The effect of perioperative intravenous s-ketamine on acute and chronic postoperative craniotomy pain compared to placebo
- Conditions
- 1001923110009720headache after brainsurgerypost operative craniotomy pain
- Registration Number
- NL-OMON53141
- Lead Sponsor
- Medisch Universitair Ziekenhuis Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 62
- Age > 18 years
- Elective resective surgery for drug-resistant temporal lobe epilepsy
- Drug-resistant epilepsy, based on: (1) chronic, focal epilepsy; (2) not
seizure free with antiepileptic medication; (3) no medication options due to
adverse effects
- Signed informed consent for trial participation
- Declined informed consent
- Allergy to any of the trial medications
- Current chronic pain, such as, but not limiting to, migraine or other
headaches.
- Chronic pain treatment with use of different kinds of pain medication.
- Alcohol, hard- or soft drug abuses
- Inability to complete questionnaires or language barrier
- History of psychiatric complaints for which treatment was performed
- History of craniotomy or subdural electrode implantation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoint is the total postoperative opioid consumption at the 7th<br /><br>postoperative day with interim measurements at 24, 48, 72 and 96 hours. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints are the postoperative pain scores (VAS+NRS), patient<br /><br>health-related quality of life, psychological parameters, length of hospital<br /><br>stay and adverse events. </p><br>