Proximal Femur FracturePhase 4NCT05920642
Postoperative Pain Relieve for Patients Undergoing Surgical Treatment of Femoral Fracture
A Phase 4 study testing Intrathecal morphine administration and Parenteral administration of analgesics in people with Proximal Femur Fracture, run by University Hospital Ostrava at 1 site in Czechia.
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. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Proximal Femur Fracture
- What is being tested?
- Intrathecal morphine administration and Parenteral administration of analgesics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteCzechia
- Study dates
- 4 Sep 2023to 29 Jul 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- general anesthesia used for the operation
- allergy to opioids
- high risk of respiratory depression
Trial locations and contacts
1 site in 1 country.
Czechia1 site
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, 70852
About this study
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)
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.
Read the 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.
- Conditions
- Proximal Femur Fracture
- Being tested
- Intrathecal morphine administration, Parenteral administration of analgesics
- Keywords
- proximal femur fracture, morphine administration, pain relief, intrathecal administration, parenteral administration, surgery
- Medical subject headings
- Proximal Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal morphine administrationDrug
Administration of morphine into the spinal canal.
Parenteral administration of analgesicsDrug
Standard postoperative pain management of analgesics using parenteral route of administration.
| Study group | Role | What they receive |
|---|---|---|
| Intrathecal morphine administration | Experimental | Study subjects randomized into this arm will be administered morphine intrathecally in the dose of dose 100 ug. Receives: Drug: Intrathecal morphine administration |
| Parenteral administration of analgesics | Active comparator | Study subjects randomized into this arm will receive standard postoperative pain management (parenteral administration of analgesics). Receives: Drug: Parenteral administration of analgesics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 24 hours
Time to administration of rescue medication
The time to administration of rescue medication (analgesics) will be observed in hours.
Measured: 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.
Measured: 24 hours
Secondary outcomes (11)
Hypoventilation - bradypnea
The observed parameters of hypoventilation include bradypnea = respiratory rate (RR)<10/min
Measured: 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.
Measured: 24 hours
Hypoventilation - SpO2
The observed parameters of hypoventilation will include inability to maintain oxygen saturation (SpO2) above 90 % without the need for oxygenotherapy.
Measured: 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).
Measured: 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
Measured: 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.
Measured: 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.
Measured: 24 hours
Postoperative nausea and vomiting
The incidence of postoperative and vomiting will be observed. Evaluation: 0-no, 1-nausea, 2-vomiting
Measured: 24 hours
Effect of antiemetics
The effect of antiemetics will be observed. Evaluation: 0-not administered, 1-administered, 2-no effect
Measured: 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.
Measured: 24 hours
Effect of pruritus treatment
The effect of pruritus treatment will be observed. Evaluation: 0-no medication administered, 1-administered, 2-no effect
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start4 Sep 2023
- Primary completion29 Jul 2025
- Study completion29 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Proximal Femur FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study subjects will be randomized into two parallel groups.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Denis Buršík, MD, Principal investigator, University Hospital Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05920642
- Sponsor's protocol ID
- FNO-KARIM2021-1
- Other IDs
- 2021-002765-17
- Status last verified
- Nov 2025
- First submitted
- 7 Jun 2023
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make the individual participant data public.
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.
PubMed 14570664Yamashita 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.
PubMed 19921358Kwan 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.
PubMed 11847368
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05920642
- Acronym / sponsor ID
- FNO-KARIM2021-1
- Conditions
- Proximal Femur Fracture
- Keywords
- proximal femur fracture, morphine administration, pain relief, intrathecal administration, parenteral administration, surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Study start
- 4 Sep 2023 (actual)
- Primary completion
- 29 Jul 2025 (actual)
- Study completion
- 29 Jul 2025 (actual)
- First posted
- 27 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study subjects will be randomized into two parallel groups.
| Arm | Type | Receives |
|---|---|---|
| Intrathecal morphine administration | Experimental | Drug: Intrathecal morphine administrationStudy subjects randomized into this arm will be administered morphine intrathecally in the dose of dose 100 ug. |
| Parenteral administration of analgesics | Active comparator | Drug: Parenteral administration of analgesicsStudy subjects randomized into this arm will receive standard postoperative pain management (parenteral administration of analgesics). |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- general anesthesia used for the operation
- allergy to opioids
- high risk of respiratory depression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intrathecal morphine administrationAdministration of morphine into the spinal canal. | Drug | Intrathecal morphine administration |
| Parenteral administration of analgesicsStandard postoperative pain management of analgesics using parenteral route of administration. | Drug | Parenteral administration of analgesics |
Primary outcome
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.
11 secondary outcomes
Hypoventilation - bradypnea
Time frame: 24 hours
Hypoventilation - presence of hypopnea (TV < 4)
Time frame: 24 hours
Hypoventilation - SpO2
Time frame: 24 hours
Hypoventilation - presence of hypoxemia (paO2) (below 10 kPa)
Time frame: 24 hours
Hypoventilation - other signs of respiratory insufficiency
Time frame: 24 hours
Hypotension
Time frame: 24 hours
Bradycardia
Time frame: 24 hours
Postoperative nausea and vomiting
Time frame: 24 hours
Effect of antiemetics
Time frame: 24 hours
Pruritus
Time frame: 24 hours
Effect of pruritus treatment
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Background: PubMed 14570664Rathmell 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.
- Background: PubMed 19921358Yamashita 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.
- Background: PubMed 11847368Kwan 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.
- Individual participant dataSharing planned: No. There is no plan to make the individual participant data public.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denis Buršík, MD principal investigator
University Hospital Ostrava
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intrathecal morphine administration and Parenteral administration of analgesics in people with Proximal Femur Fracture, run by University Hospital Ostrava at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain assessment (time frame: Every 2 hours after the surgery, total of 24 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05920642, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.