An interventional study of Lidoderm 5 % Topical Patch and Placebo patch in Perioperative Chest Pain, sponsored by The Cleveland Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-17.
Sponsored by The Cleveland Clinic · Not applicable, Interventional, and Treatment
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 vessels as this could be a potential confounder). Then, one month, three and six month follow-up for all patients by mailing questionnaires and phone calls.
Upon admission, as well as 1 week, 1month, 3months and 6 months following surgical procedure, the following tests will be performed:
381 studies on the registry are indexed under Chest Pain; 66 are open to participants now.
This study's enrollment of 80 is below the median of 143 across 201 interventional studies indexed under Chest Pain.
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Exclusion Criteria:
Patient will be excluded from this study if they meet any of the following criteria:
1) Group I: Patients will receive topical 5% lidocaine patches. Those will be placed to affected area up to three patches as needed for pain 12 hours on and 12 hours off. They will also receive opioids as needed after the surgery. Initially, they may receive IV fentanyl repeated clinician boluses, later oxycodone will be given 5-10 mg q4-6 hours as needed for pain.
Drug: Lidoderm 5 % Topical Patch
2) Group II: Patients will receive placebo patches. Those will be placed to affected area at dose up to three patches as needed for pain 12 hours on and 12 hours off. They will also receive opioids as needed after the surgery. Initially, they may receive IV fentanyl clinician boluses, later oxycodone will be given in doses from 5-10 mg q4-6 hours as needed for pain.
Drug: Placebo patch
Patients will receive Lidoderm topical 5% lidocaine patches. Those will be placed to affected area up to three patches as needed for pain 12 hours on and 12 hours off
Also known as: Lidoderm
2) Group II: Patients will receive placebo patches. Those will be placed to affected area at dose up to three patches as needed for pain 12 hours on and 12 hours off
Pain Disability Index Score (PDI) at Six Months Following Surgical Procedure
Pain Disability Index score (PDI) ranges from 0 to 70, with higher scores reflecting higher interference of pain with daily activities.
Time frame: After surgery until postoperative day 7, 30, 90 and 180
80 Enrolled
| Milestone | LIDOCAINE PATCH 5% | Placebo Patch |
|---|---|---|
| Started | 40 | 40 |
| Completed | 39 | 39 |
| Not completed | 1 | 1 |
| Withdrew: Physician decision | 1 | 1 |
Pain Disability Index score (PDI) ranges from 0 to 70, with higher scores reflecting higher interference of pain with daily activities.
| units on a scale | LIDOCAINE PATCH 5% | Placebo Patch |
|---|---|---|
| PDI on postoperative day 7 | 26 ± 17 | 30 ± 19 |
| PDI on postoperative day 30 | 12 ± 14 | 13 ± 16 |
| PDI on postoperative day 90 | 3.2 ± 7.8 | 5.0 ± 13.3 |
| PDI on postoperative day 180 | 1.7 ± 6.4 | 4.8 ± 15.5 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| LIDOCAINE PATCH 5% | 0/39 (0%) | 0/39 (0%) | 3/39 (7.7%) |
| Placebo Patch | 0/39 (0%) | 0/39 (0%) | 2/39 (5.1%) |
| Event | LIDOCAINE PATCH 5% | Placebo Patch |
|---|---|---|
| confusionNervous system disorders | — | — |
| Event | LIDOCAINE PATCH 5% | Placebo Patch |
|---|---|---|
| ConfusionNervous system disorders | 1/39 | 0/39 |
| atrial arrhythmiaCardiac disorders | 1/39 | 0/39 |
| neurological deficitNervous system disorders | 1/39 | 0/39 |
| Ches wall herniaGeneral disorders | 0/39 | 1/39 |
| Pleural effusionGeneral disorders | 0/39 | 1/39 |
| Age, Continuous(years) | LIDOCAINE PATCH 5% | Placebo Patch | Total |
|---|---|---|---|
| Mean | 56 ± 11 | 58 ± 10 | 57 ± 10 |
| Sex: Female, Male(Participants) | LIDOCAINE PATCH 5% | Placebo Patch | Total |
|---|---|---|---|
| Female | 8 | 10 | 18 |
| Male | 31 | 29 | 60 |
| Body mass index(kg/m2) | LIDOCAINE PATCH 5% | Placebo Patch | Total |
|---|---|---|---|
| Mean | 26 ± 4 | 25 ± 4 | 26 ± 4 |
| Systolic blood pressure(mmHg) | LIDOCAINE PATCH 5% | Placebo Patch | Total |
|---|---|---|---|
| Mean | 125 ± 16 | 126 ± 14 | 126 ± 15 |
| Diastolic blood pressure(mmHg) | LIDOCAINE PATCH 5% | Placebo Patch | Total |
|---|---|---|---|
| Mean | 72 ± 12 | 70 ± 10 | 71 ± 11 |
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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