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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metamizol postoperatively | Patients submitted to scheduled craniotomy receiving metamizol as analgesic medication postoperatively |
| |
| Paracetamol or other analgesics postoperatively | Patients submitted to scheduled craniotomy receiving paracetamol or other drugs as analgesic medication postoperatively |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metamizole | Drug | Patients will receive metamizole intraoperatively and throughout 48h postoperatively. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Side effects secondary to metamizol | Rate of appearance of postoperative side effects. | 48 hours postoperatively |
| To assess the correlation between preoperative anxiety and postoperative pain. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ángel Becerra | Las Palmas de Gran Canaria | Las Palmas | 35019 | Spain |
IPD will be decided to be available to other researchers once the study ends.
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D004177 | Dipyrone |
| ID | Term |
|---|---|
| D000632 | Aminopyrine |
| D047069 | Pyrazolones |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 |
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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).
| From the day before surgery to the second day postoperatively |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D001523 | Mental Disorders |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |