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

• Sponsor: The Cleveland Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT03120351
• Collaborator: Endo Pharmaceuticals (Industry)
• Enrollment: 80
• Location: 1
• Arms: 2
• Actual Duration (Months): 19
• Patients Per Site Per Month: 4.2

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Perioperative Chest Pain	Drug: Lidoderm 5 % Topical Patch; Drug: Placebo patch	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Masking Description: Double-blind
• Primary Purpose: Treatment
• Official Title: Lidocaine 5% Patch (Lidoderm) for the Perioperative Prevention of Acute and Chronic Chest Pain Following Robotic Valve Surgery
• Actual Study Start Date: Sep 1, 2009
• Actual Primary Completion Date: Apr 1, 2011
• Actual Study Completion Date: Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lidocaine patch 5% 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; 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; Other Names: Lidoderm
Placebo Comparator: 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. 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; 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

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cleveland Clinic	Cleveland	Ohio	United States	44195

Sponsors and Collaborators

• The Cleveland Clinic
• Endo Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT03120351
• Other Study ID Numbers: 09-379
• First Posted: Apr 19, 2017
• Last Update Posted: Apr 17, 2020
• Last Verified: Apr 1, 2020

• Additional relevant MeSH terms: Chest Pain; Lidocaine

Study Results

Participant Flow

Recruitment Details	80 Enrolled

Arm/Group Title	LIDOCAINE PATCH 5%	Placebo Patch
Arm/Group Description	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	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
Period Title: Overall Study
STARTED	40	40
COMPLETED	39	39
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	LIDOCAINE PATCH 5%	Placebo Patch	Total
Arm/Group Description	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	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	Total of all reporting groups
Overall Participants	39	39	78
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	56 (11)	58 (10)	57 (10)
Sex: Female, Male (Count of Participants)
Female	8 20.5%	10 25.6%	18 23.1%
Male	31 79.5%	29 74.4%	60 76.9%
Body mass index (kg/m2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m2]	26 (4)	25 (4)	26 (4)
Systolic blood pressure (mmHg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmHg]	125 (16)	126 (14)	126 (15)
Diastolic blood pressure (mmHg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmHg]	72 (12)	70 (10)	71 (11)

Outcome Measures

1. Primary Outcome

Title	Pain Disability Index Score (PDI) at Six Months Following Surgical Procedure
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	LIDOCAINE PATCH 5%	Placebo Patch
Arm/Group Description	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	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
Measure Participants	39	39
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)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	LIDOCAINE PATCH 5%, Placebo Patch
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.28
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-2.5
	Confidence Interval	(2-Sided) 95%; -7.11 to 2.06
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	6 months
Arm/Group Title	LIDOCAINE PATCH 5%		Placebo Patch
Arm/Group Description	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		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
All Cause Mortality
	LIDOCAINE PATCH 5%		Placebo Patch
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/39 (0%)		0/39 (0%)
Serious Adverse Events
	LIDOCAINE PATCH 5%		Placebo Patch
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/39 (0%)		0/39 (0%)
Nervous system disorders
confusion	/39 (NaN)		/39 (NaN)
Other (Not Including Serious) Adverse Events
	LIDOCAINE PATCH 5%		Placebo Patch
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/39 (7.7%)		2/39 (5.1%)
Cardiac disorders
atrial arrhythmia	1/39 (2.6%)		0/39 (0%)
General disorders
Ches wall hernia	0/39 (0%)		1/39 (2.6%)
Pleural effusion	0/39 (0%)		1/39 (2.6%)
Nervous system disorders
Confusion	1/39 (2.6%)		0/39 (0%)
neurological deficit	1/39 (2.6%)		0/39 (0%)

Limitations/Caveats

Original PI (L. Kapural) and second PI (B. Vrooman) are no longer working at ClevelandCF

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.