Proximal Femur Fracture
Conditions
Keywords
proximal femur fracture, morphine administration, pain relief, intrathecal administration, parenteral administration, surgery
Brief summary
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.
Detailed description
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.
Interventions
DRUGIntrathecal morphine administration
Administration of morphine into the spinal canal.
Standard postoperative pain management of analgesics using parenteral route of administration.
Sponsors
University Hospital Ostrava
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
The participant will not know which arm of the study he/she has been enrolled into.
Intervention model description
The study subjects will be randomized into two parallel groups.
Eligibility
Sex/Gender
ALL
Age
60 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain assessment | 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. |
| Pain assessment during patient positioning | 24 hours | Pain intensity will be assessed using the VAS10 scale (0-10) during the positioning of the patient. |
| Time to administration of rescue medication | 24 hours | The time to administration of rescue medication (analgesics) will be observed in hours. |
| Total consumption of opioids on Intensive Care Unit | 24 hours | The total consumption of opioids on Intensive Care Unit will be measured in the number of administered doses. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hypoventilation - other signs of respiratory insufficiency | 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 |
| Hypotension | 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. |
| Bradycardia | 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. |
| Hypoventilation - bradypnea | 24 hours | The observed parameters of hypoventilation include bradypnea = respiratory rate (RR)\<10/min |
| Effect of antiemetics | 24 hours | The effect of antiemetics will be observed. Evaluation: 0-not administered, 1-administered, 2-no effect |
| Pruritus | 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. |
| Effect of pruritus treatment | 24 hours | The effect of pruritus treatment will be observed. Evaluation: 0-no medication administered, 1-administered, 2-no effect |
| Postoperative nausea and vomiting | 24 hours | The incidence of postoperative and vomiting will be observed. Evaluation: 0-no, 1-nausea, 2-vomiting |
| Hypoventilation - presence of hypopnea (TV < 4) | 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. |
| Hypoventilation - SpO2 | 24 hours | The observed parameters of hypoventilation will include inability to maintain oxygen saturation (SpO2) above 90 % without the need for oxygenotherapy. |
| Hypoventilation - presence of hypoxemia (paO2) (below 10 kPa) | 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). |
Countries
Czechia
Outcome results
None listed