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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04169854
Other study ID # KY 2019-122-02
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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.
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