Postoperative Pain in Scheduled Craniotomy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Metamizol postoperatively Patients submitted to scheduled craniotomy receiving metamizol as analgesic medication postoperatively |
Drug: Metamizole
Patients will receive metamizole intraoperatively and throughout 48h postoperatively.
|
| Paracetamol or other analgesics postoperatively Patients submitted to scheduled craniotomy receiving paracetamol or other drugs as analgesic medication postoperatively |
Outcome Measures
Primary Outcome Measures
- Postoperative pain [48 hours postoperatively]
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).
Secondary Outcome Measures
- Side effects secondary to metamizol [48 hours postoperatively]
Rate 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 postoperatively]
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).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients over 18 years old undergoing scheduled form for supratentorial craniotomy.
-
Signed informed consent.
Exclusion Criteria:
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Mini Mental State Examination with a score less than or equal to 24 points.
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Patients suffering from disabilities.
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Patients who can not collaborate in the postoperative clinical assessment.
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Patients who can not be assessed during the postoperative period by the Acute Pain Unit.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ángel Becerra | Las Palmas De Gran Canaria | Las Palmas | Spain | 35019 |
Sponsors and Collaborators
- Dr. Negrin University Hospital
Investigators
- Study Director: Aurelio Rodríguez Pérez, PhD, Hospital Universitario de Gran Canaria Doctor Negrín
- Principal Investigator: Ángel Becerra, MD, Hospital Universitario de Gran Canaria Doctor Negrín
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Craneo-Negrín