Postoperative Pain Clinical Trial
— EASYOfficial title:
Pre-emptive Topical Lidocaine 5% Plaster for Prevention of Post-craniotomy Pain : a Protocol for a Randomized, Triple Blind, Placebo-controlled Trail
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.
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 |
Country | Name | City | State |
---|---|---|---|
China | Beijing Tiantan Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Beijing Tiantan Hospital |
China,
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
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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