Postoperative Pain in Scheduled Craniotomy

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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

Official Title
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Valoración Del Dolor Postoperatorio en Pacientes Sometidos a craneotomía Programada

Conditions
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Pain, Postoperative, Craniotomy, Adverse Effect, Anxiety

Intervention / Treatment
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* Drug: Metamizole


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Metamizol postoperatively<br>Patients submitted to scheduled craniotomy receiving metamizol as analgesic medication postoperatively | Drug: Metamizole<br>* Patients will receive metamizole intraoperatively and throughout 48h postoperatively.<br>|
| Paracetamol or other analgesics postoperatively<br>Patients submitted to scheduled craniotomy receiving paracetamol or other drugs as analgesic medication postoperatively | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postoperative pain, neurosurgery, craniotomy, anxiety