug: Saline Drug: Bupivicaine |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 60 |
| Study Start Date: | December 2003 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1 with Saline: Experimental
On-Q Pump with Saline
|
Drug: Saline
On-Q Pain Pump filled with Saline. The On-Q pump will be connected to the catheter to deliver a constant flow of saline for up to 5 days.
|
|
2 with Bupivicaine: Experimental
On-Q Pump with bupivicaine
|
Drug: Bupivicaine
On-Q Pain Pump filled with 0.375% Bupivicaine through two catheters at a total rate of 4 cc/hr over 111 hours. The On-Q pump will be connected to the catheter to deliver a constant flow of Bupivicaine for up to 5 days.
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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 UTMDACC.
This protocol is partially funded by a research grant from the I-Flow Corporation.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| U.T.M.D. Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Charles E. Butler, MD | U.T.M.D. Anderson Cancer Center |
More Information
| Responsible Party: | U.T.M.D. Anderson Cancer Center ( Charles E. Butler, MD/Associate Professor ) |
| Study ID Numbers: | ID03-0046 |
| Study First Received: | July 10, 2007 |
| Last Updated: | June 12, 2008 |
| ClinicalTrials.gov Identifier: | NCT00500565 |
| Health Authority: | United States: Institutional Review Board |
|
Breast Cancer On-Q Pain Relief System Transverse Rectus Abdominous Myocutaneous Breast Reconstruction |
TRAM flap Bupivicaine Pain Management |
|
Skin Diseases Breast Neoplasms Bupivacaine |
Pain Breast Diseases Pain, Postoperative |
|
Neoplasms Neoplasms by Site Sensory System Agents Therapeutic Uses Physiological Effects of Drugs Central Nervous System Depressants |
Anesthetics Peripheral Nervous System Agents Central Nervous System Agents Pharmacologic Actions Anesthetics, Local |
