Postoperative Pain in Scheduled Craniotomy

NCT04720248 | Completed DMC FDA Drug

• 1 other identifier: Craneo-Negrín
• Study Type: observational
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain, Postoperative; Craniotomy; Adverse Effect; Anxiety

Keywords

postoperative pain; neurosurgery; craniotomy; anxiety

Outcome Measures

Primary Outcomes (1)

• Postoperative pain

  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).

  48 hours postoperatively

Secondary Outcomes (2)

• Side effects secondary to metamizol

  48 hours postoperatively

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

  From the day before surgery to the second day postoperatively

Study Arms (2)

Metamizol postoperatively

Patients submitted to scheduled craniotomy receiving metamizol as analgesic medication postoperatively

Drug: Metamizole

Paracetamol or other analgesics postoperatively

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

Interventions

Metamizole DRUG

Patients will receive metamizole intraoperatively and throughout 48h postoperatively.

Metamizol postoperatively

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients over 18 years old undergoing scheduled form for supratentorial craniotomy during the 8 months following the beginning of study at the center who can give informed consent and can be postoperatively evaluated by the acute pain unit.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Negrin University Hospital: lead

Study Sites (1)

Ángel Becerra

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

Location

MeSH Terms

Conditions

Pain, Postoperative; Anxiety Disorders

Interventions

Dipyrone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Aminopyrine; Pyrazolones; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Aurelio Rodríguez Pérez, PhD

  Hospital Universitario de Gran Canaria Doctor Negrín

  STUDY DIRECTOR

• Ángel Becerra, MD

  Hospital Universitario de Gran Canaria Doctor Negrín

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: January 22, 2021
• Study Start: February 24, 2021
• Primary Completion: June 30, 2021
• Study Completion: August 15, 2021
• Last Updated: August 18, 2021

Record last verified: 2021-08

Locations

ES (1)