Renal Tumor
Conditions
Brief summary
The multimodal analgesia for postoperative pain aims for optimal analgesia through additive or synergic drug effects. The multimodal analgesia results in the use of smaller doses of opioids and lowering opioid-related side effects. Non-opioid analgesics, non-steroidal anti-inflammatory drugs (NSAIDs), propacetamol (prodrug of acetaminophen), nefopam are often given along with opioids as part of multimodal analgesia after major surgery. NSAIDS, commonly used non-opioid analgesics, have gastro-intestinal, renal, and cardiac side effects. In contrast, propacetamol or nefopam, two drugs with central analgesic effects, can be safely used as analgesic adjuvants with opioid after nephrectomy, because these drugs do not alter renal function or cause hemorrhagic complications. Recent study demonstrated that the antinociceptive properties of paracetamol (intravenous acetaminophen) associated with the analgesic effectiveness of nefopam could explain the observed synergy of the combination. The aim of this randomized, double-blinded study is to compare the opioid-sparing effect and analgesic efficacy, as well as quality of recovery, of nefopam-propacetamol combination and propacetamol in patients undergoing laparoscopic nephrectomy.
Interventions
DRUGnefopam-propacetamol combination
Patients in both groups will receive intravenous patient-controlled analgesia (PCA) using fentanyl. In nefopam-propacetamol combination group, patients will receive nefopam(20mg mixed to normal saline 100mL) and propacetamol(2g mixed to normal saline 100mL), 30 minutes before the end of operation, every 6 hours for up to 48 hours.
DRUGpropacetamol alone
In propacetamol alone group, patients will receive placebo (normal saline 2 ml mixed to normal saline 100mL) and propacetamol(2g mixed to normal saline 100mL), 30 minutes before the end of operation, every 6 hours for up to 48 hours.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* ASA status 1-3, * aged 20 to 65 years, * undergoing laparoscopic nephrectomy
Exclusion criteria
* Severe cardiac disease, * hepatic insufficiency, * chronic kidney disease stage ≥3, * preoperative use of analgesics(corticosteroids, opioid), * chronic alcoholics, * hemolytic anemia, * convulsions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Recovery | at 24 hours postoperative | Quality of recovery questionnaire score at 24 hours after surgery |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative opioid consumption | at 24 and at 48 hours after surgery |
Countries
South Korea
Outcome results
None listed