Caudal Block & Hip Fracture Surgery in Anticoagulated Pat... | NCT05946863

Studies
Caudal Block & Hip Fracture Surgery in Anticoagulated Patient

NCT05946863

Sponsor

Salem Anaesthesia Pain Clinic

Status

Completed

Last Update Posted

Jan 27, 2025Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Hip Fractures
Anticoagulants and Bleeding Disorders

Interventions

Not provided

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2, 2008Actual

Primary Completion Date

Dec 31, 2023Actual

Completion Date

Dec 31, 2023Actual

First Submitted Date

Jul 7, 2023

First Submission Date that Met QC Criteria

Jul 7, 2023

First Posted Date

Jul 14, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 23, 2025

Last Update Posted Date

Jan 27, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with fractured hip or femoral neck who undergo surgical repair

Exclusion Criteria:

Patients who refuse surgical repair

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Olu Bamgbade, MD,FRCPC	Salem Anaesthesia Pain Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Salem Anaesthesia Pain Clinic		Surrey	British Columbia	V3S 7J1	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18289230	Background	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.

ID	Term
D006620	Hip Fractures
D020141	Hemostatic Disorders

ID	Term
D005264	Femoral Fractures
D050723	Fractures, Bone
D014947	Wounds and Injuries
D025981	Hip Injuries