An observational study in Pain, Postoperative, Craniotomy and Adverse Effect, sponsored by Dr. Negrin University Hospital. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-18.
Sponsored by Dr. Negrin University Hospital · Observational
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
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 73 is below the median of 102 across 608 observational studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Dr. Negrin University Hospital is the lead sponsor of 19 studies on the registry; 2 are open to participants now.
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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.
Exclusion Criteria:
Patients submitted to scheduled craniotomy receiving metamizol as analgesic medication postoperatively
Drug: Metamizole
Patients submitted to scheduled craniotomy receiving paracetamol or other drugs as analgesic medication postoperatively
Patients will receive metamizole intraoperatively and throughout 48h postoperatively.
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).
Time frame: 48 hours postoperatively
Side effects secondary to metamizol
Rate of appearance of postoperative side effects.
Time frame: 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).
Time frame: From the day before surgery to the second day postoperatively
Plan to share: Undecided — IPD will be decided to be available to other researchers once the study ends.
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This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Dr. Negrin University Hospital