Hip Fracture SurgeriesNCT07037745
Dexamethasone + Intrathecal Morphine in Hip Fractures
An observational study of Hip Fracture Surgeries, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Hip fractures (proximal femur fractures) are a global public health problem with high morbidity and mortality rates, especially in the geriatric population aged 65 years and older. Hip fractures, an important consequence of osteoporosis, occur as a result of low-energy trauma with advancing age. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fracture Surgeries
- Type of treatment
- Injection or infusion
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2024to 15 Jun 2025
- Phase
- Observational
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Geriatric (age 65 and over) patients with hip fractures
Who may be able to join
- Age 65 and above,
- both genders,
- performing hip fracture surgery under spinal anesthesia using 0.1 mg intrathecal morphine
Who cannot join
- Performing another operation with a hip fracture,
- Conversion to general anesthesia after spinal anesthesia,
- Peroperative severe cardiovascular and respiratory failure,
- Systemic steroid use,
- Uncontrolled diabetes,
- Lack of cooperation that makes it difficult to assess the level of pain and -nausea/vomiting in the postoperative period, cognitive impairment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Kanuni Sultan Süleyman Training and Research Hospital
Istanbul, 34303
About this study
Official title: The Effect of Intravenous Dexamethasone in Addition to Intrathecal Morphine on Postoperative Analgesia and Nausea/Vomiting in Geriatric Hip Fractures: A Retrospective Study
Hip fractures (proximal femur fractures) are a global public health problem with high morbidity and mortality rates, especially in the geriatric population aged 65 years and older. Hip fractures, an important consequence of osteoporosis, occur as a result of low-energy trauma with advancing age. Increased mortality rates are associated with an increased risk of postoperative complications, the need for an intensive care unit, prolonged hospital stay, and decreased quality of life.
Multimodal analgesia strategies in geriatric hip fracture patients aim to provide adequate pain control while limiting systemic opioid use. Spinal anesthesia, one of the neuraxial anesthesia methods, is frequently used in this patient group, as it avoids complications associated with general anesthesia. It has been reported that the addition of intrathecal morphine (ITM) to local anesthetics used in minimal-dose spinal anesthesia is practical in postoperative pain control. It has been reported that the use of ITM in the dose range of 0.1-0.2 mg in major orthopedic surgeries such as total hip arthroplasty significantly reduces systemic opioid use and provides a decrease in early pain scores. Nausea, vomiting, and decreased gastrointestinal function in the postoperative period may impair patient comfort. In addition, depending on the dose used, ITM may cause side effects such as postoperative nausea and vomiting (PONV) and pruritus. It has been reported that perioperative use of intravenous dexamethasone reduces postoperative pain scores and the consumed analgesic dose in patients undergoing spinal anesthesia using ITM, as well as reducing PONV. Although the benefit of opioid-sparing analgesia provided by ITM in geriatric hip fracture patients is important, the role of intravenous dexamethasone in effectively controlling side effects such as nausea, vomiting, and pruritus, which may increase with it, is a current and critical area of research.
This study aimed to investigate the effect of intravenous (8 mg) dexamethasone added to intrathecal morphine (0.1 mg) on postoperative pain scores, opioid consumption, PONV, and pruritus in geriatric hip fracture patients.
Read the detailed description
The study is a retrospective cohort study conducted in a tertiary center. In our clinic, hip fracture operations are frequently performed under spinal anesthesia using ITM in geriatric hip fracture patients. In this study, the effects of intravenous 8 mg dexamethasone on analgesia scores, PONV, and pruritus adverse effects in geriatric hip fracture patients under spinal anesthesia using 0.1 mg ITM will be investigated.
Pain scores, PONV, and pruritus parameters of hip fracture patients who were and were not administered intravenous 8 mg dexamethasone after spinal anesthesia using ITM will be analyzed.
- Conditions
- Hip Fracture Surgeries
- Keywords
- postoperative pain, hip fracture, geriatric, spinal morphine, multimodale analgesia
- Medical subject headings
- Pain, Postoperative, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group D | Group that received 0.1 mg intrathecal morphine and 8 mg intravenous dexamethasone | |
| Group C | 0.1 mg intrathecal morphine and 8 mg intravenous dexamethasone were not administered in the group, control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Assessment
The Visual Analog Scale (VAS) will be used to determine the intensity of pain and to compare the pain felt before and after treatment (2, 6, 12, and 24 hours postoperatively.). VAS is a reliable and easily applicable test used to measure values that cannot be easily measured numerically by converting them into a numerical format. The lowest and highest definitions of the parameters to be evaluated are written on both ends of a 100 mm line. The patient is asked to mark the most appropriate value (location) between these two extreme points. When this scale is used for pain, the numbers "0" are written on one end to indicate no pain, and "10" are written on the other end to indicate the most severe pain, and this is converted into a template, numbers between 0-10 are placed on the line, and the patient is asked to choose the closest number.
Measured: 2, 6, 12, and 24 hours postoperatively
Secondary outcomes (1)
Paracetamol, diclofenac sodium and tramadol consumption
In the postoperative period, if geriatric hip fracture patients followed in the ward or intensive care unit experience pain, paracetamol 1 g (Rastamol 10mg/mL vial, Haver Farma, Turkey) is administered intravenously three times. In patients who complain of pain despite taking paracetamol, diclofenac sodium (Dichloron 75 mg/3 mL, Deva Farma, Turkey) is administered intramuscularly at a dose of 75 mg, 1 to 3 times. If there is no pain relief with diclofenac, tramadol hydrochloride (Tradolex 100 mg/2mL, Menta Farma, Turkey) can be infused in 100 mL of saline.
Measured: First 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start1 Oct 2024
- Primary completion15 Jun 2025
- Study completion15 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip Fracture SurgeriesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kadir Arslan, Kanuni Sultan Suleyman Training and Research Hospital
- Investigators
- Kadir Arslan, M.D., Principal investigator, University of Health Sciences Turkey, Istanbul Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07037745
- Sponsor's protocol ID
- KAEK/2024.09.185
- Status last verified
- Sep 2024
- First submitted
- 15 Jun 2025
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: No decision has been made yet. Of course, the study data will be shared if permission is received from the responsible researcher.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intravenous Dexamethasone in Addition to Intrathecal Morphine on Postoperative Analgesia and Nausea/Vomiting in Geriatric Hip Fractures: A Retrospective Study
- ClinicalTrials.gov ID
- NCT07037745
- Acronym / sponsor ID
- KAEK/2024.09.185
- Conditions
- Hip Fracture Surgeries
- Keywords
- postoperative pain, hip fracture, geriatric, spinal morphine, multimodale analgesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 15 Jun 2025 (actual)
- First posted
- 25 Jun 2025 (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.
Hip fractures (proximal femur fractures) are a global public health problem with high morbidity and mortality rates, especially in the geriatric population aged 65 years and older. Hip fractures, an important consequence of osteoporosis, occur as a result of low-energy trauma with advancing age. Increased mortality rates are associated with an increased risk of postoperative complications, the need for an intensive care unit, prolonged hospital stay, and decreased quality of life.
Multimodal analgesia strategies in geriatric hip fracture patients aim to provide adequate pain control while limiting systemic opioid use. Spinal anesthesia, one of the neuraxial anesthesia methods, is frequently used in this patient group, as it avoids complications associated with general anesthesia. It has been reported that the addition of intrathecal morphine (ITM) to local anesthetics used in minimal-dose spinal anesthesia is practical in postoperative pain control. It has been reported that the use of ITM in the dose range of 0.1-0.2 mg in major orthopedic surgeries such as total hip arthroplasty significantly reduces systemic opioid use and provides a decrease in early pain scores. Nausea, vomiting, and decreased gastrointestinal function in the postoperative period may impair patient comfort. In addition, depending on the dose used, ITM may cause side effects such as postoperative nausea and vomiting (PONV) and pruritus. It has been reported that perioperative use of intravenous dexamethasone reduces postoperative pain scores and the consumed analgesic dose in patients undergoing spinal anesthesia using ITM, as well as reducing PONV. Although the benefit of opioid-sparing analgesia provided by ITM in geriatric hip fracture patients is important, the role of intravenous dexamethasone in effectively controlling side effects such as nausea, vomiting, and pruritus, which may increase with it, is a current and critical area of research.
This study aimed to investigate the effect of intravenous (8 mg) dexamethasone added to intrathecal morphine (0.1 mg) on postoperative pain scores, opioid consumption, PONV, and pruritus in geriatric hip fracture patients.
Detailed description
The study is a retrospective cohort study conducted in a tertiary center. In our clinic, hip fracture operations are frequently performed under spinal anesthesia using ITM in geriatric hip fracture patients. In this study, the effects of intravenous 8 mg dexamethasone on analgesia scores, PONV, and pruritus adverse effects in geriatric hip fracture patients under spinal anesthesia using 0.1 mg ITM will be investigated.
Pain scores, PONV, and pruritus parameters of hip fracture patients who were and were not administered intravenous 8 mg dexamethasone after spinal anesthesia using ITM will be analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group D | – | –Group that received 0.1 mg intrathecal morphine and 8 mg intravenous dexamethasone |
| Group C | – | –0.1 mg intrathecal morphine and 8 mg intravenous dexamethasone were not administered in the group, control group |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Geriatric (age 65 and over) patients with hip fractures
Key inclusion criteria (3 listed)
- Age 65 and above,
- both genders,
- performing hip fracture surgery under spinal anesthesia using 0.1 mg intrathecal morphine
Key exclusion criteria (6 listed)
- Performing another operation with a hip fracture,
- Conversion to general anesthesia after spinal anesthesia,
- Peroperative severe cardiovascular and respiratory failure,
- Systemic steroid use,
- Uncontrolled diabetes,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain Assessment
Time frame: 2, 6, 12, and 24 hours postoperatively
The Visual Analog Scale (VAS) will be used to determine the intensity of pain and to compare the pain felt before and after treatment (2, 6, 12, and 24 hours postoperatively.). VAS is a reliable and easily applicable test used to measure values that cannot be easily measured numerically by converting them into a numerical format. The lowest and highest definitions of the parameters to be evaluated are written on both ends of a 100 mm line. The patient is asked to mark the most appropriate value (location) between these two extreme points. When this scale is used for pain, the numbers "0" are written on one end to indicate no pain, and "10" are written on the other end to indicate the most severe pain, and this is converted into a template, numbers between 0-10 are placed on the line, and the patient is asked to choose the closest number.
1 secondary outcome
Paracetamol, diclofenac sodium and tramadol consumption
Time frame: First 24 hours postoperatively
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 Jun 2025.
- Individual participant dataSharing planned: Undecided. No decision has been made yet. Of course, the study data will be shared if permission is received from the responsible researcher.
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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.
Kadir Arslan, M.D. principal investigator
University of Health Sciences Turkey, Istanbul Kanuni Sultan Suleyman Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Fracture Surgeries, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 6 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 Jun 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 Turkey (Türkiye). 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.
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: 2, 6, 12, and 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jun 2025; AzTrials last refreshed its copy on 31 Oct 2026.