Clinical trial NCT04720248: Postoperative Pain in Scheduled Craniotomy
Official title: Valoración Del Dolor Postoperatorio en Pacientes Sometidos a craneotomía Programada
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain, Postoperative
Craniotomy
Adverse Effect
Anxiety
Keywords: postoperative pain
neurosurgery
craniotomy
anxiety
Lead sponsor: Dr. Negrin University Hospital
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: 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

Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative pain
timeFrame: 48 hours postoperatively
Secondary outcomes:
measure: Side effects secondary to metamizol
timeFrame: 48 hours postoperatively
measure: To assess the correlation between preoperative anxiety and postoperative pain.
timeFrame: From the day before surgery to the second day postoperatively
Other outcomes:
Locations:
city: Las Palmas De Gran Canaria
country: Spain
facility: Ángel Becerra
state: Las Palmas
Study officials:
affiliation: Hospital Universitario de Gran Canaria Doctor Negrín
name: Aurelio Rodríguez Pérez, PhD
role: STUDY_DIRECTOR
affiliation: Hospital Universitario de Gran Canaria Doctor Negrín
name: Ángel Becerra, MD
role: PRINCIPAL_INVESTIGATOR
References: