Skip to main content
OpenTrials
Completed

NCT Number: NCT05920642

Postoperative Pain Relieve for Patients Undergoing Surgical Treatment of Femoral Fracture

The aim of the study is to investigate postoperative pain relief for patients undergoing surgical treatment of proximal femoral fracture using intrathecal administration of morphine.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Proximal Femur Fracture Femoral Fractures Femoral Neck Fractures Fractures, Bone Hip Fractures Hip Injuries Leg Injuries Proximal Femoral Fractures Wounds and Injuries

Age range

60 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

About this study

In this study, the investigators will compare the efficiency of intrathecal morphine administration with the standard of care (parenteral application of analgesics) for pain relief in patients after proximal femoral fracture surgery. The secondary outcome measure will be to determine the frequency of adverse effects of intrathecally administered morphine. The study will be monocentric, randomized, and single-blinded. A total of 50 patients are expected to be enrolled.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • signed informed consent
  • 60 to 90 years of age
  • surgical treatment of proximal femur fracture
  • The American Society of Anesthesiologists (ASA) classification I to III
  • spinal anesthesia used for the operation

Exclusion criteria

  • general anesthesia used for the operation
  • allergy to opioids
  • high risk of respiratory depression

Treatment and study plan

Intrathecal morphine administration

Drug

Administration of morphine into the spinal canal.

Parenteral administration of analgesics

Drug

Standard postoperative pain management of analgesics using parenteral route of administration.

Primary outcomes

  1. Pain assessment

    Time frame: Every 2 hours after the surgery, total of 24 hours

    Pain intensity will be assessed using the Visual Analogue Scale (VAS10) scale (0-10). The total value of all measured values will be calculated. The maximum value observed during the 24 hours will be also recorded.

  2. Pain assessment during patient positioning

    Time frame: 24 hours

    Pain intensity will be assessed using the VAS10 scale (0-10) during the positioning of the patient.

  3. Time to administration of rescue medication

    Time frame: 24 hours

    The time to administration of rescue medication (analgesics) will be observed in hours.

  4. Total consumption of opioids on Intensive Care Unit

    Time frame: 24 hours

    The total consumption of opioids on Intensive Care Unit will be measured in the number of administered doses.

Secondary outcomes

  1. Hypoventilation - bradypnea

    Time frame: 24 hours

    The observed parameters of hypoventilation include bradypnea = respiratory rate (RR)<10/min

  2. Hypoventilation - presence of hypopnea (TV < 4)

    Time frame: 24 hours

    The observed parameters of hypoventilation will include hypopnea = Tidal Volume (TV) < 4 ml/min. It is a physiological parameter that fluctuates depending on the load in the range of 6-180 liters/min.

  3. Hypoventilation - SpO2

    Time frame: 24 hours

    The observed parameters of hypoventilation will include inability to maintain oxygen saturation (SpO2) above 90 % without the need for oxygenotherapy.

  4. Hypoventilation - presence of hypoxemia (paO2) (below 10 kPa)

    Time frame: 24 hours

    The observed parameters of hypoventilation will include hypoxemia according to the analysis of blood gasses. Hypoxemia is diagnosed when the partial pressure of oxygen in the arterial blood (paO2) falls below 10 kiloPascals (kPa).

  5. Hypoventilation - other signs of respiratory insufficiency

    Time frame: 24 hours

    The observed parameters of hypoventilation will include other signs of respiratory insufficiency. Will be evaluated as 0-no, 1-yes + the need for oxygenotherapy, 2-yes+ the need for antidote or other treatment

  6. Hypotension

    Time frame: 24 hours

    The observed parameters of hypotension will be as follows: systolic blood pressure (SBP) < 90 mmHg and/or mean arterial pressure (MAP) < 60 mmHg and/or decrease of blood pressure (BP) by more than 20-30 % of the initial values. Evaluation: 0-no, 1-yes, without administration of noradrenaline, 2-yes, with noradrenaline administration.

  7. Bradycardia

    Time frame: 24 hours

    The observed parameters of bradycardia will be as follows: heart rate (HR) < 50/min. Evaluation: 0-no, 1-yes + administration of atropine or ephedrine, 2-yes+ administration of atropine repeatedly or other treatment.

  8. Postoperative nausea and vomiting

    Time frame: 24 hours

    The incidence of postoperative and vomiting will be observed. Evaluation: 0-no, 1-nausea, 2-vomiting

  9. Effect of antiemetics

    Time frame: 24 hours

    The effect of antiemetics will be observed. Evaluation: 0-not administered, 1-administered, 2-no effect

  10. Pruritus

    Time frame: 24 hours

    The presence and condition of pruritus will be observed. Evaluation: 0-no, 1-yes, no scratching, 2-moderate, need of scratching, 3-strong, need of treatment.

  11. Effect of pruritus treatment

    Time frame: 24 hours

    The effect of pruritus treatment will be observed. Evaluation: 0-no medication administered, 1-administered, 2-no effect

Sponsors and collaborators

Lead sponsor

University Hospital Ostrava

Other

Registry information

Official study title

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)

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 27, 2023
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.