Perioperative Chest Pain
Conditions
Brief 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 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: * Pain Disability Index (PDI) * DASS * VAS Pain Score * Opioid use (in MSO4 mg equivalents) * Global Perceived Effect (GPE) or patient satisfaction
Interventions
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
DRUGPlacebo 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
Sponsors
Endo Pharmaceuticals
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double-blind
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* consenting patients ≥ 18 years of age * scheduled for robotic heart surgery
Exclusion criteria
Patient will be excluded from this study if they meet any of the following criteria: * Patients with a history of mental instability or diagnosed with a mental disorder (e.g. Depression, Somatoform Conversion Disorder, Borderline Personality Disorder, etc.) * Patients addicted to alcohol, narcotics and other illegal substances * Patients with a known history of sensitivity to local anesthetics of the amide type, or to any other component of the product. * Patients with severe hepatic disease (assessment by GI specialist) * Pregnant Patients * Patients less than 18 years old
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Disability Index Score (PDI) at Six Months Following Surgical Procedure | After surgery until postoperative day 7, 30, 90 and 180 | Pain Disability Index score (PDI) ranges from 0 to 70, with higher scores reflecting higher interference of pain with daily activities. |
Countries
United States
Participant flow
Recruitment details
80 Enrolled
Participants by arm
| Arm | Count |
|---|---|
| LIDOCAINE PATCH 5% Lidoderm 5 % Topical 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 | 39 |
| Placebo Patch Placebo 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 | 39 |
| Total | 78 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 1 | 1 |
Baseline characteristics
| Characteristic | LIDOCAINE PATCH 5% | Placebo Patch | Total |
|---|---|---|---|
| Age, Continuous | 56 years STANDARD_DEVIATION 11 | 58 years STANDARD_DEVIATION 10 | 57 years STANDARD_DEVIATION 10 |
| Body mass index | 26 kg/m2 STANDARD_DEVIATION 4 | 25 kg/m2 STANDARD_DEVIATION 4 | 26 kg/m2 STANDARD_DEVIATION 4 |
| Diastolic blood pressure | 72 mmHg STANDARD_DEVIATION 12 | 70 mmHg STANDARD_DEVIATION 10 | 71 mmHg STANDARD_DEVIATION 11 |
| Sex: Female, Male Female | 8 Participants | 10 Participants | 18 Participants |
| Sex: Female, Male Male | 31 Participants | 29 Participants | 60 Participants |
| Systolic blood pressure | 125 mmHg STANDARD_DEVIATION 16 | 126 mmHg STANDARD_DEVIATION 14 | 126 mmHg STANDARD_DEVIATION 15 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 39 |
| other Total, other adverse events | 3 / 39 | 2 / 39 |
| serious Total, serious adverse events | 0 / 39 | 0 / 39 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LIDOCAINE PATCH 5% | Pain Disability Index Score (PDI) at Six Months Following Surgical Procedure | PDI on postoperative day 7 | 26 units on a scale | Standard Deviation 17 |
| LIDOCAINE PATCH 5% | Pain Disability Index Score (PDI) at Six Months Following Surgical Procedure | PDI on postoperative day 30 | 12 units on a scale | Standard Deviation 14 |
| LIDOCAINE PATCH 5% | Pain Disability Index Score (PDI) at Six Months Following Surgical Procedure | PDI on postoperative day 90 | 3.2 units on a scale | Standard Deviation 7.8 |
| LIDOCAINE PATCH 5% | Pain Disability Index Score (PDI) at Six Months Following Surgical Procedure | PDI on postoperative day 180 | 1.7 units on a scale | Standard Deviation 6.4 |
| Placebo Patch | Pain Disability Index Score (PDI) at Six Months Following Surgical Procedure | PDI on postoperative day 180 | 4.8 units on a scale | Standard Deviation 15.5 |
| Placebo Patch | Pain Disability Index Score (PDI) at Six Months Following Surgical Procedure | PDI on postoperative day 7 | 30 units on a scale | Standard Deviation 19 |
| Placebo Patch | Pain Disability Index Score (PDI) at Six Months Following Surgical Procedure | PDI on postoperative day 90 | 5.0 units on a scale | Standard Deviation 13.3 |
| Placebo Patch | Pain Disability Index Score (PDI) at Six Months Following Surgical Procedure | PDI on postoperative day 30 | 13 units on a scale | Standard Deviation 16 |
p-value: 0.2895% CI: [-7.11, 2.06]Mixed Models Analysis