Postoperative Pain in Scheduled Craniotomy

N/ACompletedNCT04720248

Dr. Negrin University Hospital73 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Pain, Postoperative Craniotomy Adverse Effect Anxiety

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

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