NCT04720248

Postoperative Pain in Scheduled Craniotomy

Valoración Del Dolor Postoperatorio en Pacientes Sometidos a craneotomía Programada

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 73 (actual)
• Sponsor: Dr. Negrin University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Pain, Postoperative
• Craniotomy
• Adverse Effect
• Anxiety

Interventions

Type	Name	Description
DRUG	Metamizole	Patients will receive metamizole intraoperatively and throughout 48h postoperatively.

Timeline

• Start date: 2021-02-24
• Primary completion: 2021-06-30
• Completion: 2021-08-15
• First posted: 2021-01-22
• Last updated: 2021-08-18

Locations

1 site across 1 country: Spain

Regulatory

• FDA-regulated drug study