Ignite Creation Date:
2024-05-06 @ 9:59 AM
Last Modification Date:
2024-10-26 @ 12:22 PM
Study NCT ID:
NCT03120351
Status:
COMPLETED
Last Update Posted:
2020-04-17
First Post:
2017-03-21
Brief Title:
Lidocaine 5 Patch Lidoderm for the Prevention of Acute and Chest Pain Following Robotic Valve Surgery
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
Official Title:
Lidocaine 5 Patch Lidoderm for the Perioperative Prevention of Acute and Chronic Chest Pain Following Robotic Valve Surgery
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None