Pain Management Following TRAM Flap for Breast Reconstruction

2014-08-27 03:37:23 | BioPortfolio


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.


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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Breast Cancer


Saline, Bupivicaine


U.T.M.D. Anderson Cancer Center
United States




M.D. Anderson Cancer Center

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:37:23-0400

Clinical Trials [4784 Associated Clinical Trials listed on BioPortfolio]

Stellate Ganglion Block (SGB) For Women for Breast Cancer

Vasomotor symptoms (VMS) affect up to 65% of breast cancer survivors and negatively impact their quality of life. The investigators aim to evaluate the benefit of SGB in symptomatic women ...

Effects of Stellate Ganglion Block on Hot Flashes in Hispanic Women With Breast Cancer

Vasomotor symptoms (hot flashes, night sweats, VMS) affect up to 65% of breast cancer survivors and negatively impact their quality of life. VMS in Hispanic women are significantly more se...

Effects of Dexmedetomidine on Breast Cancer Cell Function in Vitro

Dexmedetomidine is widely used as an anaesthetic for general anesthesia during surgery. Previous studies in cells and animals show that dexmedetomidine may promote cancer growth. Using ser...

Neurovascular Changes Induced by Chemotherapy

The purpose of the present study was to test the hypothesis that doxorubicin and cyclophosphamide adjuvant chemotherapy (CHT) acutely induces neurovascular and hemodynamic changes in patie...

Efficacy of EUS-Guided Celiac Plexus Blockade in Chronic Pancreatitis

This is a triple-blind, parallel group, randomized controlled trial to assess the benefit of triamcinolone injection as a therapeutic measure for control of chronic pancreatitis pain. The ...

PubMed Articles [14869 Associated PubMed Articles listed on BioPortfolio]

Adult weight change and the risk of pre- and postmenopausal breast cancer in the Chinese Wuxi Exposure and Breast Cancer Study.

The accumulating evidence indicates that weight gain in adulthood is more predictive of breast cancer risk than absolute body weight. However, the relative impact of timing of weight gain in adulthood...

The Significance of the Stromal Response in Breast Cancer: An Immunohistochemical Study of Myofibroblasts in Primary and Metastatic Breast Cancer.

Gene expression profiling of breast cancer has demonstrated the importance of stromal response in determining the prognosis of invasive breast cancer. The host response to breast cancer is of increasi...

Urinary Phthalate Metabolite Concentrations and Breast Cancer Incidence and Survival following Breast Cancer: The Long Island Breast Cancer Study Project.

Phthalates, known endocrine disruptors, may play a role in breast carcinogenesis. Few studies have examined phthalates in relation to breast cancer (BC), and, to our knowledge, none have considered su...

Trends in Breast Cancer Mortality by Stage at Diagnosis Among Young Women in the United States.

Assessing trends in breast cancer survival among young women who are largely unaffected by breast cancer screening will provide important information regarding improvements in the effectiveness of can...

Localized morphea after breast implant for breast cancer: A case report.

Early breast cancer follow-up guidelines for patients who underwent surgery suggest a regular and accurate clinical examination of the breast area, for an early identification of cutaneous or subcutan...

Medical and Biotech [MESH] Definitions

Abnormal accumulation of lymph in the arm, shoulder and breast area associated with surgical or radiation breast cancer treatments (e.g., MASTECTOMY).

Metastatic breast cancer characterized by EDEMA and ERYTHEMA of the affected breast due to LYMPHATIC METASTASIS and eventual obstruction of LYMPHATIC VESSELS by the cancer cells.

A infiltrating (invasive) breast cancer, relatively uncommon, accounting for only 5%-10% of breast tumors in most series. It is often an area of ill-defined thickening in the breast, in contrast to the dominant lump characteristic of ductal carcinoma. It is typically composed of small cells in a linear arrangement with a tendency to grow around ducts and lobules. There is likelihood of axillary nodal involvement with metastasis to meningeal and serosal surfaces. (DeVita Jr et al., Cancer: Principles & Practice of Oncology, 3d ed, p1205)

A deoxycytidine derivative and fluorouracil PRODRUG that is used as an ANTINEOPLASTIC ANTIMETABOLITE in the treatment of COLON CANCER; BREAST CANCER and GASTRIC CANCER.

Carbohydrate antigen elevated in patients with tumors of the breast, ovary, lung, and prostate as well as other disorders. The mucin is expressed normally by most glandular epithelia but shows particularly increased expression in the breast at lactation and in malignancy. It is thus an established serum marker for breast cancer.

More From BioPortfolio on "Pain Management Following TRAM Flap for Breast Reconstruction"

Quick Search


Relevant Topics

Pain is defined by the International Association for the Study of Pain as “an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage”. Some illnesses can be excruci...

Prostate Cancer
Prostate cancer (cancer de prostata) Prostate cancer (cancer de prostata) is a form of cancer that develops in the prostate, a gland in the male reproductive system. Most prostate cancers are slow growing; however, there are cases of aggressive prostat...

Searches Linking to this Trial