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A Randomized, Double-Blind, Placebo-Controlled Study to Compare the Efficacy of Combination of Lidocaine with Nalbuphine or Triamcinolone versus Lidocaine Alone for Pain Management in intraarticular injection of osteoarthritic knee.

A Randomized, Double-Blind, Placebo-Controlled Study to Compare the Efficacy of Combination of Lidocaine with Nalbuphine or Triamcinolone versus Lidocaine Alone for Pain Management in intraarticular injection of osteoarthritic knee.

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20211028004
Enrollment
132
Registered
2021-10-28
Start date
2021-10-13
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

osteoarthritic knee patients Nalbuphine, triamcinolone, pain intensity, side effects

Interventions

normal saline with 40mg. lidocaine,nalbuphine with 40 mg. lidocaine,nalbuphine with 40 mg. lidocaine,Triamcinolone with 40 mg. lidocaine
control ,Nalbuphine 5 mg,Nalbuphine 10 mg.,Triamcinolone 40 mg.

Sponsors

None listed

Eligibility

Sex/Gender
All
Age
50 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients that have been diagnosed with osteoarthritis According to the diagnostic guidelines, the criteria for the diagnosis of osteoarthritis of the American College of Rheumatology include Patients with knee pain and bone replacement from radiography (radiographic osteophytes) with at least 1 of the following: morning stiffness less than 30 minutes or there is a cracking noise (crepitus) in the knee while moving 2. Age less than or equal 65 years. 3. Pain intensity by VAS score equal or more than 5/10

Exclusion criteria

Exclusion criteria: 1. Received systemic administration of analgesics within 24 hours before study 2. Received medication about CNS such as anticonvulsant, tramadol, muscle relaxant, anxiolytic, tranquilizers and antipsychotics 3. Suspected septic knee joint 4. Acute or severe bronchial asthma 5. High risk for gastrointestinal obstruction included paralytic ileus 6. History for allergy nalbuphine 7. Adrenal Insufficiency 8. Epilepsy 9. Pregnancy or lactation 10. Severe hypotension 11. Psychotic disorder 12. Suspected cerebrovascular bleeding

Design outcomes

Primary

MeasureTime frame
Pain intensity 0,5,10,15,20,25,30,35,40,45,50,55,60 minutes VAS

Secondary

MeasureTime frame
PROM 1 week, 1 month, 2 months, and 3 months WOMAC,PROM 1 week, 1 month, 2 months, and 3 months ROM,first time that patients need analgesic drug 1 day, 1 week, 1month, 2 months, 3 months time,side effect 0,5,10,15,20,25,30,35,40,45,50,55,60 minutes, 1 day, 1 week, 1 month, 2 months, and 3 months symptoms

Countries

Thailand

Contacts

Public Contactbura sindhupakorn

Suranaree University of Technology Institute of Social Technology

bura@sut.ac.th0805886686

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026