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

October 17, 2020 updated by: Fang Luo, Beijing Tiantan Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100070
        • Recruiting
        • Beijing Tiantan Hospital
        • Contact:
        • Principal Investigator:
          • Fang Luo, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lidocaine Patch
Surgeons will be asked to mark the planned incisions site 3 days before craniotomy. The masked Lidocaine 5% patch will be applied to cover the insicion mark as well as the head-holders sites within 6:00 P.M. to 6:00 A.M. for 3 consecutive preoperative days.
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 Comparator: Placebo
Surgeons will be asked to mark the planned incisions site 3 days before craniotomy. The masked placebo patch will be applied to cover the insicion mark as well as the head-holders sites within 6:00 P.M. to 6:00 A.M. for 3 consecutive preoperative days.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: 24 hours after craniotomy
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: 1, 4, 6, 12, 48 and 72 hours after craniotomy
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
Time interval to analgesics
Time Frame: 0-72 hours after craniotomy
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
Cumulative butorphanol
Time Frame: 24, 48 and 72 hours after craniotomy
he cumulative butorphanol consumption through the PCA device
24, 48 and 72 hours after craniotomy
Cumulative intraoperative analgesics consumption
Time Frame: During the craniotomy
Cumulative intraoperative opioids consumption
During the craniotomy
Length of hospital stay
Time Frame: within 3 months
Time length from admission to leaving the hospital
within 3 months
Lidocaine 5% plaster safety (local)
Time Frame: 3 preoperative days
Rate of patients with local adverse event as graded using NCI-CTCAE V4.0
3 preoperative days
Lidocaine 5% plaster safety (systemic)
Time Frame: 3 preoperative days
Rate of patients with systemic adverse event as graded using NCI-CTCAE V4.0
3 preoperative days
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: first 3 days after craniotomy.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tiantan Hospital

Investigators

  • Principal Investigator: Fang Luo, MD, Beijing Tiantan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2020

Primary Completion (Anticipated)

January 1, 2023

Study Completion (Anticipated)

January 1, 2023

Study Registration Dates

First Submitted

November 11, 2019

First Submitted That Met QC Criteria

November 17, 2019

First Posted (Actual)

November 20, 2019

Study Record Updates

Last Update Posted (Actual)

October 20, 2020

Last Update Submitted That Met QC Criteria

October 17, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY 2019-122-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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