The effect of perioperative intravenous s-ketamine on acute and chronic postoperative craniotomy pain compared to placebo: a prospective randomized double blind placebo controlled trial (ESPAIN-trial)

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-514020-16-00

Enrollment

Registered

2024-12-13

Start date

2018-03-14

Completion date

Unknown

Last updated

2024-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-craniotomy headache

Brief summary

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.

Detailed description

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.

Interventions

DRUGESKETAMINE

DRUGSODIUM CHLORIDE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026