Pain, PostoperativeNCT02751619
Preventive Skin Analgesia With Lidocaine Patch 5% for Controlling Post-thoracotomy Pain
A study testing Lidocaine patch 5% in people with Pain, Postoperative, run by University of Campania Luigi Vanvitelli.
Trial summary
Thoracotomy is one of the most painful surgical incision. Uncontrolled acute post-thoracotomy pain reducing deep breathing exercises and secretion clearance increased the incidence of postoperative pulmonary complications including atelectasis, hypoxemia, and postoperative pulmonary infections. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Lidocaine patch 5%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- More than 18 years old
- Anatomical resection by standard lateral thoracotomy for treatment of non small cell lung cancer
Who cannot join
- Allergy to Lidocaine
- American Society of Anaesthesiologist (ASA) classification score more than 3
- History of previous thoracic surgical procedures and/or of chronic pain or taking regular analgesics
- Pneumonectomy or concomitant decortication and/or chest wall injury or resection,
- Psychiatric illness
- Participation to other studies
About this study
Official title: Preventive Application Of Lidocaine Patch In Adjunction To Intravenous Morphine Analgesia For Management Of Post-Thoracotomy Pain: Results Of A Randomized, Double Blind, Placebo Controlled Study
Thoracotomy is one of the most painful surgical incision. Uncontrolled acute post-thoracotomy pain reducing deep breathing exercises and secretion clearance increased the incidence of postoperative pulmonary complications including atelectasis, hypoxemia, and postoperative pulmonary infections. Thus, an effective analgesia is crucial in order to reduce perioperative morbidity and hospitalization time and also to prevent chronic post-thoracotomy pain.
Thoracic epidural analgesia and thoracic paravertebral analgesia are currently the standard strategies for thoracic surgery but the difficult of performing them in all patients and their potential complications are all factors that limit their use. Systemic administration of opioids is the simplest and common strategy to provide analgesia but it may be associated with several undesirable effects, such as respiratory depression, sedation, nausea, constipation and vomiting.
Read more
In the recent years, preventive analgesia is become one of the most promising strategy of postoperative pain control. It is based on the concept of administering analgesic drugs before the occurrence of nociceptive input in order to prevent central sensitization. The efficacy of preemptive analgesia is unclear and there is no a consensus on its efficacy on controlling pain after thoracic procedure.
Pain following thoracotomy has a multifactorial genesis including surgical incision, intercostal nerve injury, pleural inflammation, and damage of pulmonary parenchyma and of diaphragm. Thus, a multimodal analgesia that intercepts the signalizing at numerous locations could be more effective than a single strategy targeting one site along the pain pathway.
Thus, in the present study, the clinical hypothesis was that the preemptive analgesia of the skin using a new tool as the Lidocaine patch 5% would improve the analgesic effects of systemic morphine analgesia for controlling post-operative pain following thoracotomy.
Read the detailed description
This was an unicenter, double-blinded, placebo controlled, parallel-group, prospective study conducted at Thoracic Surgery Unit and Anesthesia and Intensive Care Unit of Second University of Naples from January 2013 to May 2015.
All consecutive patients undergoing undergoing anatomical resection by standard lateral thoracotomy for treatment of non small cell lung cancer (NSCLC) were randomly assigned to Lidocaine or Placebo group in 1:1 ratio and no changes to methods after trial commencement as type of randomization or eligibility criteria were attended.
For patients assigned to active group, Lidocaine patch 5% (Lidoderm®, Endo Pharmaceuticals Inc, Malvern, PA, USA) measuring 10 x 14 cm and containing 700 mg of Lidocaine, was applied to cover the planned skin incision, marked with a pen by surgeon. Patch was applied for 12 hours during the night, removed for the subsequent 12 hours during the day, and then a new patch was applied at the same level the night after. This process was continued for 3 days before thoracotomy. In the control group, a placebo patch, that was identical in appearance to the active patch but did not contain Lidocaine, was applied in the same manner for the same time. The pain service, surgical team, and patients were all blinded to treatment group assigned.
All patients received the same anesthetic protocol. All operations were performed in the early morning just after that the patch was removed. The general anesthesia was inducted with i.v. midazolam 0.05 mg/kg, i.v. fentanyl 1-1.4 µg/Kg, i.v. propofol 2.5 mg/kg, i.v. and rocuronium bromide 0.6 mg/kg. The patient was maintained with desflurane 4-6%, sulfentanil 0.5-1 micro/Kg, rocuronium bromide 0.6-0.8 mg/Kg, based on heart rate and blood pressure stability. A selective ventilation was performed with a double-lumen endobronchial tube in all cases and no additional analgesics were injected during surgery.
All patients had the same length of skin incision and a standard muscle-sparing lateral thoracotomy. The latissimus dorsi muscle and the underlying serratus anterior muscle were spared and the chest was entered over the top of the unresected and unshingled sixth rib. A standard Finocchietto chest retractor was then placed and slowly opened to avoid rib fracture. After completion of the appropriate anatomical lung resection, a single 28 F chest drainage was systematically placed in pleural cavity. The same chest closure was performed in all patients in a standard manner using intracostal sutures.
Patient was extubated in the operating room and transferred to the surgical ward. The postoperative analgesia was performed with intravenous morphine administered through Patient Controlled-Analgesia (Automed 3300, AceMedical Co.) delivery. Morphine 1 mg was given for each request and continuous infusion was at a rate of 1 mg/h. Both groups had a 10 min lockout period and a safe higher limit of 20 mg in 4 hours. If VAS scores exceeded 4/10 scores, rescue analgesia was intravenously administered according to a standardized institutional protocol for pain treatment until the pain was relieved to a level falling below a VAS score < 4. Patient Controlled Analgesia (PCA) was continued for up to 2 days, until patients could tolerate oral opioid medications and/or anti-inflammatory analgesics. However, these medications were not considered in the analysis.
The intergroup differences were assessed in order to evaluate whether the pre-emptive analgesia obtained with Lidocaine patch would have effects on pain scores (primary end-point), consumption of analgesics, recovery of respiratory function and peripheral painful pathways (secondary end-points).
- Conditions
- Pain, Postoperative
- Being tested
- Lidocaine patch 5%, Placebo patch
- Keywords
- Pre-emptive analgesia, Post-thoracotomy pain, Lidocaine patch
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine patch 5%Drug
Also called Lidoderm® (Endo Pharmaceuticals Inc, Malvern, PA, USA)
Lidocaine patch 5% was applied to cover the planned skin incision for 12 hours during the night and then was removed for the subsequent 12 hours during the day. This process was continued for 3 days before thoracotomy
Placebo patchDrug
A patch without lidocaine was applied to cover the planned skin incision for 12 hours during the night and then was removed for the subsequent 12 hours during the day. This process was continued for 3 days before thoracotomy
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine Group | Experimental | Lidocaine patch 5% (Lidoderm®, Endo Pharmaceuticals Inc, Malvern, PA, USA) measuring 10 x 14 cm and containing 700 mg of Lidocaine, was applied to cover the planned skin incision, marked with a pen by surgeon. Patch was applied for 12 hours during the night, removed for the subsequent 12 hours during the day, and then a new patch was applied at the same level the night after. This process was continued for 3 days before thoracotomy Receives: Drug: Lidocaine patch 5% |
| Placebo Patch | Active comparator | A patch, that was identical in appearance to the active patch but did not contain Lidocaine, was applied to cover the planned skin incision, marked with a pen by surgeon. Patch was applied for 12 hours during the night, removed for the subsequent 12 hours during the day, and then a new patch was applied at the same level the night after. This process was continued for 3 days before thoracotomy Receives: Drug: Placebo patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Pain Score measured with Visual Analogue Scale at rest and after coughing
10-score Visual Analogue Scale (VAS) ranging from 0=absence of pain to 10= maximal level of pain
Measured: Post-operative follow-up-points: 6 hours, 12 hours , 24 hours , 36 hours, 48 hours and 72 hours
Secondary outcomes (5)
The frequency for hour of activation of PCA Device
The sum of the frequency of activation of PCA system
Measured: Post-operative follow-up: 6 hours; 6-12 hours; 12- 24 hours; 24-36 hours, and 36-48 hours.
Morphine consumption
The total morphine consumption expressed (the sum of additional intravenous morphine bolus infusions and the morphine delivered by the PCA system)
Measured: Post-operative follow-up: 6 hours; 6-12 hours; 12- 24 hours; 24-36 hours, and 36-48 hours.
Flow Expiratory Volume in one second (FEV1%)
The best of three efforts measured with a spirometer was used for the analysis.
Measured: Post-operative follow-up: 72 hours; 96 hours; 120 hours
Forced Vital Capacity (FVC%)
The best of three efforts measured with a spirometer was used for the analysis.
Measured: Post-operative follow-up: 72 hours; 96 hours; 120 hours
Laser Evoked Potential Tests.
Laser stimulation, delivered by Nd:YAG (neodymium-doped yttrium aluminium garnet (Nd:YAG) laser, was applied at level of thoracotomy scar, the main territory corresponding to the distribution of pain. The results were evaluated for amplitude and latency differences between the vertex negativity (N2) appearing around 240 ms and the following positivity (P2) appearing around 360 ms after stimulus onset.
Measured: Follow-up: 1 month, 3 months, and 6 months after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2016 (estimated)
- Study startJan 2013
- Primary completionMay 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- 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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alfonso Fiorelli, University of Campania Luigi Vanvitelli
- Investigators
- Mario Santini, MD, Study chair, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02751619
- Sponsor's protocol ID
- 436/2012
- Status last verified
- Apr 2016
- First submitted
- 17 Apr 2016
- Last updated
- 26 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Cerfolio RJ, Bryant AS, Bass CS, Bartolucci AA. A prospective, double-blinded, randomized trial evaluating the use of preemptive analgesia of the skin before thoracotomy. Ann Thorac Surg. 2003 Oct;76(4):1055-8. doi: 10.1016/s0003-4975(03)01023-3.
PubMed 14529984Garzon-Rodriguez C, Casals Merchan M, Calsina-Berna A, Lopez-Romboli E, Porta-Sales J. Lidocaine 5 % patches as an effective short-term co-analgesic in cancer pain. Preliminary results. Support Care Cancer. 2013 Nov;21(11):3153-8. doi: 10.1007/s00520-013-1948-7. Epub 2013 Sep 3.
PubMed 24000041Vrooman B, Kapural L, Sarwar S, Mascha EJ, Mihaljevic T, Gillinov M, Qavi S, Sessler DI. Lidocaine 5% Patch for Treatment of Acute Pain After Robotic Cardiac Surgery and Prevention of Persistent Incisional Pain: A Randomized, Placebo-Controlled, Double-Blind Trial. Pain Med. 2015 Aug;16(8):1610-21. doi: 10.1111/pme.12721. Epub 2015 Jul 14.
PubMed 26176878Habib AS, Polascik TJ, Weizer AZ, White WD, Moul JW, ElGasim MA, Gan TJ. Lidocaine patch for postoperative analgesia after radical retropubic prostatectomy. Anesth Analg. 2009 Jun;108(6):1950-3. doi: 10.1213/ane.0b013e3181a21185.
PubMed 19448228Cheng YJ. Lidocaine Skin Patch (Lidopat(R) 5%) Is Effective in the Treatment of Traumatic Rib Fractures: A Prospective Double-Blinded and Vehicle-Controlled Study. Med Princ Pract. 2016;25(1):36-9. doi: 10.1159/000441002. Epub 2015 Nov 6.
PubMed 26539836
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventive Application Of Lidocaine Patch In Adjunction To Intravenous Morphine Analgesia For Management Of Post-Thoracotomy Pain: Results Of A Randomized, Double Blind, Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT02751619
- Acronym / sponsor ID
- 436/2012
- Conditions
- Pain, Postoperative
- Keywords
- Pre-emptive analgesia, Post-thoracotomy pain, Lidocaine patch
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- May 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 26 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Thoracotomy is one of the most painful surgical incision. Uncontrolled acute post-thoracotomy pain reducing deep breathing exercises and secretion clearance increased the incidence of postoperative pulmonary complications including atelectasis, hypoxemia, and postoperative pulmonary infections. Thus, an effective analgesia is crucial in order to reduce perioperative morbidity and hospitalization time and also to prevent chronic post-thoracotomy pain.
Thoracic epidural analgesia and thoracic paravertebral analgesia are currently the standard strategies for thoracic surgery but the difficult of performing them in all patients and their potential complications are all factors that limit their use. Systemic administration of opioids is the simplest and common strategy to provide analgesia but it may be associated with several undesirable effects, such as respiratory depression, sedation, nausea, constipation and vomiting.
In the recent years, preventive analgesia is become one of the most promising strategy of postoperative pain control. It is based on the concept of administering analgesic drugs before the occurrence of nociceptive input in order to prevent central sensitization. The efficacy of preemptive analgesia is unclear and there is no a consensus on its efficacy on controlling pain after thoracic procedure.
Pain following thoracotomy has a multifactorial genesis including surgical incision, intercostal nerve injury, pleural inflammation, and damage of pulmonary parenchyma and of diaphragm. Thus, a multimodal analgesia that intercepts the signalizing at numerous locations could be more effective than a single strategy targeting one site along the pain pathway.
Thus, in the present study, the clinical hypothesis was that the preemptive analgesia of the skin using a new tool as the Lidocaine patch 5% would improve the analgesic effects of systemic morphine analgesia for controlling post-operative pain following thoracotomy.
Detailed description
This was an unicenter, double-blinded, placebo controlled, parallel-group, prospective study conducted at Thoracic Surgery Unit and Anesthesia and Intensive Care Unit of Second University of Naples from January 2013 to May 2015.
All consecutive patients undergoing undergoing anatomical resection by standard lateral thoracotomy for treatment of non small cell lung cancer (NSCLC) were randomly assigned to Lidocaine or Placebo group in 1:1 ratio and no changes to methods after trial commencement as type of randomization or eligibility criteria were attended.
For patients assigned to active group, Lidocaine patch 5% (Lidoderm®, Endo Pharmaceuticals Inc, Malvern, PA, USA) measuring 10 x 14 cm and containing 700 mg of Lidocaine, was applied to cover the planned skin incision, marked with a pen by surgeon. Patch was applied for 12 hours during the night, removed for the subsequent 12 hours during the day, and then a new patch was applied at the same level the night after. This process was continued for 3 days before thoracotomy. In the control group, a placebo patch, that was identical in appearance to the active patch but did not contain Lidocaine, was applied in the same manner for the same time. The pain service, surgical team, and patients were all blinded to treatment group assigned.
All patients received the same anesthetic protocol. All operations were performed in the early morning just after that the patch was removed. The general anesthesia was inducted with i.v. midazolam 0.05 mg/kg, i.v. fentanyl 1-1.4 µg/Kg, i.v. propofol 2.5 mg/kg, i.v. and rocuronium bromide 0.6 mg/kg. The patient was maintained with desflurane 4-6%, sulfentanil 0.5-1 micro/Kg, rocuronium bromide 0.6-0.8 mg/Kg, based on heart rate and blood pressure stability. A selective ventilation was performed with a double-lumen endobronchial tube in all cases and no additional analgesics were injected during surgery.
All patients had the same length of skin incision and a standard muscle-sparing lateral thoracotomy. The latissimus dorsi muscle and the underlying serratus anterior muscle were spared and the chest was entered over the top of the unresected and unshingled sixth rib. A standard Finocchietto chest retractor was then placed and slowly opened to avoid rib fracture. After completion of the appropriate anatomical lung resection, a single 28 F chest drainage was systematically placed in pleural cavity. The same chest closure was performed in all patients in a standard manner using intracostal sutures.
Patient was extubated in the operating room and transferred to the surgical ward. The postoperative analgesia was performed with intravenous morphine administered through Patient Controlled-Analgesia (Automed 3300, AceMedical Co.) delivery. Morphine 1 mg was given for each request and continuous infusion was at a rate of 1 mg/h. Both groups had a 10 min lockout period and a safe higher limit of 20 mg in 4 hours. If VAS scores exceeded 4/10 scores, rescue analgesia was intravenously administered according to a standardized institutional protocol for pain treatment until the pain was relieved to a level falling below a VAS score < 4. Patient Controlled Analgesia (PCA) was continued for up to 2 days, until patients could tolerate oral opioid medications and/or anti-inflammatory analgesics. However, these medications were not considered in the analysis.
The intergroup differences were assessed in order to evaluate whether the pre-emptive analgesia obtained with Lidocaine patch would have effects on pain scores (primary end-point), consumption of analgesics, recovery of respiratory function and peripheral painful pathways (secondary end-points).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine Group | Experimental | Drug: Lidocaine patch 5%Lidocaine patch 5% (Lidoderm®, Endo Pharmaceuticals Inc, Malvern, PA, USA) measuring 10 x 14 cm and containing 700 mg of Lidocaine, was applied to cover the planned skin incision, marked with a pen by surgeon. Patch was applied for 12 hours during the night, removed for the subsequent 12 hours during the day, and then a new patch was applied at the same level the night after. This process was continued for 3 days before thoracotomy |
| Placebo Patch | Active comparator | Drug: Placebo patchA patch, that was identical in appearance to the active patch but did not contain Lidocaine, was applied to cover the planned skin incision, marked with a pen by surgeon. Patch was applied for 12 hours during the night, removed for the subsequent 12 hours during the day, and then a new patch was applied at the same level the night after. This process was continued for 3 days before thoracotomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- More than 18 years old
- Anatomical resection by standard lateral thoracotomy for treatment of non small cell lung cancer
Key exclusion criteria (6 listed)
- Allergy to Lidocaine
- American Society of Anaesthesiologist (ASA) classification score more than 3
- History of previous thoracic surgical procedures and/or of chronic pain or taking regular analgesics
- Pneumonectomy or concomitant decortication and/or chest wall injury or resection,
- Psychiatric illness
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 |
|---|---|---|
| Lidocaine patch 5%Also: Lidoderm® (Endo Pharmaceuticals Inc, Malvern, PA, USA)Lidocaine patch 5% was applied to cover the planned skin incision for 12 hours during the night and then was removed for the subsequent 12 hours during the day. This process was continued for 3 days before thoracotomy | Drug | Lidocaine Group |
| Placebo patchA patch without lidocaine was applied to cover the planned skin incision for 12 hours during the night and then was removed for the subsequent 12 hours during the day. This process was continued for 3 days before thoracotomy | Drug | Placebo Patch |
Primary outcome
Changes in Pain Score measured with Visual Analogue Scale at rest and after coughing
Time frame: Post-operative follow-up-points: 6 hours, 12 hours , 24 hours , 36 hours, 48 hours and 72 hours
10-score Visual Analogue Scale (VAS) ranging from 0=absence of pain to 10= maximal level of pain
5 secondary outcomes
The frequency for hour of activation of PCA Device
Time frame: Post-operative follow-up: 6 hours; 6-12 hours; 12- 24 hours; 24-36 hours, and 36-48 hours.
Morphine consumption
Time frame: Post-operative follow-up: 6 hours; 6-12 hours; 12- 24 hours; 24-36 hours, and 36-48 hours.
Flow Expiratory Volume in one second (FEV1%)
Time frame: Post-operative follow-up: 72 hours; 96 hours; 120 hours
Forced Vital Capacity (FVC%)
Time frame: Post-operative follow-up: 72 hours; 96 hours; 120 hours
Laser Evoked Potential Tests.
Time frame: Follow-up: 1 month, 3 months, and 6 months after operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2016.
- Background: PubMed 14529984Cerfolio RJ, Bryant AS, Bass CS, Bartolucci AA. A prospective, double-blinded, randomized trial evaluating the use of preemptive analgesia of the skin before thoracotomy. Ann Thorac Surg. 2003 Oct;76(4):1055-8. doi: 10.1016/s0003-4975(03)01023-3.
- Background: PubMed 24000041Garzon-Rodriguez C, Casals Merchan M, Calsina-Berna A, Lopez-Romboli E, Porta-Sales J. Lidocaine 5 % patches as an effective short-term co-analgesic in cancer pain. Preliminary results. Support Care Cancer. 2013 Nov;21(11):3153-8. doi: 10.1007/s00520-013-1948-7. Epub 2013 Sep 3.
- Background: PubMed 26176878Vrooman B, Kapural L, Sarwar S, Mascha EJ, Mihaljevic T, Gillinov M, Qavi S, Sessler DI. Lidocaine 5% Patch for Treatment of Acute Pain After Robotic Cardiac Surgery and Prevention of Persistent Incisional Pain: A Randomized, Placebo-Controlled, Double-Blind Trial. Pain Med. 2015 Aug;16(8):1610-21. doi: 10.1111/pme.12721. Epub 2015 Jul 14.
- Background: PubMed 19448228Habib AS, Polascik TJ, Weizer AZ, White WD, Moul JW, ElGasim MA, Gan TJ. Lidocaine patch for postoperative analgesia after radical retropubic prostatectomy. Anesth Analg. 2009 Jun;108(6):1950-3. doi: 10.1213/ane.0b013e3181a21185.
- Background: PubMed 26539836Cheng YJ. Lidocaine Skin Patch (Lidopat(R) 5%) Is Effective in the Treatment of Traumatic Rib Fractures: A Prospective Double-Blinded and Vehicle-Controlled Study. Med Princ Pract. 2016;25(1):36-9. doi: 10.1159/000441002. Epub 2015 Nov 6.
- Individual participant dataSharing planned: Yes
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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.
Mario Santini, MD study chair
University of Campania Luigi Vanvitelli
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine patch 5% in people with Pain, Postoperative, run by University of Campania Luigi Vanvitelli.
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 6 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 26 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in Pain Score measured with Visual Analogue Scale at rest and after coughing (time frame: Post-operative follow-up-points: 6 hours, 12 hours , 24 hours , 36 hours, 48 hours and 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02751619, which also lists 5 linked publications.
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 26 Apr 2016.