Hip FractureNCT01547468
A Comparison of Two Pain Control Techniques on Deliruim in Hip Fracture Patients
A study testing Femoral Nerve Catheterization and Intravenous Opioids in people with Hip Fracture, run by Leslie Thomas at 1 site in United States.
Trial summary
The purpose of this study is compare the rates of post-operative delirium between a group of people receiving intravenous (IV) pain control after hip fracture surgery and a group of people receiving a femoral nerve catheter for pain control. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hip Fracture
- What is being tested?
- Femoral Nerve Catheterization and Intravenous Opioids
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to 19 Apr 2022
- Phase
- Interventional
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 50 and older
- Presenting to Ochsner Main Campus with a hip fracture
Who cannot join
- Head trauma as reported in the medical record and/or patient response
- High impact fractures as reported in the medical record
- Aphasia as reported in the medical record and/or patient response
- Deafness, blindness as reported in the medical record and/or patient response
- True allergy (not sensitivity or side effects) to local anesthetics or opiates
- Pregnant
- Inability to complete study activities pre-operatively
Trial locations and contacts
1 site in 1 country.
United States1 site
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
About this study
Official title: Does Femoral Nerve Catheterization Reduce the Incidence of Post-Operative Delirium in Patients Presenting for Hip Fracture Repair?
The purpose of this study is compare the rates of post-operative delirium between a group of people receiving intravenous (IV) pain control after hip fracture surgery and a group of people receiving a femoral nerve catheter for pain control. Post-operative delirium is confusion that can happen after the deep sleep of anesthesia. AThe hypothesis is that the group receiving the femoral nerve catheter for pain may have a lower incidence of delirium than the group receiveing IV pain medication.
Read the detailed description
Subjects will have their hearing and vision tested. They will have their ability to think and analyze information tested using 4 questionnaires/ surveys: The Confusion Assesment Method (CAM), the Mini-Mental Status Examination (MMSE), Modified Blessed Dementia scale (MBDS), and Barthel's Activities of Daily Living (ADL). They will have pain medication prior to surgery based on the doctor's orders.
On the day of surgery, subjects will be randomized (like a flip of a coin) into one of two groups. One group will receive IV medication to control for pain after surgery. The other group will receive a femoral nerve catheter to control for pain after surgery.
A femoral nerve catheter is the small tubing that delivers numbing medicine to the nerves around the hips that control pain. This will be placed either before, during or soon after your surgery to help with pain after the surgery. This catheter is placed using an ultrasound machine. Subjects will still have pain medication through the IV before surgery if the catheter is put into their leg.
After surgery, you will be given the pain medication either through the IV or through the catheter in your leg. The catheter will be left in after surgery for 2-3 days delivering numbing medicine to the nerves. If subjects have the catheter in their leg and need more pain medication, the medication will be given to them through the IV.
Subjects will be visited by a member of the study staff on the second and third day after surgery. The study staff member will ask questions about the subject's ability to think and analyze information.
- Conditions
- Hip Fracture
- Being tested
- Femoral Nerve Catheterization, Intravenous Opioids
- Keywords
- hip fracture, elderly, delirium, broken hip, hip, surgery, orthopedic, orthopedic surgery, pain, anesthesia, Ochsner Clinic, Ochsner Hospital, Leslie Thomas MD, New Orleans, Louisiana
- Medical subject headings
- Hip Fractures, Delirium, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femoral Nerve CatheterizationProcedure or surgery
Also called FNC
A femoral nerve catheter will be placed prior to surgery in this group.
Intravenous OpioidsProcedure or surgery
Also called IV opioids
Intravenous opioids will be given after surgery to provide pain relief to subjects assigned to this group.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Opioids | Active comparator | Not described Receives: Procedure: Intravenous Opioids |
| Femoral Nerve Catheterization | Experimental | Not described Receives: Procedure: Femoral Nerve Catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of participants developing delirium post-operatively
Measured: 3 days post-operatively
Secondary outcomes (2)
the number of days admitted to the hospital post-operatively
Measured: participants will be followed for the duration of the hospital stay, an expected average of 4 days
Is there a difference in pain scores between subjects receiving the femoral nerve catheter vs. opioid only therapy for hip fracture pain using the visual analog scale (VAS) and consumption of pain medication for breakthrough pain relief?
Two VAS scores, at least 6 hours apart, will be taken from the medical chart on post-op day 2 and again on post-op day 3. The amount of pain medication (opioids), such as morphine, hydrocodone, oxycodone, etc. consumed will be recorded until discharge.
Measured: post-op day 2 and again on post-op day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study startMar 2012
- Primary completion19 Apr 2022
- Study completion19 Apr 2022
Why it stopped: inactivity and unable to complete due to manpower issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leslie Thomas
- Sponsor type
- University, hospital or other
- Collaborators
- American Society of Anesthesiologists
- Responsible party
- Sponsor-investigator, Leslie Thomas, Ochsner Health System
- Investigators
- Leslie Thomas, MD, Principal investigator, Ochsner Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01547468
- Sponsor's protocol ID
- 2010.198.C
- Status last verified
- Apr 2022
- First submitted
- 27 Feb 2012
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Femoral Nerve Catheterization Reduce the Incidence of Post-Operative Delirium in Patients Presenting for Hip Fracture Repair?
- ClinicalTrials.gov ID
- NCT01547468
- Acronym / sponsor ID
- 2010.198.C
- Conditions
- Hip Fracture
- Keywords
- hip fracture, elderly, delirium, broken hip, hip, surgery, orthopedic, orthopedic surgery
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: inactivity and unable to complete due to manpower issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Leslie ThomasUniversity, hospital or other
- Collaborators
- American Society of Anesthesiologists
- Study start
- Mar 2012
- Primary completion
- 19 Apr 2022 (actual)
- Study completion
- 19 Apr 2022 (actual)
- First posted
- 7 Mar 2012 (estimated)
- 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 purpose of this study is compare the rates of post-operative delirium between a group of people receiving intravenous (IV) pain control after hip fracture surgery and a group of people receiving a femoral nerve catheter for pain control. Post-operative delirium is confusion that can happen after the deep sleep of anesthesia. AThe hypothesis is that the group receiving the femoral nerve catheter for pain may have a lower incidence of delirium than the group receiveing IV pain medication.
Detailed description
Subjects will have their hearing and vision tested. They will have their ability to think and analyze information tested using 4 questionnaires/ surveys: The Confusion Assesment Method (CAM), the Mini-Mental Status Examination (MMSE), Modified Blessed Dementia scale (MBDS), and Barthel's Activities of Daily Living (ADL). They will have pain medication prior to surgery based on the doctor's orders.
On the day of surgery, subjects will be randomized (like a flip of a coin) into one of two groups. One group will receive IV medication to control for pain after surgery. The other group will receive a femoral nerve catheter to control for pain after surgery.
A femoral nerve catheter is the small tubing that delivers numbing medicine to the nerves around the hips that control pain. This will be placed either before, during or soon after your surgery to help with pain after the surgery. This catheter is placed using an ultrasound machine. Subjects will still have pain medication through the IV before surgery if the catheter is put into their leg.
After surgery, you will be given the pain medication either through the IV or through the catheter in your leg. The catheter will be left in after surgery for 2-3 days delivering numbing medicine to the nerves. If subjects have the catheter in their leg and need more pain medication, the medication will be given to them through the IV.
Subjects will be visited by a member of the study staff on the second and third day after surgery. The study staff member will ask questions about the subject's ability to think and analyze information.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous Opioids | Active comparator | Procedure: Intravenous Opioids |
| Femoral Nerve Catheterization | Experimental | Procedure: Femoral Nerve Catheterization |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 50 and older
- Presenting to Ochsner Main Campus with a hip fracture
Key exclusion criteria (7 listed)
- Head trauma as reported in the medical record and/or patient response
- High impact fractures as reported in the medical record
- Aphasia as reported in the medical record and/or patient response
- Deafness, blindness as reported in the medical record and/or patient response
- True allergy (not sensitivity or side effects) to local anesthetics or opiates
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 |
|---|---|---|
| Femoral Nerve CatheterizationAlso: FNCA femoral nerve catheter will be placed prior to surgery in this group. | Procedure or surgery | Femoral Nerve Catheterization |
| Intravenous OpioidsAlso: IV opioidsIntravenous opioids will be given after surgery to provide pain relief to subjects assigned to this group. | Procedure or surgery | Intravenous Opioids |
Primary outcome
number of participants developing delirium post-operatively
Time frame: 3 days post-operatively
2 secondary outcomes
the number of days admitted to the hospital post-operatively
Time frame: participants will be followed for the duration of the hospital stay, an expected average of 4 days
Is there a difference in pain scores between subjects receiving the femoral nerve catheter vs. opioid only therapy for hip fracture pain using the visual analog scale (VAS) and consumption of pain medication for breakthrough pain relief?
Time frame: post-op day 2 and again on post-op day 3
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
Related trials for Hip Fracture
Not yet recruitingPhase 4
Effect of Ondansetron on the Incidence of Spinal Anaesthesia-Induced Hypotension in Elderly Patients Undergoing Fracture Hip Surgery
Spinal Anaesthesia Induced Hypotension
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
Active, not recruiting
Lumbar-Sacral Plexus Block vs Fascia Iliaca Block Plus Low-Dose Spinal Anesthesia for Femoral Neck Fracture Surgery
Femoral Neck Fractures, Nerve Block
RecruitingObservational study
Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures
Fracture; Pelvic, Insufficiency Fractures
Not yet recruiting
A Decision Support Tool for Common Surgical Fixations of Hip Fractures
Hip Fracture Surgeries, High Risk Population of Hip Fractures
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.
Leslie Thomas, MD principal investigator
Ochsner Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Femoral Nerve Catheterization and Intravenous Opioids in people with Hip Fracture, run by Leslie Thomas at 1 site in United States.
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 2 inclusion and 7 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: withdrawn, as of the sponsor's last update on 27 Apr 2022. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
number of participants developing delirium post-operatively (time frame: 3 days post-operatively). 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 27 Apr 2022.