Intra-Articular Dexmedetomidine: A Treatment for Chronic Knee Pain

NCT06641206 | Recruiting

• 1 other identifier: 36264PR843/9/24
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic knee osteoarthritis (KOA) is a painful condition with limited treatment options. Non-pharmacological approaches often fall short, leading to decreased quality of life. Ozone therapy, a simple and affordable treatment, has shown promise for pain relief. Dexmedetomidine (DEX), a sedative and analgesic, has been used successfully as an adjuvant to anesthesia and local anesthetics. Given its potential for pain management, exploring DEX as a treatment for KOA could offer a new and promising approach.

Conditions

Chronic Knee Pain

Outcome Measures

Primary Outcomes (1)

• Proportion of patients reporting at least a 50% reduction in pain (measured by Numerical Rating Scale) post-intra-articular Injection.

  Value of intra-articular Injection in Pain Reduction of chronic knee pain manifested by recurrence of pain.

  7 months

Study Arms (2)

Group 1

ACTIVE COMPARATOR

A group of Patients from Tanta University suffering from Chronic painful knee osteoarthritis who didn't receive medical treatment and progressed to have chronic pain with decreased physical function and poorer quality of life.

Drug: Triamcinolone Acetonide; Drug: Bupivacaine Hydrochloride

Group 2

ACTIVE COMPARATOR

A group of Patients from Tanta University suffering from Chronic painful knee osteoarthritis who didn't receive medical treatment and progressed to have chronic pain with decreased physical function and poorer quality of life.

Drug: Dexmedetomidine

Interventions

Triamcinolone Acetonide DRUG

1 ml of triamcinolone acetonide was used to prepare a solution for knee injection for patients with Chronic Knee Pain

Group 1

Bupivacaine Hydrochloride DRUG

20mg of bupivacaine hydrochloride was used to prepare a solution for knee injection for patients with Chronic Knee Pain

Group 1

Dexmedetomidine DRUG

Dexmedetomidine solution was prepared by mixing Dexmedetomidine in a dose of 3 µg/kg in 5-ml saline

Group 2

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients were not assigned for surgical intervention;

You may not qualify if:

• Patients were assigned for surgical intervention;
• Patients who had uncontrolled hypertension and/or diabetes mellitus;
• Patients who had uncompensated cardiac, renal, or hepatic diseases;
• Patients with coagulopathy, spinal deformity, allergy, or contraindication for the used drugs;
• Patients who refused to sign the informed consent were excluded from the study.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El Gharbyia, 13511, Egypt

RECRUITING

MeSH Terms

Interventions

Triamcinolone Acetonide; Bupivacaine; Dexmedetomidine

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of Anesthesia and Surgical ICU, Faculty of Medicine

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: October 15, 2024
• Study Start: September 17, 2024
• Primary Completion: January 1, 2025
• Study Completion: March 1, 2025
• Last Updated: October 15, 2024

Record last verified: 2024-10

Locations

EG (1)