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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-002765-17 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intrathecal morphine administration | Experimental | Study subjects randomized into this arm will be administered morphine intrathecally in the dose of dose 100 ug. |
|
| Parenteral administration of analgesics | Active Comparator | Study subjects randomized into this arm will receive standard postoperative pain management (parenteral administration of analgesics). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intrathecal morphine administration | Drug | Administration of morphine into the spinal canal. |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Denis BurÅ¡Ãk, MD | University Hospital Ostrava | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Ostrava | Ostrava | Moravian-Silesian Region | 70852 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14570664 | Background | Rathmell JP, Pino CA, Taylor R, Patrin T, Viani BA. Intrathecal morphine for postoperative analgesia: a randomized, controlled, dose-ranging study after hip and knee arthroplasty. Anesth Analg. 2003 Nov;97(5):1452-1457. doi: 10.1213/01.ANE.0000083374.44039.9E. | |
| 19921358 | Background | Yamashita K, Fukusaki M, Ando Y, Tanabe T, Terao Y, Sumikawa K. Postoperative analgesia with minidose intrathecal morphine for bipolar hip prosthesis in extremely elderly patients. J Anesth. 2009;23(4):504-7. doi: 10.1007/s00540-009-0817-5. Epub 2009 Nov 18. |
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There is no plan to make the individual participant data public.
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| ID | Term |
|---|---|
| D000092526 | Proximal Femoral Fractures |
| ID | Term |
|---|---|
| D005265 | Femoral Neck Fractures |
| D006620 | Hip Fractures |
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
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The study subjects will be randomized into two parallel groups.
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The participant will not know which arm of the study he/she has been enrolled into.
| Parenteral administration of analgesics | Drug | Standard postoperative pain management of analgesics using parenteral route of administration. |
|
| 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 |
| 11847368 | Background | Kwan AS, Lee BB, Brake T. Intrathecal morphine for post-operative analgesia in patients with fractured hips. Hong Kong Med J. 1997 Sep;3(3):250-255. |
| D014947 |
| Wounds and Injuries |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |