Postoperative pain relieve for patients undergoing surgical treatment of femoral fracture

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-002765-17-CZ

Enrollment

Registered

2021-05-28

Start date

2023-08-17

Completion date

Unknown

Last updated

2024-10-21

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

Conditions

Postoperative pain relieve MedDRA version: 21.1 Level: LLT Classification code 10036236 Term: Postoperative pain relief System Organ Class: 100000004865

Interventions

Product Name: Morphini hydrochloridum Pharmaceutical Form: Solution for injection INN or Proposed INN: morphini hydrochloridum CAS Number: 52-26-6 Other descriptive name: MORPHINE HYDROCHLORIDE Concen

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. signed informed consent 2. male and female 3. 60 to 90 years of age 4. surgical treatment of proximal femure fracture 5. ASA classification I to III 6. spinal anaesthesia used for the operation Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

Exclusion criteria: 1. general anaesthesia used for the operation 2. allergy for the opioids 3. high risk of respiratory depression

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare efficiency of intrathecal morphin administration with standard of care (parenteral application of analgesic);Secondary Objective: To compare safety of intrathecal morphin administration with standard of care (parenteral application of analgesic);Primary end point(s): 1. Mean VAS score at rest every 2 hours after administration for 24 hours 2. Time to use a rescue medication. 3. Total dose of opioids for 24 hours 4. Count of non-opioid analgesics for 24 hours.;Timepoint(s) of evaluation of this end point: 24 hours after admission to intensive care unit after surgery.	—

Measure

Time frame

Main Objective: To compare efficiency of intrathecal morphin administration with standard of care (parenteral application of analgesic);Secondary Objective: To compare safety of intrathecal morphin administration with standard of care (parenteral application of analgesic);Primary end point(s): 1. Mean VAS score at rest every 2 hours after administration for 24 hours 2. Time to use a rescue medication. 3. Total dose of opioids for 24 hours 4. Count of non-opioid analgesics for 24 hours.;Timepoint(s) of evaluation of this end point: 24 hours after admission to intensive care unit after surgery.

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Secondary

Measure	Time frame
Secondary end point(s): 1. Incidence and severity of hypoventilation. 2. Incidence and severity of hypotension. 3. Incidence and severity of bradycardia. 4. Incidence and severity of nausea and vomiting. 5. Incidence and severity of pruritus. 6. The effect of treatment for nausea and vomiting. 7. The effect of treatment for pruritus.;Timepoint(s) of evaluation of this end point: 24 hours after admission to intensive care unit after surgery.	—

Measure

Time frame

Secondary end point(s): 1. Incidence and severity of hypoventilation. 2. Incidence and severity of hypotension. 3. Incidence and severity of bradycardia. 4. Incidence and severity of nausea and vomiting. 5. Incidence and severity of pruritus. 6. The effect of treatment for nausea and vomiting. 7. The effect of treatment for pruritus.;Timepoint(s) of evaluation of this end point: 24 hours after admission to intensive care unit after surgery.

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Countries

Czech Republic

Contacts

Public ContactJirí Havrlant

Fakultní nemocnice Ostrava

00420597372281

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026