Caudal Analgesia & Anticoagulated Patient | NCT05946850

Studies
Caudal Analgesia & Anticoagulated Patient

NCT05946850

Sponsor

Salem Anaesthesia Pain Clinic

Status

Recruiting

Last Update Posted

Jan 27, 2025Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Lumbar Pain Syndrome
Anticoagulants and Bleeding Disorders

Interventions

Caudal analgesia

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

Recruiting

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, 2025Estimated

Completion Date

Dec 31, 2025Estimated

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

Caudal analgesia is an effective intervention for lumbosacral pain. Some chronic pain patients take anticoagulants for vasculopathy treatment. Anticoagulation limits the use of caudal analgesia because of the risk of epidural bleeding. Caudal analgesia may be safe and effective in anticoagulated chronic pain patients.

Quantitative analysis of prospective clinical data. Evaluation of caudal analgesia efficacy and safety in anticoagulated chronic pain patients. Analysis of outcome, and complications.

Detailed Description

Caudal analgesia is an effective interventional therapy for chronic lumbosacral pain. Some chronic pain patients take anticoagulants for vasculopathy treatment. Anticoagulation limits the use of caudal analgesia because of the risk of epidural bleeding. Anticoagulation may be discontinued briefly, to allow caudal injection. Interruption of anticoagulation may be difficult and dangerous for some high-risk patients. Caudal analgesia may be safe and effective in anticoagulated chronic pain patients.

Quantitative analysis of prospective clinical data. An evaluation of caudal analgesia safety in anticoagulated chronic pain patients. An analysis of treatment outcome, 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

100Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Caudal analgesia	Procedure	Caudal analgesia for chronic lumbosacral pain

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	12 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

adult chronic pain patients who undergo caudal analgesia

Exclusion Criteria:

chronic pain patients who refuse caudal analgesia

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Adult chronic pain clinic patients who have lumbosacral pain, and undergo caudal analgesia

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Olu Bamgbade, MD,FRCPC	Contact	17786286600		salem.painclinic@gmail.com
Olumuyiwa Bamgbade, MD,FRCPC	Contact	7786286600		olu.bamgbade@gmail.com

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	Recruiting	Surrey	British Columbia	V3S 7J1	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19644537	Background	Manchikanti L, Boswell MV, Singh V, Benyamin RM, Fellows B, Abdi S, Buenaventura RM, Conn A, Datta S, Derby R, Falco FJ, Erhart S, Diwan S, Hayek SM, Helm S, Parr AT, Schultz DM, Smith HS, Wolfer LR, Hirsch JA; ASIPP-IPM. Comprehensive evidence-based guidelines for interventional techniques in the management of chronic spinal pain. Pain Physician. 2009 Jul-Aug;12(4):699-802.

ID	Term
D013001	Somatoform Disorders
D020141	Hemostatic Disorders

ID	Term
D001523	Mental Disorders
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D006474	Hemorrhagic Disorders