Postoperative Pain in Scheduled Craniotomy

Completed

• Conditions: Pain, Postoperative; Craniotomy; Adverse Effect; Anxiety
• Interventions: Drug: Metamizole

• Registration Number: NCT04720248
• Lead Sponsor: Dr. Negrin University Hospital

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.

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 Timeline

• Study First Submitted: 2021-01-19
• Study First Submitted QC: 2021-01-21
• Study First Posted: 2021-01-22
• Study Start: 2021-02-24
• Primary Completion: 2021-06-30
• Status Verified: 2021-08
• Study Completion: 2021-08-15
• Last Update Submitted: 2021-08-17
• Last Update Posted: 2021-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Metamizol postoperatively	Metamizole	Patients submitted to scheduled craniotomy receiving metamizol as analgesic medication postoperatively

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).

Trial Locations

Locations (1)

Ángel Becerra; 🇪🇸 Las Palmas De Gran Canaria, Las Palmas, Spain