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

NCT04169854 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2020-10-20

No results posted yet for this study

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.

Conditions

  • Postoperative Pain
  • Lidocaine

Interventions

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.

DRUG

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.

Sponsors & Collaborators

  • Beijing Tiantan Hospital

    lead OTHER

Principal Investigators

  • Fang Luo, MD · Beijing Tiantan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-15
Primary Completion
2023-01-31
Completion
2023-01-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04169854 on ClinicalTrials.gov