NCT02880566

Brief Summary

Prospective randomised double-blinded placebo-controlled trial on the efficacy of scalp blocks on hemodynamic stability and opioid consumption during and after craniotomy.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2016

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

August 23, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 26, 2016

Completed
6 days until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

August 26, 2016

Status Verified

August 1, 2016

Enrollment Period

1 year

First QC Date

August 23, 2016

Last Update Submit

August 23, 2016

Conditions

Craniotomy

Outcome Measures

Primary Outcomes (1)

  • Hemodynamic stability

    Increased in mean arterial pressure or heart rate of more than 15 % within 5 minutes of head pinning

    5 minutes

Secondary Outcomes (3)

  • Cumulative intraoperative remifentanil consumption

    24 hours

  • Cumulative postoperative morphine consumption

    48 hours

  • Postoperative pain scores

    48 hours

Study Arms (2)

Treatment

EXPERIMENTAL

Full scalp block performed with a total of 30 ml of levobupivacaine 0.33 %.

Procedure: Scalp block

Control

PLACEBO COMPARATOR

Full scalp block performed with a total of 30 ml of normal saline.

Procedure: Scalp block

Interventions

Scalp blockPROCEDURE

Full scalp block

ControlTreatment

Eligibility Criteria

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

You may qualify if:

  • Elective craniotomy for supratentorial lesion

You may not qualify if:

  • Allergy to local anaesthetic
  • Psychiatric disease
  • Inability to consent
  • Uncontrolled intracranial hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Carella M, Tran G, Bonhomme VL, Franssen C. Influence of Levobupivacaine Regional Scalp Block on Hemodynamic Stability, Intra- and Postoperative Opioid Consumption in Supratentorial Craniotomies: A Randomized Controlled Trial. Anesth Analg. 2021 Feb 1;132(2):500-511. doi: 10.1213/ANE.0000000000005230.

    PMID: 33060491DERIVED

Study Design

Study Type
interventional
Phase
not applicable
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
Professor and Chair

Study Record Dates

First Submitted

August 23, 2016

First Posted

August 26, 2016

Study Start

September 1, 2016

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

August 26, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share