Clinical trial NCT04169854: Pre-emptive Topical Lidocaine 5% Plaster for Prevention of Post-craniotomy Pain
Official title: Pre-emptive Topical Lidocaine 5% Plaster for Prevention of Post-craniotomy Pain : a Protocol for a Randomized, Triple Blind, Placebo-controlled Trail
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Postoperative Pain
Lidocaine
Keywords: Postoperative Pain
Postcraniotomy Pain
Lidocaine Patch
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2019-11-20
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain intensity
timeFrame: 24 hours after craniotomy
Secondary outcomes:
measure: Pain intensity
timeFrame: 1, 4, 6, 12, 48 and 72 hours after craniotomy
measure: Time interval to analgesics
timeFrame: 0-72 hours after craniotomy
measure: Cumulative butorphanol
timeFrame: 24, 48 and 72 hours after craniotomy
measure: Cumulative intraoperative analgesics consumption
timeFrame: During the craniotomy
measure: Length of hospital stay
timeFrame: within 3 months
measure: Lidocaine 5% plaster safety (local)
timeFrame: 3 preoperative days
measure: Lidocaine 5% plaster safety (systemic)
timeFrame: 3 preoperative days
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: first 3 days after craniotomy.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital
name: Fang Luo, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Mordhorst C, Latz B, Kerz T, Wisser G, Schmidt A, Schneider A, Jahn-Eimermacher A, Werner C, Engelhard K. Prospective assessment of postoperative pain after craniotomy. J Neurosurg Anesthesiol. 2010 Jul;22(3):202-6. doi: 10.1097/ANA.0b013e3181df0600.
citation: Artime CA, Aijazi H, Zhang H, Syed T, Cai C, Gumbert SD, Ferrario L, Normand KC, Williams GW, Hagberg CA. Scheduled Intravenous Acetaminophen Improves Patient Satisfaction With Postcraniotomy Pain Management: A Prospective, Randomized, Placebo-controlled, Double-blind Study. J Neurosurg Anesthesiol. 2018 Jul;30(3):231-236. doi: 10.1097/ANA.0000000000000461.
citation: Licina A, Russell J, Silvers A, Jin X, Denny J. Subcutaneous sumatriptan for the treatment of postcraniotomy pain (SUPS trial): protocol for a randomised double-blinded placebo controlled trial. BMJ Open. 2019 Aug 18;9(8):e032388. doi: 10.1136/bmjopen-2019-032388.
citation: Hassani E, Mahoori A, Sane S, Tolumehr A. Comparison the effects of paracetamol with sufentanil infusion on postoperative pain control after craniotomy in patients with brain tumor. Adv Biomed Res. 2015 Mar 4;4:64. doi: 10.4103/2277-9175.152610. eCollection 2015.