Philippe Cuvillon1,2, Lana Zoric3,4, Christophe Demattei5, Sandrine Alonso5, Françoise Casano3,4, Joel L'hermite3,4, Jacques Ripart3,4, Jean-Yves Lefrant3,4, Laurent Muller3,4. 1. Department of Anesthesiology and Pain Management, Caremeau University Hospital, Nîmes, France - philippe.cuvillon@chu-nimes.fr. 2. Montpellier 1 University, Montpellier, France - philippe.cuvillon@chu-nimes.fr. 3. Department of Anesthesiology and Pain Management, Caremeau University Hospital, Nîmes, France. 4. Montpellier 1 University, Montpellier, France. 5. Department of Biostatistics, Epidemiology, Public Health, and Medical Information (BESPIM), Nîmes University Hospital, Nîmes, France.
Abstract
BACKGROUND: Because nefopam's morphine-sparing is debated when combined with paracetamol, this study aimed to assess pain relief by IV nefopam in combination with paracetamolafter major abdominal surgery. METHODS: This was a prospective, double-blinded randomized controlled study including patients (ASA I-III, >18 years) scheduled forelective colectomy surgery by laparotomy. Patients were randomized into the nefopam group (N.=37, continuous IV 120 mg nefopam) or control group (N.=32, placebo, same infusion) for 48 hours after surgery (both groups: IV paracetamol 1 g/6 h + IV PCA morphine rescue). The primary endpoint was the total morphine consumption from the potential titration in the postoperative care unit to 48 hours (20% reduction in nefopam group). The secondary endpoints were adverse events and clinical outcomes. RESULTS: Both groups were similar for demographic characteristic, surgery, and anesthesia (including IV sufentanil 20 [20-25] µg for nefopam vs. 22.5 [20-25] µg for the control, P=0.6). Time in PACU and hospital stay were not statistically different. The number of patients requiring titration in PACU and the amount of IV morphine titration were similar. As the main endpoint, morphine consumption over the study period was similar between nefopam and the control group (respectively, 53±37 and 54±34 mg, P=0.86). No difference was observed for pain relief satisfaction between groups or total adverse events like PONV, ileus, desaturation, or confusion (nefopam 14±38 vs. control group 11±34, P=0.77). CONCLUSIONS: This prospective randomized study suggested that nefopam in combination with paracetamol has no benefit after open abdominal surgery.
RCT Entities:
BACKGROUND: Because nefopam's morphine-sparing is debated when combined with paracetamol, this study aimed to assess pain relief by IV nefopam in combination with paracetamol after major abdominal surgery. METHODS: This was a prospective, double-blinded randomized controlled study including patients (ASA I-III, >18 years) scheduled for elective colectomy surgery by laparotomy. Patients were randomized into the nefopam group (N.=37, continuous IV 120 mg nefopam) or control group (N.=32, placebo, same infusion) for 48 hours after surgery (both groups: IV paracetamol 1 g/6 h + IV PCA morphine rescue). The primary endpoint was the total morphine consumption from the potential titration in the postoperative care unit to 48 hours (20% reduction in nefopam group). The secondary endpoints were adverse events and clinical outcomes. RESULTS: Both groups were similar for demographic characteristic, surgery, and anesthesia (including IV sufentanil 20 [20-25] µg for nefopam vs. 22.5 [20-25] µg for the control, P=0.6). Time in PACU and hospital stay were not statistically different. The number of patients requiring titration in PACU and the amount of IV morphine titration were similar. As the main endpoint, morphine consumption over the study period was similar between nefopam and the control group (respectively, 53±37 and 54±34 mg, P=0.86). No difference was observed for pain relief satisfaction between groups or total adverse events like PONV, ileus, desaturation, or confusion (nefopam 14±38 vs. control group 11±34, P=0.77). CONCLUSIONS: This prospective randomized study suggested that nefopam in combination with paracetamol has no benefit after open abdominal surgery.