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, Randomized Clinical Study Compared to Standard Treatment)

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.

proximal femur fracture, morphine administration, pain relief, intrathecal administration, parenteral administration, surgery

Study subjects randomized into this arm will be administered morphine intrathecally in the dose of dose 100 ug.

Study subjects randomized into this arm will receive standard postoperative pain management (parenteral administration of analgesics).

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.

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

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.

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

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).

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

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.

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.

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

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.

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

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

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