Pre- vs. Postoperative Scalp Block for Pain Control After Supratentorial Craniotomy

April 14, 2020 updated by: Federico Bilotta, University of Roma La Sapienza
Study was designed to evaluate optimal timing for selective scalp block in patients undergoing general anesthesia for supratentorial craniotomy.Pain score assessed by visual analog scale (VAS) preoperatively (baseline) and after extubation at 2, 6, 12 and 24 hours; time first request of a patient for rescue analgesia; intraoperative anesthetics and opioids consumption; awakening time; perioperative complications.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

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:

  • Adult patients (>18 years),
  • presenting with supratentorial brain tumors scheduled for elective craniotomy under general anesthesia

Exclusion Criteria:

  • history of allergic reactions on local anesthetics;
  • ASA status ≥ 3;
  • depressed consciousness in pre- or postoperative period;
  • aphasia (as investigators were not able to obtain VAS score).

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: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale score at 24 h after surgery
Time Frame: up to 24 hours
Visual Analogue Scale ranging from 0 (no pain) to 10 (worst imaginable pain),
up to 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale score at 0
Time Frame: Baseline
Visual Analogue Scale ranging from 0 (no pain) to 10 (worst imaginable pain)
Baseline
Visual Analogue Scale score at 2 hours
Time Frame: up to 2 hours
Visual Analogue Scale ranging from 0 (no pain) to 10 (worst imaginable pain)
up to 2 hours
Visual Analogue Scale score at 6 hours
Time Frame: up to 6 hours
Visual Analogue Scale ranging from 0 (no pain) to 10 (worst imaginable pain)
up to 6 hours
Visual Analogue Scale score at 12 hours
Time Frame: up to 12 hours
Visual Analogue Scale ranging from 0 (no pain) to 10 (worst imaginable pain)
up to 12 hours
time first request of a patient for rescue analgesia
Time Frame: during surgery
during surgery
intraoperative anesthetics
Time Frame: during surgery time
(and opioids consumption)
during surgery time
awakening time
Time Frame: time from the end of surgery to awekening
time from the end of surgery to awekening
changes in hemodynamics at mayfiled headfraom positioning
Time Frame: surgery
changes in term of blood pressure
surgery
changes in hemodynamics at mayfiled headfraom positioning
Time Frame: surgery
changes in heart rate
surgery

Collaborators and Investigators

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

Sponsor

University of Roma La Sapienza

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 (ANTICIPATED)

April 20, 2020

Primary Completion (ANTICIPATED)

November 30, 2020

Study Completion (ANTICIPATED)

December 30, 2020

Study Registration Dates

First Submitted

March 30, 2020

First Submitted That Met QC Criteria

April 13, 2020

First Posted (ACTUAL)

April 14, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 15, 2020

Last Update Submitted That Met QC Criteria

April 14, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • URom

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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