Lidocaine 5% Patch (Lidoderm) for the Prevention of Acute and Chest Pain Following Robotic Valve Surgery

Brief summary (from the registry)

The post-thoracotomy pain (PTP) has been defined as persistent or recurrent pain that lasts for at least 2 month after thoracotomy and is associated with surgical incision or its intercostal nerve cutaneous distribution. The latter has a prevalence of about 15% to 20%. In about 80% of the patients such pain is moderate to severe in intensity and is associated with depression and insomnia. According to its characteristics and possible etiology, PTP is part of the neuropathic pain syndromes. Patients describe their chest wall pain as shooting, burning and numbness which are descriptors often seen in other neuropathic pain syndromes. PTP occurs most likely after partial or complete intercostal nerve damage secondary mechanical trauma (nerve traction or compression) during surgery. The concern is that when robotic surgery for minimally invasive approach to the heart valves or vessels such compression and consequent damage may happen to intercostal nerves. Therapeutic use for a lidocaine patch include post-herpetic neuralgia postthoracotomy pain, stump neuroma pain, intercostal neuralgia, diabetic polyneuropathy, meralgia paresthetica, complex regional pain syndrome, radiculopathy, postmastectomy pain and some other focal peripheral neuropathic pain syndromes. It is an effective and safe topical treatment. Its efficacy demonstrated previously in treatment of intercostal neuralgia and some patients with post-thoracotomy syndrome can be used in treatment of perioperative chest pain related to robotic cardiac surgery. Hypothesis is that the use of topical lidocaine will decrease pain in acute phase after the surgery and decrease intensity of post-thoracotomy pain 6 months after such procedure. The effect of topical 5% lidocaine will be clinically evaluated through prospective, randomized, placebo, double-blind study. Each patient will be assessed at admission and then, one week after Valve Replacement (Recommended surgical procedures do not included harvesting of leg vessel…

Study details

Official title

Lidocaine 5% Patch (Lidoderm) for the Perioperative Prevention of Acute and Chronic Chest Pain Following Robotic Valve Surgery

Conditions

• Perioperative Chest Pain

Interventions

• Drug: Lidoderm 5 % Topical Patch
• Drug: Placebo patch

Sponsor

The Cleveland Clinic

Collaborators

Endo USA Inc., a Keenova Therapeutics Company

Start date

2009-09

Primary completion

2011-04

Sex

All

Age range

from 18 Years

Results posted

Yes, on ClinicalTrials.gov

Countries

United States

Total sites listed

1

Eligibility criteria