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CompletedNCT07037745Updated Jun 25, 2025

Dexamethasone + Intrathecal Morphine in Hip Fractures

An observational study in Hip Fracture Surgeries, sponsored by Kanuni Sultan Suleyman Training and Research Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-06-25.

Sponsored by Kanuni Sultan Suleyman Training and Research Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
80
Ages
65 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Hip Fracture Surgeries

Keywords

  • postoperative pain
  • hip fracture
  • geriatric
  • spinal morphine
  • multimodale analgesia
03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's enrollment of 80 is below the median of 102 across 608 observational studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Kanuni Sultan Suleyman Training and Research Hospital is the lead sponsor of 216 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Geriatric (age 65 and over) patients with hip fractures

Inclusion criteria

  • Age 65 and above,
  • both genders,
  • performing hip fracture surgery under spinal anesthesia using 0.1 mg intrathecal morphine

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
80 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: First 24 hours postoperatively

07

Study locations

1 site
  • Istanbul Kanuni Sultan Süleyman Training and Research Hospital
    Istanbul, 34303, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: Undecided — No decision has been made yet. Of course, the study data will be shared if permission is received from the responsible researcher.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07037745
Lead sponsor
Kanuni Sultan Suleyman Training and Research Hospital
Responsible party
Kadir Arslan (Specialist physician, Kanuni Sultan Suleyman Training and Research Hospital) — Principal investigator
First posted
Jun 25, 2025
Start date
Oct 1, 2024
Primary completion
Jun 15, 2025
Completion
Jun 15, 2025
Last update
Jun 25, 2025

Study contacts

Kadir Arslan, M.D.
principal investigator · University of Health Sciences Turkey, Istanbul Kanuni Sultan Suleyman Training and Research Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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