Acute postoperative pain after major spine surgery Major spine surgery, Acute postoperative pain, Dinalbuphine sebacate
Conditions
Interventions
Dinalbuphine sebacate 150 mg/2ml Intramuscular injection at posterior thigh (Z-track technique) 12- 24 hours before operation,Normal saline 2ml Intramuscular injection at posterior thigh (Z-track tec
Experimental Drug,Placebo Comparator Drug
Extended-release dinalbuphine sebacate(ERDS),Placebo
Sponsors
Faculty of Medicine Siriraj Hospital
DKSH Thailand
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients who undergo Elective open thoracolumbar spine surgery : 3 or more levels or 1 level with instrumentation 2. Age 18-70 years 3. ASA physical status I-III 4. The extubation is expected postoperatively 5. Can rate the numerical rating pain scale and can use intravenous patient-controlled analgesia(IV-PCA) postoperatively
Exclusion criteria
Exclusion criteria: 1. Previous spine surgery 2. BMI less than 18 or more than 35 kg/m2 3. Pregnancy or lactation 4. History of drug allergy or has contraindication to Nalbuphine, Sesame oil, Benzyl benzoate, Morphine, and other drugs used in this study eg. Paracetamol, NSAIDs 5. Chronic kidney disease GFR less than 60 ml/min (calculated by CKD-EPI equation) 6. Chronic liver disease or abnormal liver function test 7. Use of CYP 3A4 inducers eg. Phenytoin, Phenobarbital, Carbamazepine, Rifampin or CYP 3A4 inhibitors eg. Clarithromycin, Protease inhibitor, Ketoconazole, Voriconazole 8. Special precaution to the use of Dinalbuphine sebacate - Head injury or Increase Intracranial pressure - Abnormal respiratory function eg. OSA, COPD, Asthma - History of CNS depressants usage and need to continue postoperatively - Adrenal insufficiency - Severe hypotension - Gastrointestinal conditions eg. ileus, gastrointestinal obstruction - Seizure disorder - Substance addiction,abuse,misuse 9. Chronic opioid use 10. Uncontrolled Diabetes mellitus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total morphine consumption 48 hours postoperative Milligram of Morphine that patient recived from IV-PCA (intravenous patient control analgesia) | — |
Secondary
| Measure | Time frame |
|---|---|
| Area under the curve of Numerical rating scale 48 hours postoperative and 7 days postoperative Numerical rating scale,Time to first rescue analgesia postoperative period Hour,Intraoperative opioid consumption intraoperative period Milligram of morphine and morphine equivalent,Postoperative opioid consumption 7 days postoperative Milligram of morphine and morphine equivalent,Opioid side effect : Nausea/Vomiting, Pruritus, Respiratory depression, Fever, Injection site reaction 7 days postoperative Patient reported outcome using a questionnaire interview,Length of hospital stay Postoperative period Days,Patient satisfaction Postoperative period Scale from 1 to 10 | — |
Countries
Thailand
Contacts
Public ContactSuppachai Poolsuppasit
Siriraj hospital
Outcome results
None listed