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A randomized double-blind controlled trial comparing 0.2 mg, 0.1 mg, or without intrathecal morphine combined with periarticular injection in unilateral total knee arthropla

Side-effect profiles and efficacy of low dose intrathecal morphine combine with periarticular injection in elective primary unilateral total knee arthroplasty

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20180825003
Enrollment
Unknown
Registered
2018-08-25
Start date
2018-04-27
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

Post operative pain control in total knee arthroplasty Side effect profiles of intrathecal morphine Efficacy of intrathecal morphine Efficacy of local infiltration analgesia side effect morphine intrathecal morphine spinal morphine local infiltration analgesia total knee arthroplasty PONV

Interventions

periarticular injection + 0.2 mg intrathecal morphine,periarticular injection + 0.1 mg intrathecal morphine,periarticular injection alone
M2,M1,M0

Sponsors

Navamindradhiraj University research found
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 85 Years

Inclusion criteria

Inclusion criteria: - Age 45-85 years old - ASA physical status I-III - Scheduled for elective primary unilateral TKA

Exclusion criteria

Exclusion criteria: - Contraindication to neuraxial anesthesia - Allergy to any of the ingredients of the periarticular injection solution - Allergy to acetaminophen or any medications use in research study - Revision and/or bilateral TKA - Chronic pain unrelated to their knee joint - Chronic opioid use (3 months or longer) - Preexisting neuropathy involving operative site - Inflammatory joint disease - Major psychological problems - History of coronary artery bypass graft surgery - History of gastrointestinal ulcer or bleeding - Pregnancy or breastfeeding - Impaired renal function(Glomerular Filtration Rate (GFR) < 30 mL/min)

Design outcomes

Primary

MeasureTime frame
side-effect profiles of 0.1 mg and 0.2 mg intrathecal morphine combine with periarticular injection post operative at 0,4,8,12,16,24,48,72 hr nausea/vomiting score,pruritic score, Ramsey sedation score

Secondary

MeasureTime frame
The incidence of side-effect profile of intrathecal morphine in the first 24 h post operative at 0,4,8,12,16,24,48,72 hr nausea/vomiting score,pruritic score, Ramsey sedation score,The efficacy of intrathecal morphine in the first 24 hours. post operative at 0,4,8,12,16,24 hr pain score

Countries

thailand

Contacts

Public ContactChompunoot Pathonsamit

Anesthesiologist

chompunoot@nmu.ac.th022443266

Outcome results

None listed

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