Postoperative Analgesia
Conditions
Keywords
Paracetamol and Mannitol Injection, postoperative analgesia, thoracic surgery
Brief summary
This study thoroughly evaluates the efficacy of acetaminophen mannitol injection for postoperative analgesia in patients undergoing thoracoscopic lobectomy, by comparing it with a control group.
Interventions
DRUGParacetamol and Mannitol Injection
Paracetamol and Mannitol Injection 500mg
DRUGParecoxib
40mg of parecoxib
Sponsors
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Obtain informed consent； 2. Patients scheduled for partial lobectomy under thoracoscopy with general anesthesia； 3. Classified as American Society of Anesthesiologists (ASA) physical status I\ II； 4. Age over 18 years； 5. Patients voluntarily participate and sign the informed consent form
Exclusion criteria
1. Systolic blood pressure ≥180 mm Hg or \<90 mm Hg, diastolic blood pressure ≥110 mm Hg or \<60 mmHg 2. heart rate \<50 beats/min； 3. Patients with severe liver or kidney dysfunction (severe liver dysfunction: ALT, conjugated bilirubin, AST, ALP, total bilirubin any one \>2 times the upper limit of normal 4. severe kidney dysfunction: creatinine clearance \<60 ml/min)； 5. Patients with diabetes and complications (diabetic ketoacidosis, hyperosmolar coma, various infections, major vascular changes, diabetic nephropathy, retinopathy, diabetic cardiomyopathy, diabetic neuropathy, diabetic foot, etc.)； 6. Patients with severe pulmonary impairment, such as asthma or chronic obstructive pulmonary disease； 7. History of psychiatric illness or long-term use of psychiatric drugs, chronic pain medication, or history of alcohol abuse； 8. Neuromuscular diseases； 9. Tendency towards malignant hyperthermia； 10. Allergy to the study drug or other contraindications； 11. Participation in another drug clinical trial within the past 30 days； 12. Any cerebrovascular accidents such as stroke, transient ischemic attack (TIA) in the last 3 months； 13. Unstable angina, myocardial infarction in the last 3 months； 14. Undergone another surgery within the last 3 months； 15. Coagulopathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NRS scores | after extubation 10 (±5) minutes, before leaving the resuscitation room, 6 hours, 12 hours, 24 hours after surgery | NRS scores at rest and during movement (coughing) after extubation 10 (±5) minutes, before leaving the resuscitation room, 6 hours, 12 hours, 24 hours after surgery |
| RASS score | after extubation 10 (±5) minutes and 24 hours after surgery | RASS score after extubation 10 (±5) minutes and 24 hours after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative liver enzyme level | Time 1 (Within 5 minutes of the surgery), Time 2 (1 day post-surgery), Time 3 (2 days post-surgery) | Measurement of level of liver enzymes in the blood in Time 1 (Within 5 minutes of the surgery), Time 2 (1 day post-surgery), Time 3 (2 days post-surgery) |
| Postoperative bilirubin level | Time 1 (Within 5 minutes of the surgery), Time 2 (1 day post-surgery), Time 3 (2 days post-surgery) | Measurement of level of bilirubin in the blood in Time 1 (Within 5 minutes of the surgery), Time 2 (1 day post-surgery), Time 3 (2 days post-surgery) |
| Postoperative creatinine level | Time 1 (Within 5 minutes of the surgery), Time 2 (1 day post-surgery), Time 3 (2 days post-surgery) | Measurement of level of creatinine in the blood in Time 1 (Within 5 minutes of the surgery), Time 2 (1 day post-surgery), Time 3 (2 days post-surgery) |
| Time of first use of remedial analgesics or analgesic pump | From the end of surgery until the date of first use of remedial analgesics or analgesic pumps,assessed up to 3 days | Time of first use of remedial analgesics or analgesic pump after surgery,assessed up to 3 days |
| Postoperative IL-6 level | Time 1 (Within 5 minutes of the surgery), Time 2 (1 day post-surgery), Time 3 (2 days post-surgery) | Measurement of level of IL-6 in the blood in Time 1 (Within 5 minutes of the surgery), Time 2 (1 day post-surgery), Time 3 (2 days post-surgery) |
| Postoperative IL-8 level | Time 1 (Within 5 minutes of the surgery), Time 2 (1 day post-surgery), Time 3 (2 days post-surgery) | Measurement of level of IL-8 in the blood in Time 1 (Within 5 minutes of the surgery), Time 2 (1 day post-surgery), Time 3 (2 days post-surgery) |
| Postoperative cortisol level | Time 1 (Within 5 minutes of the surgery), Time 2 (1 day post-surgery), Time 3 (2 days post-surgery) | Measurement of level of ccortisol in the blood in Time 1 (Within 5 minutes of the surgery), Time 2 (1 day post-surgery), Time 3 (2 days post-surgery) |
| Total analgesic pump drug use | From the end of surgery until removal of the analgesic pump,assessed up to 3 days | The total drug use of analgesic pump was recorded during follow-up |
Contacts
Primary ContactJianHong Xu
Outcome results
None listed