Extrait

Background and study aims Breast cancer is the most common cancer in women that requires frequent surgery. Nearly 40% breast surgery patients experience significant amount of pain just after surgery, reflecting the inadequacy of conventional pain management.Most of the responses of the human body to post-surgical pain (pain after surgery) have been proven to be detrimental to the patient’s homeostasis (normal body function) and recovery. Furthermore, up to 50% of breast cancer patients suffer from chronic (long lasting) pain after surgery, and inadequate pain relief (analgesia) is considered to be a reason for this. A number of therapeutic measures have been accepted as a part of a “multi-modal” approach to postoperative pain control. Thoracic paravertebral block (PVB) is used for pain relief after chest (thoracotomy) surgery and mastectomy (removal of the breast). PVB can provide profound, long-lasting deafferentation (blocking or destroying nerve cells that cause pain). Unlike general anesthesia, PVB can provide postoperative analgesia which much more effective than other forms of pain relief. It can also lead to less nausea and vomiting, a shorter recovery time, and earlier discharge from hospital. The use of PVB in patients undergoing ambulatory (outpatient) breast surgery has a cost-saving potential. Fentanyl is a synthetic (man-made) opioid with a short-acting pain killing effect that is suitable to be applied directly to the skin. The aim of this study is to study the effect of transdermal fentanyl (that is, fentanyl given though the skin) via a method called the transdermal therapeutic system (TTS). The aim of this study is to investigate the effect of transdermal fentanyl as adjuvant to paravertebral block for pain control in breast cancer surgery.   Who can participate? Women with breast cancer scheduled for surgery. What does the study involve? Participants are randomly allocated to one of two groups. Those in group 1 are given a Patients will be randomly classified using sealed envelope into two equal groups each of 25transdermal fentanyl (TDF) patch three hours before their operation. Paravertebral block (PVB) is also be performed before the patient is given general anesthesia. Those in group 2 are given the PVB only. Heart rate and blood pressure are monitored before and during surgery.After surgery patients are transferred to the post-anesthesia care unit (PACU) and are monitored for vital signs, level of sedation and pain. What are the possible benefits and risks of participating? Not provided at time of registration Where is the study run from? National Cancer Institute, Cairo University When is the study starting and how long is it expected to run for? March 2016 to June 2016 Who is funding the study? National Cancer Institute, Cairo University Who is the main contact? Dr Ahmed Bakir [email protected]

Critère d'inclusion

• Postoperative pain (breast cancer patients)

Liens

• isrctn
• ictrp