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NCT03120351 · ClinicalTrials.gov registry record · NA
Lidocaine 5% Patch (Lidoderm) for the Prevention of Acute and Chest Pain Following Robotic Valve Surgery
A NA study, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- NA
- Development phase
- 80
- Enrollment target
NCT03120351: Completed NA study, sponsored by The Cleveland Clinic.
NCT03120351 is a NA study that has completed, run by The Cleveland Clinic. The registered enrollment target is 80 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03120351, a NA study, has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- NA
- Development phase
- 80 participants
- Enrollment target
Study Summary
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 vess
Primary Outcome
Pain Disability Index score (PDI) ranges from 0 to 70, with higher scores reflecting higher interference of pain with daily activities.
Interventions
- DRUG Placebo patch
- DRUG Lidoderm 5 % Topical Patch
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2009-09 |
| Est. Completion | 2011-04 |
| Phase | NA |
What the finished NCT03120351 record still lists
NCT03120351 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo patch is the first listed.
NCT03120351 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03120351 about?
NCT03120351 is a clinical study titled "Lidocaine 5% Patch (Lidoderm) for the Prevention of Acute and Chest Pain Following Robotic Valve Surgery". 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 s...
What is the current status of trial NCT03120351?
This trial is currently completed. It is a NA study. The enrollment target is 80 participants. The study started on 2009-09. Estimated completion is 2011-04.
What interventions are being tested in trial NCT03120351?
The interventions under investigation include: Placebo patch (DRUG), Lidoderm 5 % Topical Patch (DRUG).
Who is sponsoring clinical trial NCT03120351?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03120351's enrollment target sits among peer trials
80 994th of 2000 higher than 941 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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