Caudal Analgesia & Anticoagulated Patient

Anticoagulants and Bleeding Disorders Clinical Trial

Official title:

Caudal Analgesia in Anticoagulated Chronic Pain Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05946850
• Other study ID #: Salem2018 Caudal Blk Anticoag
• Status: Recruiting
• Start date: January 2, 2008
• Est. completion date: December 31, 2024

Study information

• Verified date: July 2023
• Source: Salem Anaesthesia Pain Clinic
• Contact: Olu Bamgbade, MD,FRCPC
• Phone: 17786286600
• Email: salem.painclinic[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 99 Years

Eligibility

Inclusion Criteria:

• adult chronic pain patients who undergo caudal analgesia

Exclusion Criteria:

• chronic pain patients who refuse caudal analgesia

Related Conditions & MeSH terms

• Anticoagulants and Bleeding Disorders
• Blood Coagulation Disorders
• Hemostatic Disorders

Intervention

Procedure:
• Caudal analgesia
Caudal analgesia for chronic lumbosacral pain

Locations

Country	Name	City	State
Canada	Salem Anaesthesia Pain Clinic	Surrey	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Salem Anaesthesia Pain Clinic

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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