Postoperative Pain Relieve for Patients Undergoing Surgical Treatment of Femoral Fracture

Proximal Femur Fracture Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05920642
• Other study ID #: FNO-KARIM2021-1
• Secondary ID: 2021-002765-17
• Status: Recruiting
• Phase: Phase 4
• Start date: September 4, 2023
• Est. completion date: June 2026

Study information

• Verified date: January 2024
• Source: University Hospital Ostrava
• Contact: Jirí Hyncica
• Phone: 0042059737
• Email: jiri.hyncica[@]fno.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2026
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Femoral Fractures
• Fractures, Bone
• Proximal Femur Fracture

Intervention

Drug:
• Intrathecal morphine administration
Administration of morphine into the spinal canal.
• Parenteral administration of analgesics
Standard postoperative pain management of analgesics using parenteral route of administration.

Locations

Country	Name	City	State
Czechia	University Hospital Ostrava	Ostrava	Moravian-Silesian Region

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Ostrava

Country where clinical trial is conducted

Czechia, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Pain assessment during patient positioning	Pain intensity will be assessed using the VAS10 scale (0-10) during the positioning of the patient.	24 hours
Primary	Time to administration of rescue medication	The time to administration of rescue medication (analgesics) will be observed in hours.	24 hours
Primary	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	Hypoventilation - bradypnea	The observed parameters of hypoventilation include bradypnea = respiratory rate (RR)<10/min	24 hours
Secondary	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
Secondary	Hypoventilation - SpO2	The observed parameters of hypoventilation will include inability to maintain oxygen saturation (SpO2) above 90 % without the need for oxygenotherapy.	24 hours
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Postoperative nausea and vomiting	The incidence of postoperative and vomiting will be observed. Evaluation: 0-no, 1-nausea, 2-vomiting	24 hours
Secondary	Effect of antiemetics	The effect of antiemetics will be observed. Evaluation: 0-not administered, 1-administered, 2-no effect	24 hours
Secondary	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
Secondary	Effect of pruritus treatment	The effect of pruritus treatment will be observed. Evaluation: 0-no medication administered, 1-administered, 2-no effect	24 hours