Trial Outcomes & Findings for Lidocaine 5% Patch (Lidoderm) for the Prevention of Acute and Chest Pain Following Robotic Valve Surgery (NCT NCT03120351)

Results Overview

Pain Disability Index score (PDI) ranges from 0 to 70, with higher scores reflecting higher interference of pain with daily activities.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

80 participants

Primary outcome timeframe

After surgery until postoperative day 7, 30, 90 and 180

Results posted on

2020-04-17

80 Enrolled

Participant milestones
Measure	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	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
Overall Study STARTED	40	40
Overall Study COMPLETED	39	39
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal
Measure	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	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
Overall Study Physician Decision	1	1

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

Baseline characteristics by cohort
Measure	LIDOCAINE PATCH 5% n=39 Participants 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 n=39 Participants 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 n=78 Participants Total of all reporting groups
Age, Continuous	56 years STANDARD_DEVIATION 11 • n=5 Participants	58 years STANDARD_DEVIATION 10 • n=7 Participants	57 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants	29 Participants n=7 Participants	60 Participants n=5 Participants
Body mass index	26 kg/m2 STANDARD_DEVIATION 4 • n=5 Participants	25 kg/m2 STANDARD_DEVIATION 4 • n=7 Participants	26 kg/m2 STANDARD_DEVIATION 4 • n=5 Participants
Systolic blood pressure	125 mmHg STANDARD_DEVIATION 16 • n=5 Participants	126 mmHg STANDARD_DEVIATION 14 • n=7 Participants	126 mmHg STANDARD_DEVIATION 15 • n=5 Participants
Diastolic blood pressure	72 mmHg STANDARD_DEVIATION 12 • n=5 Participants	70 mmHg STANDARD_DEVIATION 10 • n=7 Participants	71 mmHg STANDARD_DEVIATION 11 • n=5 Participants

Timeframe: 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.

Outcome measures
Measure	LIDOCAINE PATCH 5% n=39 Participants 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 n=39 Participants 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
Pain Disability Index Score (PDI) at Six Months Following Surgical Procedure PDI on postoperative day 7	26 units on a scale Standard Deviation 17	30 units on a scale Standard Deviation 19
Pain Disability Index Score (PDI) at Six Months Following Surgical Procedure PDI on postoperative day 30	12 units on a scale Standard Deviation 14	13 units on a scale Standard Deviation 16
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	5.0 units on a scale Standard Deviation 13.3
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	4.8 units on a scale Standard Deviation 15.5

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events
Measure	LIDOCAINE PATCH 5% n=39 participants at risk 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 n=39 participants at risk 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
Nervous system disorders confusion	0.00% 0/39 • 6 months	0.00% 0/39 • 6 months

Other adverse events
Measure	LIDOCAINE PATCH 5% n=39 participants at risk 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 n=39 participants at risk 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
Nervous system disorders Confusion	2.6% 1/39 • 6 months	0.00% 0/39 • 6 months
Cardiac disorders atrial arrhythmia	2.6% 1/39 • 6 months	0.00% 0/39 • 6 months
Nervous system disorders neurological deficit	2.6% 1/39 • 6 months	0.00% 0/39 • 6 months
General disorders Ches wall hernia	0.00% 0/39 • 6 months	2.6% 1/39 • 6 months
General disorders Pleural effusion	0.00% 0/39 • 6 months	2.6% 1/39 • 6 months

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