Postoperative Pain Relieve for Patients Undergoing Surgical Treatment of Femoral Fracture
- Conditions
- Proximal Femur Fracture
- Interventions
- Drug: Parenteral administration of analgesics
- Registration Number
- NCT05920642
- Lead Sponsor
- University Hospital Ostrava
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 75
- 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
- general anesthesia used for the operation
- allergy to opioids
- high risk of respiratory depression
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intrathecal morphine administration Intrathecal morphine administration Study subjects randomized into this arm will be administered morphine intrathecally in the dose of dose 100 ug. Parenteral administration of analgesics Parenteral administration of analgesics Study subjects randomized into this arm will receive standard postoperative pain management (parenteral administration of analgesics).
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Postoperative nausea and vomiting 24 hours The incidence of postoperative and vomiting will be observed. Evaluation: 0-no, 1-nausea, 2-vomiting
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.
Hypoventilation - bradypnea 24 hours The observed parameters of hypoventilation include bradypnea = respiratory rate (RR)\<10/min
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).
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
Effect of antiemetics 24 hours The effect of antiemetics will be observed. Evaluation: 0-not administered, 1-administered, 2-no effect
Effect of pruritus treatment 24 hours The effect of pruritus treatment will be observed. Evaluation: 0-no medication administered, 1-administered, 2-no effect
Trial Locations
- Locations (1)
University Hospital Ostrava
🇨🇿Ostrava, Moravian-Silesian Region, Czechia