Risk-benefit analysis of intrathecal morphine administration to patients undergoing surgical treatment of proximal femoral fracture (monocentric, single-blinded, randomized clinical study compared to standard treatment)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-513996-42-00

Enrollment

100

Registered

2024-10-31

Start date

Unknown

Completion date

2025-09-30

Last updated

2024-10-31

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

Conditions

proximal femur fracture

Brief summary

pain assessment using VAS10 at rest (value 0-10 according to pain intensity, measured every 2 h for 24 h), pain assessment using VAS10 while positioning the patient, time until the first administration of rescue medication – analgesics, total consumption of opioids in the ICU per 24 h, the dose of administered non-opioid analgesics

Detailed description

monitoring of hypoventilation, monitoring of hypotension, monitoring of bradycardia, postoperative nausea and vomiting, effect of antiemetic mediation, monitoring of pruritus, the effectiveness of the treatment of pruritus

Interventions

DRUGMORPHINE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
pain assessment using VAS10 at rest (value 0-10 according to pain intensity, measured every 2 h for 24 h), pain assessment using VAS10 while positioning the patient, time until the first administration of rescue medication – analgesics, total consumption of opioids in the ICU per 24 h, the dose of administered non-opioid analgesics	—

Secondary

Measure	Time frame
monitoring of hypoventilation, monitoring of hypotension, monitoring of bradycardia, postoperative nausea and vomiting, effect of antiemetic mediation, monitoring of pruritus, the effectiveness of the treatment of pruritus	—

Countries

Czechia

Outcome results

None listed

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