Hip FracturesNCT05946863
Caudal Block & Hip Fracture Surgery in Anticoagulated Patient
An observational study of Hip Fractures and Anticoagulants and Bleeding Disorders, run by Salem Anaesthesia Pain Clinic at 1 site in Canada.
Trial summary
Hip fractures are common in elderly patients, and require surgery. Many elderly patients take anticoagulants for vasculopathy treatment. Anticoagulation precludes the use of neuraxial anesthesia because of the risk of epidural bleeding. Read more about this study
- Who is it for?
- Ages 50 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Hip Fractures, Anticoagulants and Bleeding Disorders
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 2 Jan 2008to 31 Dec 2023
- 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 50 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult or elderly patients with fractured hip or femoral neck who undergo emergency surgical repair
Who may be able to join
- Patients with fractured hip or femoral neck who undergo surgical repair
Who cannot join
- Patients who refuse surgical repair
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Caudal Anesthesia for Surgical Repair of Fractured Hip or Femoral-neck in Anticoagulated Patients
Hip fractures are common in elderly patients, and require surgery. Many elderly patients take anticoagulants for vasculopathy treatment. Anticoagulation precludes the use of neuraxial anesthesia because of the risk of epidural bleeding. Caudal anesthesia may be a safe and effective technique in anticoagulated emergency surgical patients.
Quantitative analysis of prospective clinical data. Evaluation of caudal anesthesia efficacy for hip fracture surgery. Analysis of perioperative outcome, and postoperative course.
Read the detailed description
Hip or femoral neck fractures are common in elderly patients. These fractures require surgical repair. Many elderly patients take regular anticoagulant therapy for vasculopathy. Anticoagulation precludes the use of spinal or epidural anesthesia because of the risk of epidural bleeding. Caudal anesthesia is another form of neuraxial anesthesia that may be safe and effective for hip fracture surgery in anticoagulated elderly patients.
Quantitative analysis of prospective clinical data. It is an evaluation of caudal anesthesia efficacy for hip fracture surgery. This is an analysis of intraoperative analgesia, perioperative outcome, postoperative course, and complications.
- Keywords
- Caudal anesthesia
- Medical subject headings
- Hip Fractures, Hemostatic Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score, objective measurement using the validated Numeric Pain Rating scale
Pain score, using the Numeric Pain Rating scale of 0 to 10, low scores indicate less pain, high scores indicate worse pain
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start2 Jan 2008
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies 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
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Salem Anaesthesia Pain Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olu Bamgbade, MD,FRCPC, Principal investigator, Salem Anaesthesia Pain Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05946863
- Sponsor's protocol ID
- Salem2017 Caudal Blk NOF Surg
- Status last verified
- Jan 2025
- First submitted
- 7 Jul 2023
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sandby-Thomas M, Sullivan G, Hall JE. A national survey into the peri-operative anaesthetic management of patients presenting for surgical correction of a fractured neck of femur. Anaesthesia. 2008 Mar;63(3):250-8. doi: 10.1111/j.1365-2044.2007.05328.x.
PubMed 18289230
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caudal Anesthesia for Surgical Repair of Fractured Hip or Femoral-neck in Anticoagulated Patients
- ClinicalTrials.gov ID
- NCT05946863
- Acronym / sponsor ID
- Salem2017 Caudal Blk NOF Surg
- Keywords
- Caudal anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Salem Anaesthesia Pain ClinicUniversity, hospital or other
- Study start
- 2 Jan 2008 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 14 Jul 2023 (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 are common in elderly patients, and require surgery. Many elderly patients take anticoagulants for vasculopathy treatment. Anticoagulation precludes the use of neuraxial anesthesia because of the risk of epidural bleeding. Caudal anesthesia may be a safe and effective technique in anticoagulated emergency surgical patients.
Quantitative analysis of prospective clinical data. Evaluation of caudal anesthesia efficacy for hip fracture surgery. Analysis of perioperative outcome, and postoperative course.
Detailed description
Hip or femoral neck fractures are common in elderly patients. These fractures require surgical repair. Many elderly patients take regular anticoagulant therapy for vasculopathy. Anticoagulation precludes the use of spinal or epidural anesthesia because of the risk of epidural bleeding. Caudal anesthesia is another form of neuraxial anesthesia that may be safe and effective for hip fracture surgery in anticoagulated elderly patients.
Quantitative analysis of prospective clinical data. It is an evaluation of caudal anesthesia efficacy for hip fracture surgery. This is an analysis of intraoperative analgesia, perioperative outcome, postoperative course, and complications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult or elderly patients with fractured hip or femoral neck who undergo emergency surgical repair
Key inclusion criteria (1 listed)
- Patients with fractured hip or femoral neck who undergo surgical repair
Key exclusion criteria (1 listed)
- Patients who refuse surgical repair
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 score, objective measurement using the validated Numeric Pain Rating scale
Time frame: 1 month
Pain score, using the Numeric Pain Rating scale of 0 to 10, low scores indicate less pain, high scores indicate worse pain
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 27 Jan 2025.
- Background: PubMed 18289230Sandby-Thomas M, Sullivan G, Hall JE. A national survey into the peri-operative anaesthetic management of patients presenting for surgical correction of a fractured neck of femur. Anaesthesia. 2008 Mar;63(3):250-8. doi: 10.1111/j.1365-2044.2007.05328.x.
- Individual participant dataSharing planned: No
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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.
Olu Bamgbade, MD,FRCPC principal investigator
Salem Anaesthesia Pain Clinic
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 Fractures and Anticoagulants and Bleeding Disorders, run by Salem Anaesthesia Pain Clinic at 1 site in Canada.
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 1 inclusion and 1 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 27 Jan 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 Canada. 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 score, objective measurement using the validated Numeric Pain Rating scale (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05946863, which also lists 1 linked publication.
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 Jan 2025.