Postoperative Pain Relieve for Patients Undergoing Surgical Treatment of Femoral Fracture

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)

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.

Study Overview

• Status: Completed
• Conditions: Proximal Femur Fracture
• Intervention / Treatment: Drug: Intrathecal morphine administration; Drug: Parenteral administration of analgesics

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 Type: Interventional
• Enrollment (Actual): 82
• Phase: Phase 4

Contacts and Locations

Study Locations

• Czechia
  • Moravian-Silesian Region
    • Ostrava, Moravian-Silesian Region, Czechia, 70852
      • University Hospital Ostrava

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypoventilation - bradypnea	The observed parameters of hypoventilation include bradypnea = respiratory rate (RR)<10/min	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
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
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

Collaborators and Investigators

• Sponsor: University Hospital Ostrava
• Investigators: Principal Investigator: Denis Buršík, MD, University Hospital Ostrava

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2023
• Primary Completion (Actual): July 29, 2025
• Study Completion (Actual): July 29, 2025

Study Registration Dates

• First Submitted: June 7, 2023
• First Submitted That Met QC Criteria: June 16, 2023
• First Posted (Actual): June 27, 2023

Study Record Updates

• Last Update Posted (Actual): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: surgery; pain relief; proximal femur fracture; morphine administration; intrathecal administration; parenteral administration
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Femoral Fractures; Hip Injuries; Hip Fractures; Femoral Neck Fractures; Proximal Femoral Fractures; Physiological Effects of Drugs; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine; Analgesics
• Other Study ID Numbers: FNO-KARIM2021-1; 2021-002765-17 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to make the individual participant data public.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No