A Comparison of Nefopam-propacetamol Combination and Propacetamol for Postoperative Quality of Recovery After Laparoscopic Nephrectomy

Study Overview
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Brief Summary
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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.

Conditions
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Renal Tumor

Intervention / Treatment
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* Drug: nefopam-propacetamol combination
* Drug: propacetamol alone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nefopam-propacetamol combination group<br> | Drug: nefopam-propacetamol combination<br>* 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.<br>|
| Active Comparator: propacetamol alone group<br> | Drug: propacetamol alone<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Recovery | Quality of recovery questionnaire score at 24 hours after surgery | at 24 hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative opioid consumption |  | at 24 and at 48 hours after surgery |