Postoperative Pain in Scheduled Craniotomy

NCT ID: NCT04720248

Last Updated: 2021-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

73 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-24

Study Completion Date

2021-08-15

Brief Summary

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Postoperative pain after craniotomy is frequent, with moderate-severe intensity. The fear to the side effects of opioids (nausea and vomiting and sedation), and NSAIDs (bleeding) makes it difficult to obtain adequate analgesic control in these patients. Preoperative anxiety may be associated with a poorer postoperative analgesic control, hindering the adequate postoperative evolution and increasing hospital stay and adverse effects. In this observational study, the investigators aimed to assess the postoperative analgesic management in patients undergoing scheduled craniotomy following routine clinical practice and to relate preoperative anxiety with the postoperative analgesic evaluation in this population.

Detailed Description

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Postoperative pain after craniotomy is frequent, with moderate-severe intensity. The fear to the side effects of opioids (nausea and vomiting and sedation), and NSAIDs (bleeding) makes it difficult to obtain adequate analgesic control in these patients. On the other hand, preoperative anxiety may be associated with a poorer postoperative analgesic control and hinder the adequate postoperative evolution. The main outcome is to assess the postoperative analgesic management in patients undergoing to craniotomy. Secondary objectives are to evaluate the appearance of postoperative side effects related to the analgesics and to assess the relationship between preoperative anxiety and postoperative pain

Conditions

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Pain, Postoperative Craniotomy Adverse Effect Anxiety

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Metamizol postoperatively

Patients submitted to scheduled craniotomy receiving metamizol as analgesic medication postoperatively

Metamizole

Intervention Type DRUG

Patients will receive metamizole intraoperatively and throughout 48h postoperatively.

Paracetamol or other analgesics postoperatively

Patients submitted to scheduled craniotomy receiving paracetamol or other drugs as analgesic medication postoperatively

No interventions assigned to this group

Interventions

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Metamizole

Patients will receive metamizole intraoperatively and throughout 48h postoperatively.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients over 18 years old undergoing scheduled form for supratentorial craniotomy.
* Signed informed consent.

Exclusion Criteria

* Mini Mental State Examination with a score less than or equal to 24 points.
* Patients suffering from disabilities.
* Patients who can not collaborate in the postoperative clinical assessment.
* Patients who can not be assessed during the postoperative period by the Acute Pain Unit.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr. Negrin University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ángel Becerra

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aurelio Rodríguez Pérez, PhD

Role: STUDY_DIRECTOR

Hospital Universitario de Gran Canaria Doctor Negrín

Ángel Becerra, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario de Gran Canaria Doctor Negrín

Locations

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Ángel Becerra

Las Palmas de Gran Canaria, Las Palmas, Spain

Site Status

Countries

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Spain

Other Identifiers

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Craneo-Negrín

Identifier Type: -

Identifier Source: org_study_id

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