NCT05946863

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2008

Completed
15.5 years until next milestone

First Submitted

Initial submission to the registry

July 7, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 14, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

January 27, 2025

Status Verified

January 1, 2025

Enrollment Period

16 years

First QC Date

July 7, 2023

Last Update Submit

January 23, 2025

Conditions

Hip FracturesAnticoagulants and Bleeding Disorders

Keywords

Caudal anesthesia

Outcome Measures

Primary Outcomes (1)

  • 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

    1 month

Eligibility Criteria

Age50 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult or elderly patients with fractured hip or femoral neck who undergo emergency surgical repair

You may qualify if:

  • Patients with fractured hip or femoral neck who undergo surgical repair

You may not qualify if:

  • Patients who refuse surgical repair

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Salem Anaesthesia Pain Clinic

Surrey, British Columbia, V3S 7J1, Canada

Location

Related Publications (1)

  • 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.

    PMID: 18289230BACKGROUND

MeSH Terms

Conditions

Hip FracturesHemostatic Disorders

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesVascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Olu Bamgbade, MD,FRCPC

    Salem Anaesthesia Pain Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2023

First Posted

July 14, 2023

Study Start

January 2, 2008

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

January 27, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)