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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
82
Administration of morphine into the spinal canal.
Standard postoperative pain management of analgesics using parenteral route of administration.
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, Czechia
Pain assessment
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.
Time frame: Every 2 hours after the surgery, total of 24 hours
Pain assessment during patient positioning
Pain intensity will be assessed using the VAS10 scale (0-10) during the positioning of the patient.
Time frame: 24 hours
Time to administration of rescue medication
The time to administration of rescue medication (analgesics) will be observed in hours.
Time frame: 24 hours
Total consumption of opioids on Intensive Care Unit
The total consumption of opioids on Intensive Care Unit will be measured in the number of administered doses.
Time frame: 24 hours
Hypoventilation - bradypnea
The observed parameters of hypoventilation include bradypnea = respiratory rate (RR)\<10/min
Time frame: 24 hours
Hypoventilation - presence of hypopnea (TV < 4)
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.
Time frame: 24 hours
Hypoventilation - SpO2
The observed parameters of hypoventilation will include inability to maintain oxygen saturation (SpO2) above 90 % without the need for oxygenotherapy.
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Time frame: 24 hours
Hypoventilation - presence of hypoxemia (paO2) (below 10 kPa)
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).
Time frame: 24 hours
Hypoventilation - other signs of respiratory insufficiency
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
Time frame: 24 hours
Hypotension
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.
Time frame: 24 hours
Bradycardia
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.
Time frame: 24 hours
Postoperative nausea and vomiting
The incidence of postoperative and vomiting will be observed. Evaluation: 0-no, 1-nausea, 2-vomiting
Time frame: 24 hours
Effect of antiemetics
The effect of antiemetics will be observed. Evaluation: 0-not administered, 1-administered, 2-no effect
Time frame: 24 hours
Pruritus
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.
Time frame: 24 hours
Effect of pruritus treatment
The effect of pruritus treatment will be observed. Evaluation: 0-no medication administered, 1-administered, 2-no effect
Time frame: 24 hours