NCT04169854

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P50-P75 for phase_3 postoperative-pain

Timeline
Completed

Started Oct 2020

Typical duration for phase_3 postoperative-pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 11, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 20, 2019

Completed
11 months until next milestone

Study Start

First participant enrolled

October 15, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

October 20, 2020

Status Verified

October 1, 2020

Enrollment Period

2.2 years

First QC Date

November 11, 2019

Last Update Submit

October 17, 2020

Conditions

Postoperative PainLidocaine

Keywords

Postoperative PainPostcraniotomy PainLidocaine Patch

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Pain intensity

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

  • Time interval to analgesics

    0-72 hours after craniotomy

  • Cumulative butorphanol

    24, 48 and 72 hours after craniotomy

  • Cumulative intraoperative analgesics consumption

    During the craniotomy

  • Length of hospital stay

    within 3 months

  • +3 more secondary outcomes

Study Arms (2)

Lidocaine Patch

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Lidocaine 5% patchDRUG

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.

Lidocaine Patch
Placebo patchDRUG

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.

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age of 18 or older
  • American Society of Anesthesiologists status I or II
  • Registered for elective craniotomy
  • Informed consent for participation in the trial

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

RECRUITING

Related Publications (6)

  • 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.

    PMID: 17410701BACKGROUND

  • 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.

    PMID: 20479664BACKGROUND

  • 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.

    PMID: 29117012BACKGROUND

  • 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.

    PMID: 31427345BACKGROUND

  • 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.

    PMID: 25821764BACKGROUND

  • Han X, Yang Y, Ren T, Ji N, Luo F. Efficacy of Preemptive Topical Lidocaine 5% Plaster in the Prevention of Post-Craniotomy Pain, a Randomized Clinical Trial. J Pain Res. 2024 Dec 13;17:4251-4261. doi: 10.2147/JPR.S499264. eCollection 2024.

    PMID: 39691748DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

LidocaineTransdermal Patch

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesEquipment and Supplies

Study Officials

  • Fang Luo, MD

    Beijing Tiantan Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fang Luo, MD

CONTACT

+861361132697813611326978@163.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

November 11, 2019

First Posted

November 20, 2019

Study Start

October 15, 2020

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

October 20, 2020

Record last verified: 2020-10

Locations

CN(1)