Pre-emptive Topical Lidocaine 5% Plaster for Prevention of Post-craniotomy Pain

Study Overview
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Brief Summary
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Postcraniotomy pain remains a common phenomenon in the neurosurgery field. Managements for postcraniotomy pain are to be standardised and optimized. In the proposed study, the investigators aim to provide a novel regional non-invasive prophylactic strategy for postcraniotomy pain by utilizing Lidocaine 5% plaster.

Detailed Description
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Postcraniotomy pain remains a common phenomenon in the neurosurgery field. Insufficient control of postcraniotomy pain may lead to unexpected clinical outcomes. The current management for postcraniotomy pain mainly involves systemic intravenous or oral medication and regional anaesthetic injection. The investigators intend to compare pre-emptive lidocaine 5% plaster incision covering to a placebo for prophylaxis of postcraniotomy pain. In the proposed study, the effectiveness and safety of lidocaine 5% plaster for postcraniotomy pain control will be examined compared with those of placebo. The investigators aim to provide a novel regional non-invasive prophylactic strategy for postcraniotomy pain.

Official Title
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Pre-emptive Topical Lidocaine 5% Plaster for Prevention of Post-craniotomy Pain : a Protocol for a Randomized, Triple Blind, Placebo-controlled Trail

Conditions
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Postoperative Pain, Lidocaine

Intervention / Treatment
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* Drug: Lidocaine 5% patch
* Drug: Placebo patch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of 18 or older American Society of Anesthesiologists status I or II Registered for elective craniotomy Informed consent for participation in the trial Exclusion Criteria: Allergy to lidocaine or the hydrogel plaster Chronic headache, craniofacial pain or neuralgia Glasgow Coma Scale less than 15 Current or previous cardiovascular or cerebrovascular accident Expected delayed recovery or extubation Uncontrolled arrhythmia History of intracranial operation Emergency or revision craniotomy Mental illness, psychiatric drug use or alcohol abuse Failure to understand the use of a 100 mm VAS or the PCA

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidocaine Patch<br>Surgeons will be asked to mark the planned incisions site 3 days before craniotomy. The masked Lidocaine 5% patch will be applied to cover the insicion mark as well as the head-holders sites within 6:00 P.M. to 6:00 A.M. for 3 consecutive preoperative days. | Drug: Lidocaine 5% patch<br>* The Lidocaine 5% Patch will be applied to cover the marked incision site and head-holders sites for 3 consecutive preoperative days between 6:00 P.M. to 6:00 A.M.. Research assistants will be responsible for instructing patients to cover the patches correctly.<br>|
| Placebo Comparator: Placebo<br>Surgeons will be asked to mark the planned incisions site 3 days before craniotomy. The masked placebo patch will be applied to cover the insicion mark as well as the head-holders sites within 6:00 P.M. to 6:00 A.M. for 3 consecutive preoperative days. | Drug: Placebo patch<br>* The Placebo Patch will be applied to cover the marked incision site and head-holders sites for 3 consecutive preoperative days between 6:00 P.M. to 6:00 A.M.. Research assistants will be responsible for instructing patients to cover the patches correctly.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | Pain intensity will be examined using the 0 - 100 mm visual analogue scale scores, where '0' represents 'no pain' ,and '100' represents 'the most severe pain'. | 24 hours after craniotomy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | Pain intensity will be examined using the 0 - 100 mm visual analogue scale scores, where '0' represents 'no pain' ,and '100' represents 'the most severe pain'. | 1, 4, 6, 12, 48 and 72 hours after craniotomy | 
| Time interval to analgesics | Time interval from the end of craniotomy to the first press of the PCA device and to the first rescue analgesic administration | 0-72 hours after craniotomy | 
| Cumulative butorphanol | he cumulative butorphanol consumption through the PCA device | 24, 48 and 72 hours after craniotomy | 
| Cumulative intraoperative analgesics consumption | Cumulative intraoperative opioids consumption | During the craniotomy | 
| Length of hospital stay | Time length from admission to leaving the hospital | within 3 months | 
| Lidocaine 5% plaster safety (local) | Rate of patients with local adverse event as graded using NCI-CTCAE V4.0 | 3 preoperative days | 
| Lidocaine 5% plaster safety (systemic) | Rate of patients with systemic adverse event as graded using NCI-CTCAE V4.0 | 3 preoperative days | 
| Pittsburgh Sleep Quality Index (PSQI) | The Pittsburgh Sleep Quality Index (PSQI) contains 19 self-rated questions which measures seven aspects of sleep: (1) subjective sleep quality, (2) sleep latency, (3) sleep duration, (4) habitual sleep efficiency, (5) sleep disturbances, (6) use of sleeping medication, and (7) daytime dysfunction. The 19 self-rated items are combined to form seven component scores, each of which has a range of 0-3 points (0 indicates no difficulty, while 3 indicates severe difficulty). The seven component scores are then summed to yield one global score, with a range of 0-21 points (0 indicating no difficulty, and 21 indicating severe difficulties in all the seven areas of sleep quality). | first 3 days after craniotomy. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lidocaine Patch, Postoperative Pain, Postcraniotomy Pain