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

Primary Purpose

Postoperative Pain, Lidocaine

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Lidocaine 5% patch

Placebo patch

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Postoperative Pain, Postcraniotomy Pain, Lidocaine Patch

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Beijing Tiantan HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lidocaine Patch

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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'.

Secondary Outcome Measures

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'.

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

Cumulative butorphanol

he cumulative butorphanol consumption through the PCA device

Cumulative intraoperative analgesics consumption

Cumulative intraoperative opioids consumption

Length of hospital stay

Time length from admission to leaving the hospital

Lidocaine 5% plaster safety (local)

Rate of patients with local adverse event as graded using NCI-CTCAE V4.0

Lidocaine 5% plaster safety (systemic)

Rate of patients with systemic adverse event as graded using NCI-CTCAE V4.0

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).

Full Information

NCT ID

NCT04169854

First Posted

November 11, 2019

Last Updated

October 17, 2020

Sponsor

Beijing Tiantan Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04169854

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Unknown status

Study Start Date

October 15, 2020 (Actual)

Primary Completion Date

January 2023 (Anticipated)

Study Completion Date

January 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Beijing Tiantan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain, Lidocaine

Keywords

Postoperative Pain, Postcraniotomy Pain, Lidocaine Patch

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Lidocaine Patch

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Lidocaine 5% patch

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo patch

Intervention Description

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.

Primary Outcome Measure Information:

Title

Pain intensity

Description

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'.

Time Frame

24 hours after craniotomy

Secondary Outcome Measure Information:

Title

Pain intensity

Description

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'.

Time Frame

1, 4, 6, 12, 48 and 72 hours after craniotomy

Title

Time interval to analgesics

Description

Time interval from the end of craniotomy to the first press of the PCA device and to the first rescue analgesic administration

Time Frame

0-72 hours after craniotomy

Title

Cumulative butorphanol

Description

he cumulative butorphanol consumption through the PCA device

Time Frame

24, 48 and 72 hours after craniotomy

Title

Cumulative intraoperative analgesics consumption

Description

Cumulative intraoperative opioids consumption

Time Frame

During the craniotomy

Title

Length of hospital stay

Description

Time length from admission to leaving the hospital

Time Frame

within 3 months

Title

Lidocaine 5% plaster safety (local)

Description

Rate of patients with local adverse event as graded using NCI-CTCAE V4.0

Time Frame

3 preoperative days

Title

Lidocaine 5% plaster safety (systemic)

Description

Rate of patients with systemic adverse event as graded using NCI-CTCAE V4.0

Time Frame

3 preoperative days

Title

Pittsburgh Sleep Quality Index (PSQI)

Description

Time Frame

first 3 days after craniotomy.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Fang Luo, MD

Phone

+8613611326978

13611326978@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fang Luo, MD

Organizational Affiliation

Beijing Tiantan Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beijing Tiantan Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100070

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fang Luo, M.D.

Phone

+86 13611326978

13211326978@163.com

First Name & Middle Initial & Last Name & Degree

Fang Luo, M.D.

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

17410701

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. doi: 10.3171/jns.2007.106.2.210.

Results Reference

background

PubMed Identifier

20479664

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.

Results Reference

background

PubMed Identifier

29117012

Citation

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.

Results Reference

background

PubMed Identifier

31427345

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.

Results Reference

background

PubMed Identifier

25821764

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.

Results Reference

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

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