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Postoperative Pain in Scheduled Craniotomy

Valoración Del Dolor Postoperatorio en Pacientes Sometidos a craneotomía Programada

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04720248
Enrollment
73
Registered
2021-01-22
Start date
2021-02-24
Completion date
2021-08-15
Last updated
2021-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative, Craniotomy, Adverse Effect, Anxiety

Keywords

postoperative pain, neurosurgery, craniotomy, anxiety

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

Interventions

Patients will receive metamizole intraoperatively and throughout 48h postoperatively.

Sponsors

Dr. Negrin University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Postoperative pain48 hours postoperativelyUsing 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

MeasureTime frameDescription
Side effects secondary to metamizol48 hours postoperativelyRate of appearance of postoperative side effects.
To assess the correlation between preoperative anxiety and postoperative pain.From the day before surgery to the second day postoperativelyRelate the score obtained in the State Anxiety Inventory Trait (STAI) (from 0 to 60) with the intensity of postoperative pain (from 0 to 10).

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026