Perioperative Chest PainNCT03120351
Lidocaine 5% Patch (Lidoderm) for the Prevention of Acute and Chest Pain Following Robotic Valve Surgery
A study testing Lidoderm 5 % Topical Patch in people with Perioperative Chest Pain, run by The Cleveland Clinic at 1 site in United States.
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perioperative Chest Pain
- What is being tested?
- Lidoderm 5 % Topical Patch
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Apr 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- consenting patients ≥ 18 years of age
- scheduled for robotic heart surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lidocaine 5% Patch (Lidoderm) for the Perioperative Prevention of Acute and Chronic Chest Pain Following Robotic Valve Surgery
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.
Read more
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
- Conditions
- Perioperative Chest Pain
- Being tested
- Lidoderm 5 % Topical Patch, Placebo patch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidoderm 5 % Topical PatchDrug
Also called Lidoderm
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 patchDrug
- 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
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine patch 5% | Experimental | 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. Receives: Drug: Lidoderm 5 % Topical Patch |
| Placebo Patch | Placebo comparator | 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. Receives: Drug: Placebo patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After surgery until postoperative day 7, 30, 90 and 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study startSep 2009
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Perioperative Chest PainStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Endo USA Inc., a Keenova Therapeutics Company
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03120351
- Sponsor's protocol ID
- 09-379
- Status last verified
- Apr 2020
- First submitted
- 21 Mar 2017
- Last updated
- 17 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lidocaine 5% Patch (Lidoderm) for the Perioperative Prevention of Acute and Chronic Chest Pain Following Robotic Valve Surgery
- ClinicalTrials.gov ID
- NCT03120351
- Acronym / sponsor ID
- 09-379
- Conditions
- Perioperative Chest Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Endo USA Inc., a Keenova Therapeutics Company
- Study start
- Sep 2009 (actual)
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 19 Apr 2017 (actual)
- Results
- Posted 17 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine patch 5% | Experimental | Drug: Lidoderm 5 % Topical Patch1) 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. |
| Placebo Patch | Placebo comparator | Drug: Placebo patch2) 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- consenting patients ≥ 18 years of age
- scheduled for robotic heart surgery
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidoderm 5 % Topical PatchAlso: LidodermPatients 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 | Drug | Lidocaine patch 5% |
| Placebo patch2) 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 | Drug | Placebo Patch |
Primary outcome
Pain Disability Index Score (PDI) at Six Months Following Surgical Procedure
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidoderm 5 % Topical Patch in people with Perioperative Chest Pain, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Disability Index Score (PDI) at Six Months Following Surgical Procedure (time frame: After surgery until postoperative day 7, 30, 90 and 180). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2020.