Pain relief after surgery for proximal femur fractures
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)
PHASE4 · University Hospital Ostrava · NCT05920642
This study is testing whether giving morphine directly into the spine can help people who have had surgery for hip fractures feel less pain compared to regular pain medications.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 60 Years to 90 Years |
| Sex | All |
| Sponsor | University Hospital Ostrava (other) |
| Locations | 1 site (Ostrava, Moravian-Silesian Region) |
| Trial ID | NCT05920642 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of intrathecal morphine administration compared to standard parenteral analgesics for postoperative pain relief in patients undergoing surgical treatment for proximal femoral fractures. It is a monocentric, randomized, and single-blinded study involving 50 patients. The primary focus is on pain management, while secondary outcomes include monitoring the frequency of adverse effects associated with intrathecal morphine. The study aims to provide insights into optimizing pain relief strategies in this patient population.
Who should consider this trial
Good fit: Ideal candidates are patients aged 60 to 90 years who are undergoing surgical treatment for proximal femur fractures and are classified as ASA I to III.
Not a fit: Patients who undergo surgery under general anesthesia or have allergies to opioids may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for patients recovering from proximal femur fracture surgery.
How similar studies have performed: Previous studies have shown promising results with intrathecal morphine for pain relief, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Ostrava, Moravian-Silesian Region
- University Hospital Ostrava — Ostrava, Moravian-Silesian Region, Czechia (RECRUITING)
Study contacts
- Principal investigator: Denis Buršík, MD — University Hospital Ostrava
- Study coordinator: Jiří Hynčica
- Email: jiri.hyncica@fno.cz
- Phone: 0042059737
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Proximal Femur Fracture, proximal femur fracture, morphine administration, pain relief, intrathecal administration, parenteral administration, surgery