The analgesic efficacy of intravenous lidocaine infusion after laparoscopic fundoplication: a prospective, randomized, double-blind, placebo-controlled trial

Gregory J Dale, Stephanie Phillips, Gregory L Falk, Gregory J Dale, Stephanie Phillips, Gregory L Falk

Abstract

This study aimed to determine if intravenous lidocaine infusion reduces postoperative pain intensity following laparoscopic fundoplication surgery and to also validate the safety of intravenous lidocaine at the dose tested. This was an equally randomized, double-blind, placebo-controlled, parallel-group, single center trial. Adult patients undergoing laparoscopic fundoplication were recruited. The intervention group received 1 mg/kg intravenous lidocaine bolus prior to induction of anesthesia, then an intravenous infusion at 2 mg/kg/h for 24 hours. The primary outcome was pain, measured using a numeric rating scale for 30 hours postoperatively. Secondary outcomes were nausea and vomiting, opioid requirements, adverse events, serum lidocaine concentration, and length of hospital stay. The study was terminated after an interim analysis of 24 patients showed evidence of futility. There was no difference in postoperative pain scores (lidocaine versus control, mean ± standard deviation) at rest (2.0 ± 2.7 vs 2.1 ± 2.4, P=0.286) or with movement (2.0 ± 2.6 vs 2.6 ± 2.7, P=0.487). Three adverse events occurred in the lidocaine group (25% of patients). Intravenous lidocaine did not provide clinically significant analgesia to patients undergoing laparoscopic fundoplication. The serum lidocaine concentration of patients who experienced adverse events were within the therapeutic range. This trial cannot confirm the safety of intravenous lidocaine at the dose tested.

Keywords: analgesia; intravenous infusions; local anesthetics; pharmacokinetics.

Conflict of interest statement

GJD received research scholarships from the University of Sydney for his involvement in the project. The authors report no other conflicts of interest in this work.

Figures

Figure 1
Figure 1
The CONSORT methods diagram showing participant flow. Abbreviation: CONSORT, consolidated standards of reporting trials.
Figure 2
Figure 2
Box and whisker plot of pain scores at rest for lidocaine (blue) and control groups (green) at 6-hour intervals for 30 hours following laparoscopic fundoplication. Notes: ○, outlier; ⋆, extreme outlier. Pain was assessed using an 11-point numeric rating scale (NRS-11). No significant difference between groups.
Figure 3
Figure 3
Box and whisker plot of pain scores with movement for lidocaine (blue) and control groups (green) at 6-hour intervals for 30 hours following laparoscopic fundoplication. Notes: ○, outlier; ⋆, extreme outlier. Pain was assessed using an 11-point numeric rating scale (NRS-11). No significant difference between groups.
Figure 4
Figure 4
Serum concentration-time profile of lidocaine for each of the 12 patients receiving an intravenous lidocaine infusion (1 mg/kg loading dose, then 2 mg/kg/h for 24 hours). Note: Different colored lines represent each of the 12 patients.

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