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

Capital Medical University

Status and phase: Unknown; Phase 3

Conditions: Postoperative Pain; Lidocaine

Treatments: Drug: Lidocaine 5% patch; Drug: Placebo patch

Study type: Interventional

Funder types: Other

Identifiers

NCT04169854

KY 2019-122-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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180 participants in 2 patient groups, including a placebo group

Lidocaine Patch

Experimental group

Description:

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.

Treatment:

Drug: Lidocaine 5% patch

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo patch