Bilateral Total knee arthroplasty Spinal nalbuphine Nalbuphine Intrathecal
Conditions
Interventions
2.4-3.0 ml (12-15 mg) of 0.5% isobupivacaine +1.5 mg nalbuphine ,2.4-3.0 ml (12-15 mg) of 0.5% isobupivacaine +0.15 ml Normal Saline (NSS)
Experimental Drug,Placebo Comparator No treatment
Intrathecal nalbuphine ,Normal saline
Sponsors
Faculty of Medicine, Siriraj Hospital, Mahidol University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Patient scheduled for elective bilateral total knee arthroplasty under spinal anesthesia 2. American Society of Anesthesiologists(ASA) physical status I-III 3. Age 18-100 years 4. BMI < 40 kg/m2
Exclusion criteria
Exclusion criteria: 1. Patient with contraindication for spinal anesthesia such as patient refusal, infection at the site of injection, increase intracranial pressure or uncorrected hypovolemia. 2. History of allergy or sensitive to drugs used in research: bupivacaine, ketorolac, dexamethasone, paracetamol, tranexamic acid 3. Patient with previous knee surgery 4. Patient with opioid-exposure (defined as any opioid exposure < 60 MED in 90 days prior to DOS) 5. Patient with opioid-tolerance (defined as any opioid exposure >= 60 MED in 7 days prior to DOS) 6. Patient with cognitive impairment who is unable to comprehend or use the verbal rating pain scoring system or patient-controlled analgesia (PCA) pump 7. Patient with chronic kidney disease (CKD) less than eGFR <50 mL/min/1.73m2 8. Patient with Coronary artery disease 9. Patient with cerebrovascular disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy of intrathecal nalbuphine 24 hours postoperatively morphine consumption | — |
Secondary
| Measure | Time frame |
|---|---|
| morphine consumption at 48 and 72 hours postoperatively morphine consumption ,pain intensity at rest and on movement at 0, 4, 8, 12, 24, 48, 72 hours NRS,time to first ambulation - hours,incidence of adverse effects at 72 hours nausea and vomiting, pruritus, respiratory depression and hypotension,satisfaction of patient at 72 hours satisfaction score 1-10 | — |
Countries
Thailand
Contacts
Public ContactPeerachatra Mangmeesri
Faculty of Medicine, Siriraj Hospital
Outcome results
None listed