Increasing dose of esketamine for supplemental analgesia after complex spinal fusion surgery: a randomized and double-blind trial
Abstract
Background: Complex spinal surgery is associated with significant trauma and pain. Herein we tested the hypothesis that increasing the dose of esketamine, as a supplement to patient-controlled analgesia, might improve pain relief after extensive spinal surgery.
Methods: In this randomized, double-blind, and controlled trial, we enrolled adults who were scheduled to undergo extensive posterior spinal fusion. Participants were randomized in a 1:1:1 ratio to receive patient-controlled sufentanil-dexmedetomidine analgesia supplemented with esketamine at 0.25 (Esk25), 0.5 (Esk50), or 0.75 (Esk75) mg/ml. Our primary endpoint was an integrated index of pain intensity and opioid consumption (ranging from - 200% to + 200%, with higher scores indicating greater pain and/or more opioid consumption) with movement within 72 h after surgery.
Results: A total of 312 patients (median 38 years; 24.4% female) were enrolled and randomized; all were included in the intention-to-treat analysis. The primary endpoint did not differ among three groups (Esk50 vs. Esk25: mean difference - 2 [95% CI -31 to 28]; Esk75 vs. Esk25: mean difference 13 [95% CI -16 to 43]. The proportions reporting nausea/vomiting and nausea were higher in the Esk75 group than in the Esk25 group (nausea/vomiting: 70.2% [73/104] with Esk75 vs. 52.9% [55/104] with Esk25; P = 0.021; nausea: 68.3% [71/104] with Esk75 vs. 49.0% [51/104] with Esk25; P = 0.005).
Conclusions: For adult patients recovering from extensive posterior…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 312 participants or records.
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