Postoperative Pain Relieve for Patients Undergoing Surgical Treatment of Femoral Fracture

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Proximal Femur Fracture

Intervention / Treatment
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* Drug: Intrathecal morphine administration
* Drug: Parenteral administration of analgesics


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study subjects will be randomized into two parallel groups.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intrathecal morphine administration<br>Study subjects randomized into this arm will be administered morphine intrathecally in the dose of dose 100 ug. | Drug: Intrathecal morphine administration<br>* Administration of morphine into the spinal canal.<br>|
| Active Comparator: Parenteral administration of analgesics<br>Study subjects randomized into this arm will receive standard postoperative pain management (parenteral administration of analgesics). | Drug: Parenteral administration of analgesics<br>* Standard postoperative pain management of analgesics using parenteral route of administration.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 24 hours | 
| Time to administration of rescue medication | The time to administration of rescue medication (analgesics) will be observed in hours. | 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. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoventilation - bradypnea | The observed parameters of hypoventilation include bradypnea = respiratory rate (RR)<10/min | 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. | 24 hours | 
| Hypoventilation - SpO2 | The observed parameters of hypoventilation will include inability to maintain oxygen saturation (SpO2) above 90 % without the need for oxygenotherapy. | 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). | 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 | 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. | 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. | 24 hours | 
| Postoperative nausea and vomiting | The incidence of postoperative and vomiting will be observed. Evaluation: 0-no, 1-nausea, 2-vomiting | 24 hours | 
| Effect of antiemetics | The effect of antiemetics will be observed. Evaluation: 0-not administered, 1-administered, 2-no effect | 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. | 24 hours | 
| Effect of pruritus treatment | The effect of pruritus treatment will be observed. Evaluation: 0-no medication administered, 1-administered, 2-no effect | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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proximal femur fracture, morphine administration, pain relief, intrathecal administration, parenteral administration, surgery