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)
Overview
- Phase
- Phase 4
- Intervention
- Intrathecal morphine administration
- Conditions
- Proximal Femur Fracture
- Sponsor
- University Hospital Ostrava
- Enrollment
- 82
- Locations
- 1
- Primary Endpoint
- Pain assessment
- Status
- Completed
- Last Updated
- 5 months ago
Overview
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.
Investigators
Eligibility 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
Arms & Interventions
Intrathecal morphine administration
Study subjects randomized into this arm will be administered morphine intrathecally in the dose of dose 100 ug.
Intervention: Intrathecal morphine administration
Parenteral administration of analgesics
Study subjects randomized into this arm will receive standard postoperative pain management (parenteral administration of analgesics).
Intervention: Parenteral administration of analgesics
Outcomes
Primary Outcomes
Pain assessment
Time Frame: 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
Time Frame: 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
Time Frame: 24 hours
The time to administration of rescue medication (analgesics) will be observed in hours.
Total consumption of opioids on Intensive Care Unit
Time Frame: 24 hours
The total consumption of opioids on Intensive Care Unit will be measured in the number of administered doses.
Secondary Outcomes
- Hypotension(24 hours)
- Bradycardia(24 hours)
- Postoperative nausea and vomiting(24 hours)
- Pruritus(24 hours)
- Hypoventilation - bradypnea(24 hours)
- Hypoventilation - presence of hypopnea (TV < 4)(24 hours)
- Hypoventilation - SpO2(24 hours)
- Hypoventilation - presence of hypoxemia (paO2) (below 10 kPa)(24 hours)
- Hypoventilation - other signs of respiratory insufficiency(24 hours)
- Effect of antiemetics(24 hours)
- Effect of pruritus treatment(24 hours)