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

Postoperative Pain Clinical Trial

— EASY  

Official title:

Pre-emptive Topical Lidocaine 5% Plaster for Prevention of Post-craniotomy Pain : a Protocol for a Randomized, Triple Blind, Placebo-controlled Trail

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04169854
• Other study ID #: KY 2019-122-02
• Status: Recruiting
• Phase: Phase 3
• Start date: October 15, 2020
• Est. completion date: January 2023

Study information

• Verified date: October 2020
• Source: Beijing Tiantan Hospital
• Contact: Fang Luo, MD
• Phone: +8613611326978
• Email: 13611326978[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: January 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lidocaine
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Lidocaine 5% patch
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.
• Placebo 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.

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View Citation

Gottschalk A, Berkow LC, Stevens RD, Mirski M, Thompson RE, White ED, Weingart JD, Long DM, Yaster M. Prospective evaluation of pain and analgesic use following major elective intracranial surgery. J Neurosurg. 2007 Feb;106(2):210-6. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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'.	24 hours after craniotomy
Secondary	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'.	1, 4, 6, 12, 48 and 72 hours after craniotomy
Secondary	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	0-72 hours after craniotomy
Secondary	Cumulative butorphanol	he cumulative butorphanol consumption through the PCA device	24, 48 and 72 hours after craniotomy
Secondary	Cumulative intraoperative analgesics consumption	Cumulative intraoperative opioids consumption	During the craniotomy
Secondary	Length of hospital stay	Time length from admission to leaving the hospital	within 3 months
Secondary	Lidocaine 5% plaster safety (local)	Rate of patients with local adverse event as graded using NCI-CTCAE V4.0	3 preoperative days
Secondary	Lidocaine 5% plaster safety (systemic)	Rate of patients with systemic adverse event as graded using NCI-CTCAE V4.0	3 preoperative days
Secondary	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).	first 3 days after craniotomy.