Comparison of Efficacy of Intra-articular Morphine vs Methylprednisolone in Patients With Knee Osteoarthritis.

NCT06163755 | Withdrawn Phase 2

• 1 other identifier: 11549
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Prospective randomized double-blind controlled study. Participating patients with knee pain secondary to knee osteoarthritis will be randomized to either the DepoMedrol 40mg + 0.25% Bupivacaine (total Volume 5 ml) vs Morphine 3mg group+0.5% Bupivacaine (total volume 5ml) for their intra-articular knee injection. Before the injections, baseline values of NRS (Numerical rating scale) and WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) Questionnaire will be recorded by investigator. After the injections NRS and WOMAC will be recorded at 30mins and on discharge. Patient will be contacted by phone to assess the effectivity of block or any side effects on day 1, 7,30 and 45, information including NRS (at rest and household activity), WOMAC, supplemental analgesic, Side effects (pruritus, paresthesia, urinary retention, nausea, vomiting, dizziness, rash) will be obtained from the patient at the above time intervals. follow up visit will be scheduled 60days after the procedure for re-evaluation.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• WOMAC score

  Primary end point is the change from the baseline NRS score after 30mins after injection

  30mins after procedure

Secondary Outcomes (1)

• NRS score

  30mins after procedure

Study Arms (2)

Group- 1, Morphine Group

EXPERIMENTAL

Morphine 3mg group+0.5% Bupivacaine (total volume 5ml) for Intra-articular knee injection.

Drug: Methylprednisolone 40 MG Injection

Group- 2 , DepoMedrol ( Methylprednisone) Group

ACTIVE COMPARATOR

(control Group - Standard of care ) - DepoMedrol 40mg + 0.25% Bupivacaine (total Volume 5 ml) for Intra-articular knee injection.

Drug: Methylprednisolone 40 MG Injection

Interventions

Methylprednisolone 40 MG Injection DRUG

Intra-articular knee injection will be performed in patient with knee osteoarthritis who meets inclusion criteria. After Random assignment Patient will either get Intra-articular Morphine with Bupivacaine or Depomedrol with Bupivacaine.

Also known as: Methylprednisolone

Group- 1, Morphine Group; Group- 2 , DepoMedrol ( Methylprednisone) Group

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years, patients undergoing intra-articular knee injection for unilateral or bilateral chronic knee pain due to knee osteoarthritis with symptoms (pain, functional limitation due to knee pain and restricted knee range of motion) for a period of at least 3 months in patient who already tried conservative management ( Physical therapy and medication management including NSAIDS if there is no contraindication).

You may not qualify if:

• We will exclude patients with severe cardiopulmonary or brain disease; active infection; a history of anaphylactic reaction to contrast medium, anesthetic, opioids or steroids; pregnancy; malignant disease, patients who had under gone knee or hip surgery and patients who had been using opioids during the 24 hours prior to the study, patient refusal, uncontrolled diabetes with complications- BS \> 300 and patient with ongoing anticoagulation therapy. Patient with osteoarthritis involving joints other than knee causing pain and functional limitation will also be excluded from study

Sponsors & Collaborators

• Henry Ford Health System: lead

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Methylprednisolone; Injections

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedic Surgeon

Study Record Dates

• First Submitted: December 4, 2017
• First Posted: December 11, 2023
• Study Start: January 1, 2018
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: December 11, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share