Caudal Analgesia & Anticoagulated Patient

• Sponsor: Salem Anaesthesia Pain Clinic (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05946850
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 191.9
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lumbar Pain Syndrome; Anticoagulants and Bleeding Disorders	Procedure: Caudal analgesia

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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Caudal Analgesia in Anticoagulated Chronic Pain Patients
• Actual Study Start Date: Jan 2, 2008
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Outcome Measures

Primary Outcome Measures

1. Pain score, objective measurement using the validated Numeric Pain Rating scale [12 weeks]

   Pain score, using the Numeric Pain Rating scale of 0 to 10, low scores indicate less pain, high scores indicate worse pain

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• adult chronic pain patients who undergo caudal analgesia

Exclusion Criteria:

• chronic pain patients who refuse caudal analgesia

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Salem Anaesthesia Pain Clinic	Surrey	British Columbia	Canada	V3S 7J1

Sponsors and Collaborators

• Salem Anaesthesia Pain Clinic

Investigators

• Principal Investigator: Olu Bamgbade, MD,FRCPC, Salem Anaesthesia Pain Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Salem Anaesthesia Pain Clinic
• ClinicalTrials.gov Identifier: NCT05946850
• Other Study ID Numbers: Salem2018 Caudal Blk Anticoag
• First Posted: Jul 14, 2023
• Last Update Posted: Jul 17, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Salem Anaesthesia Pain Clinic: Caudal analgesia
• Additional relevant MeSH terms: Hemostatic Disorders; Blood Coagulation Disorders

Study Results

No Results Posted as of Jul 17, 2023