Postoperative Pain in Scheduled Craniotomy

Anxiety Clinical Trial

Official title:

Valoración Del Dolor Postoperatorio en Pacientes Sometidos a craneotomía Programada

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04720248
• Other study ID #: Craneo-Negrín
• Status: Completed
• Start date: February 24, 2021
• Est. completion date: August 15, 2021

Study information

• Verified date: August 2021
• Source: Dr. Negrin University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: August 15, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adverse Effect
• Anxiety
• Craniotomy
• Pain, Postoperative

Intervention

Drug:
• Metamizole
Patients will receive metamizole intraoperatively and throughout 48h postoperatively.

Locations

Country	Name	City	State
Spain	Ángel Becerra	Las Palmas De Gran Canaria	Las Palmas

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Negrin University Hospital

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Side effects secondary to metamizol	Rate of appearance of postoperative side effects.	48 hours postoperatively
Secondary	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