Ongoing Clinical Trials for Femoral Neck Fracture
There are currently 2 clinical trials exploring different approaches to pain management in patients undergoing surgery for femoral neck fractures, also known as hip fractures or proximal femur fractures. These trials are investigating the use of intrathecal morphine and methadone to improve pain relief and recovery outcomes for patients with this condition.
Clinical trial locations
- Czechia
- Denmark
Study on Intrathecal Morphine for Pain Relief in Patients with Hip Fractures Undergoing Surgery
This trial, conducted in Czechia, is investigating whether morphine administered directly into the space around the spinal cord provides better pain relief for patients undergoing surgery for hip fractures compared to standard pain management methods.
Who can participate:
- Adults aged 18 to 64 years, both male and female
- Patients with a break in the upper part of the thigh bone near the hip (proximal femur fracture)
- Those classified as ASA I-III, meaning they are either healthy or have mild to moderate health conditions that are not immediately life-threatening
- Patients suitable for a type of anesthesia called subarachnoid block, where medicine is injected near the spinal cord to numb the lower body
- Those who sign an informed consent form agreeing to participate
Who cannot participate:
- Patients outside the 18-64 year age range
- Vulnerable individuals who may not be able to give proper informed consent
- Those who do not meet the general health criteria for the study
What the trial involves:
Participants will be randomly assigned to receive either morphine injected around the spinal cord or standard pain treatment during their surgery. The research team will carefully monitor pain levels at rest and during movement every 2 hours for 24 hours after surgery using a scale from 0 (no pain) to 10 (worst imaginable pain). They will also track how long it takes before patients need additional pain medication and the total amount of pain relief medication used.
The study will also watch for potential side effects including slow breathing, low blood pressure, slow heart rate, nausea, vomiting, and itching, and will evaluate how well treatments for these side effects work.
Investigational drug: Morphine, administered intrathecally (into the space around the spinal cord), is the pain relief medication being tested in this trial.
Study on Methadone and Placebo for Pain Relief in Elderly Patients with Hip Fractures
This trial, taking place in Denmark as part of the larger MetaHip research effort, is examining whether a single dose of methadone given during surgery can improve pain management and recovery for elderly patients with hip fractures. The study is expected to continue until April 2025.
Who can participate:
- Patients aged 60 years or older, both male and female
- Those with an acute hip fracture diagnosed less than 24 hours ago and confirmed by x-rays in the emergency department
- Patients with specific types of hip fractures including:
- Collum femoris fractures (a break in the neck of the thigh bone)
- Pertrochanteric fractures (a break in the upper part of the thigh bone near the hip joint)
- Subtrochanteric fractures (a break just below a small bump on the upper part of the thigh bone)
Who cannot participate:
- Patients not undergoing surgery for their hip fracture
- Those outside the specified age range
- Vulnerable individuals who may have difficulty providing informed consent or are at higher risk of harm
- Patients who do not meet other specific health criteria established for safety and accuracy
What the trial involves:
Before surgery, participants will receive either a single dose of methadone or a placebo (an inactive substance with no medication) delivered directly into a vein. The placebo is used for comparison to determine whether methadone truly provides benefits. After surgery, the research team will monitor several important factors including daily consumption of pain medications (particularly opioids), pain levels, ability to stand and move around, occurrence of nausea or vomiting, time until discharge from the hospital, need for an antidote medication, development of delirium, and constipation.
Regular follow-up appointments will be conducted to evaluate recovery progress and identify any side effects experienced by participants.
Investigational drug: Methadone, a potent pain reliever typically used for severe pain and opioid addiction treatment, is being tested to see if a single dose during surgery can provide better pain relief for elderly hip fracture patients.
Summary
Both ongoing trials focus on improving pain management for patients with femoral neck fractures undergoing surgery, but they target different age groups and use different approaches. The Czech trial investigates intrathecal morphine in adults aged 18-64, while the Danish trial studies methadone in elderly patients aged 60 and older. Each trial explores a different method of delivering pain relief: one through injection around the spinal cord and the other through intravenous administration before surgery.
These studies reflect the medical community’s ongoing efforts to find more effective pain management strategies for hip fracture patients, who often experience severe pain and face challenging recovery periods. The trials are geographically distributed across Central and Northern Europe, providing valuable data from different healthcare settings and patient populations.
