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OpenTrials
Completed

NCT Number: NCT04720248

Postoperative Pain in Scheduled Craniotomy

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.

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Key information

Conditions

Pain, Postoperative Adverse Effect Anxiety Anxiety Disorders Craniotomy Mental Disorders Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ángel Becerra

Las Palmas de Gran Canaria, Las Palmas, 35019, Spain

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Metamizole

Drug

Patients will receive metamizole intraoperatively and throughout 48h postoperatively.

Primary outcomes

  1. Postoperative pain

    Time frame: 48 hours postoperatively

    Using the Visual Analgesic Scale (from 0 to 10, with 0 being the state corresponding to "no pain" and 10 being the "maximum pain imaginable ") and postoperative analgesic satisfaction assessed by the patient (stratified in Bad, Fair, Good or Excellent).

Secondary outcomes

  1. Side effects secondary to metamizol

    Time frame: 48 hours postoperatively

    Rate of appearance of postoperative side effects.

  2. To assess the correlation between preoperative anxiety and postoperative pain.

    Time frame: From the day before surgery to the second day postoperatively

    Relate the score obtained in the State Anxiety Inventory Trait (STAI) (from 0 to 60) with the intensity of postoperative pain (from 0 to 10).

Sponsors and collaborators

Lead sponsor

Hospital Universitario de Gran Canaria Doctor Negrín

Other

Registry information

Official study title

Valoración Del Dolor Postoperatorio en Pacientes Sometidos a craneotomía Programada

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 22, 2021
Registry last updated
Aug 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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