Pre-emptive Topical Lidocaine 5% Plaster for Prevention of Post-craniotomy Pain
- Conditions
- Postoperative PainLidocaine
- Interventions
- Drug: Placebo patch
- Registration Number
- NCT04169854
- Lead Sponsor
- Beijing Tiantan Hospital
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 180
- Age of 18 or older
- American Society of Anesthesiologists status I or II
- Registered for elective craniotomy
- Informed consent for participation in the trial
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo patch 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. Lidocaine Patch Lidocaine 5% patch 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.
- Primary Outcome Measures
Name Time Method Pain intensity 24 hours after craniotomy 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'.
- Secondary Outcome Measures
Name Time Method Time interval to analgesics 0-72 hours after craniotomy Time interval from the end of craniotomy to the first press of the PCA device and to the first rescue analgesic administration
Pain intensity 1, 4, 6, 12, 48 and 72 hours after craniotomy 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'.
Cumulative butorphanol 24, 48 and 72 hours after craniotomy he cumulative butorphanol consumption through the PCA device
Cumulative intraoperative analgesics consumption During the craniotomy Cumulative intraoperative opioids consumption
Length of hospital stay within 3 months Time length from admission to leaving the hospital
Lidocaine 5% plaster safety (local) 3 preoperative days Rate of patients with local adverse event as graded using NCI-CTCAE V4.0
Lidocaine 5% plaster safety (systemic) 3 preoperative days Rate of patients with systemic adverse event as graded using NCI-CTCAE V4.0
Pittsburgh Sleep Quality Index (PSQI) first 3 days after craniotomy. 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).
Trial Locations
- Locations (1)
Beijing Tiantan Hospital
🇨🇳Beijing, Beijing, China