Postoperative Pain Relieve for Patients Undergoing Surgical Treatment of Femoral Fracture
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intrathecal morphine administration Study subjects randomized into this arm will be administered morphine intrathecally in the dose of dose 100 ug. |
Drug: Intrathecal morphine administration
Administration of morphine into the spinal canal.
|
| Active Comparator: Parenteral administration of analgesics Study subjects randomized into this arm will receive standard postoperative pain management (parenteral administration of analgesics). |
Drug: Parenteral administration of analgesics
Standard postoperative pain management of analgesics using parenteral route of administration.
|
Outcome Measures
Primary Outcome Measures
- 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
- Hypoventilation - bradypnea [24 hours]
The observed parameters of hypoventilation include bradypnea = respiratory rate (RR)<10/min
- Hypoventilation - hypopnea [24 hours]
The observed parameters of hypoventilation will include hypopnea = TV < 4 ml/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 - hypoxemia [24 hours]
The observed parameters of hypoventilation will include hypoxemia according to the analysis of blood gasses
- 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
- 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
- Effect of antiemetics [24 hours]
The effect of antiemetics will be observed. Evaluation: 0-not administered, 1-administered, 2-no effect
- 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.
- Effect of pruritus treatment [24 hours]
The effect of pruritus treatment will be observed. Evaluation: 0-no medication administered, 1-administered, 2-no effect
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospital Ostrava | Ostrava | Moravian-Silesian Region | Czechia | 70852 |
Sponsors and Collaborators
- University Hospital Ostrava
Investigators
- Principal Investigator: Denis Buršík, MD, University Hospital Ostrava
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- FNO-KARIM2021-1
- 2021-002765-17