Postoperative Pain in Scheduled Craniotomy

Valoración Del Dolor Postoperatorio en Pacientes Sometidos a craneotomía Programada

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Anxiety; Craniotomy; Adverse Effect
• Intervention / Treatment: Drug: Metamizole

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 Type: Observational
• Enrollment (Actual): 73

Contacts and Locations

Study Locations

• Spain
  • Las Palmas
    • Las Palmas De Gran Canaria, Las Palmas, Spain, 35019
      • Ángel Becerra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Side effects secondary to metamizol	Rate of appearance of postoperative side effects.	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).	From the day before surgery to the second day postoperatively

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start (ACTUAL): February 24, 2021
• Primary Completion (ACTUAL): June 30, 2021
• Study Completion (ACTUAL): August 15, 2021

Study Registration Dates

• First Submitted: January 19, 2021
• First Submitted That Met QC Criteria: January 21, 2021
• First Posted (ACTUAL): January 22, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 18, 2021
• Last Update Submitted That Met QC Criteria: August 17, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: anxiety; postoperative pain; neurosurgery; craniotomy
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antipyretics; Dipyrone
• Other Study ID Numbers: Craneo-Negrín

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: IPD will be decided to be available to other researchers once the study ends.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No