Postoperative Pain, Lidocaine
Conditions
Keywords
Postoperative Pain, Postcraniotomy Pain, Lidocaine Patch
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.
Interventions
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.
DRUGPlacebo patch
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.
Sponsors
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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'. |
| 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). |
| Length of hospital stay | within 3 months | Time length from admission to leaving the hospital |
Countries
China
Contacts
Primary ContactFang Luo, MD
Outcome results
None listed