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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
180
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.
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.
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China
RECRUITINGPain 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'.
Time frame: 24 hours after craniotomy
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'.
Time frame: 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
Time frame: 0-72 hours after craniotomy
Cumulative butorphanol
he cumulative butorphanol consumption through the PCA device
Time frame: 24, 48 and 72 hours after craniotomy
Cumulative intraoperative analgesics consumption
Cumulative intraoperative opioids consumption
Time frame: During the craniotomy
Length of hospital stay
Time length from admission to leaving the hospital
Time frame: within 3 months
Lidocaine 5% plaster safety (local)
Rate of patients with local adverse event as graded using NCI-CTCAE V4.0
Time frame: 3 preoperative days
Lidocaine 5% plaster safety (systemic)
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Rate of patients with systemic adverse event as graded using NCI-CTCAE V4.0
Time frame: 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).
Time frame: first 3 days after craniotomy.