The effect of perioperative intravenous s-ketamine on acute and chronic postoperative craniotomy pain compared to placebo

Phase 4

Recruiting

Conditions: Post-craniotomy headache

Registration Number: 2024-514020-16-00

Lead Sponsor: Academisch Ziekenhuis Maastricht

Brief Summary: The aim of this study is to investigate the effect of adding s-ketamine to a multimodal pain approach of acetaminophen and opioids compared to placebo with the same multimodal pain approach, on total opioid consumption after craniotomy in patients with drug-resistant temporal lobe epilepsy. The total opioid consumption will be measured 5 times in the first 7 days after operation.

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised, recruiting

Sex: Not specified

Target Recruitment: 62

Inclusion Criteria

Age > 18 years

Elective resective surgery for drug-resistant temporal lobe epilepsy

Drug-resistant epilepsy, based on: o chronic, focal epilepsy o not seizure free with antiepileptic medication o no medication options due to adverse effects

Signed informed consent for trial participation

Exclusion Criteria

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: Not specified

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is the total postoperative opioid consumption at the 7th postoperative day with interim measurements at 24, 48, 72 and 96 hours postoperatively.		The primary endpoint is the total postoperative opioid consumption at the 7th postoperative day with interim measurements at 24, 48, 72 and 96 hours postoperatively.

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints will be the length of hospital stay, patient health-related quality of life (RAND SF-36 questionnaire), psychological parameters (questionnaires below cited), adverse events, and postoperative pain scores (VAS+NRS) during the first 7 postoperative days.		Secondary endpoints will be the length of hospital stay, patient health-related quality of life (RAND SF-36 questionnaire), psychological parameters (questionnaires below cited), adverse events, and postoperative pain scores (VAS+NRS) during the first 7 postoperative days.

Trial Locations

Locations (1): Maastricht University Medical Center+
🇳🇱
Maastricht, Netherlands
Maastricht University Medical Center+
🇳🇱Maastricht, Netherlands
Olaf Schijns
Site contact
0433876502
o.schijns@mumc.nl