Posted by on Feb 3, 2018 in Breast cancer | 0 comments

In a nutshell

This trial is examining the effectiveness of pulsed electromagnetic field (PEMF) or an anesthetic bupivacaine in lowering the incidence of chronic pain after surgery. The main outcome to be measured will be the incidence of chronic pain after each treatmentThis study is being conducted in New York City. 

The details

Chronic pain can occur after mastectomy, or breast tissue removal. Almost half of women experience this. Poor pain control can lead to a higher incidence of chronic pain and delayed wound healing. There are two methods of pain control during surgery, one that uses pulsed electromagnetic field (PEMF) and a device is placed over dressings at the surgical site. The second type is a pain block where a long lasting anesthetic bupivacaine is injected into the area. Both of these are effective but they have not been compared to each other in terms of effectiveness. 

The main outcome to be measured in this study will be the incidence of chronic pain after pulsed electromagnetic field (PEMF) or an anesthetic bupivacaine. The secondary outcome is the quality of recovery. 

Who are they looking for?

This study will recruit 60 women planning to undergo mastectomy. 

Patients should not have a narcotic allergy or take chronic opioids before surgery. 

How will it work

There will be four groups in this trial. Patients will be randomly allocated to 1) active PEMF and active bupivacaine, 2) active PEMF and placebo (substance with no active effect) drug, 3) placebo PEMF and bupivacaine or 4) placebo PEMF and placebo drug. 

Pain scores and quality scores will be followed up via questionnaire for two years after surgery. 

Clinical trial locations

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Type:Interventional
Participants:60
Study ID:NCT03360214
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