BACKGROUND:Perioperative ketamine infusion reduces postoperative pain; perioperative lidocaine infusion reduces postoperative narcotic consumption, speeds recovery of intestinal function, improves postoperative fatigue, and shortens hospital stay. However, it is unknown whether perioperative IV lidocaine and/or ketamine enhances acute functional recovery. We therefore tested the primary hypothesis that perioperative IV lidocaine and/or ketamine in patients undergoing open abdominal hysterectomy improves rehabilitation as measured by a 6-minute walk distance (6-MWD) on the second postoperative morning. METHODS:Women having open hysterectomy were anesthetized with sevoflurane, followed by patient-controlled morphine. Patients were factorially randomized to one of the following groups: (1) lidocaine and placebo, (2) placebo and ketamine, (3) placebo and placebo, or (4) lidocaine and ketamine. Lidocaine was given as a bolus (1.5 mg/kg), followed by lidocaine infusion of 2 mg/kg/h for the first 2 hours, and then 1.2 mg/kg/h for 24 postoperative hours. Ketamine was given as a bolus (0.35 mg/kg), followed by ketamine infusion of 0.2 mg/kg/h for the first 2 hours, and then 0.12 mg/kg/h for 24 postoperative hours. The primary double-blind outcome was 6-MWD on the second postoperative morning; secondary outcomes included pain scores, opioid consumption, postoperative nausea and vomiting, and fatigue score. RESULTS: The study was stopped after a planned interim analysis of 64 patients showed that lidocaine crossed the preplanned futility boundary, with mean ± SD of 202 ± 66 m versus 202 ± 73 m for lidocaine versus placebo, respectively, and mean difference (interim adjusted 97.5% confidence interval) of 0.93 m (-52, 54) (P = 0.96); the ketamine effect also crossed the futility boundary, with mean ± SD of 193 ± 77 m versus 210 ± 61 m for ketamine versus placebo, respectively, and mean difference (interim adjusted 97.5% confidence interval) of -11 m (-65, 44) (P = 0.54). No interaction between the 2 intervention effects was observed (P = 0.96). Neither intervention significantly influenced any of the secondary outcomes. CONCLUSION: Our results do not support use of lidocaine or ketamine for improving 6-MWD on the second postoperative day after open hysterectomy.
RCT Entities:
BACKGROUND: Perioperative ketamine infusion reduces postoperative pain; perioperative lidocaine infusion reduces postoperative narcotic consumption, speeds recovery of intestinal function, improves postoperative fatigue, and shortens hospital stay. However, it is unknown whether perioperative IV lidocaine and/or ketamine enhances acute functional recovery. We therefore tested the primary hypothesis that perioperative IV lidocaine and/or ketamine in patients undergoing open abdominal hysterectomy improves rehabilitation as measured by a 6-minute walk distance (6-MWD) on the second postoperative morning. METHODS:Women having open hysterectomy were anesthetized with sevoflurane, followed by patient-controlled morphine. Patients were factorially randomized to one of the following groups: (1) lidocaine and placebo, (2) placebo and ketamine, (3) placebo and placebo, or (4) lidocaine and ketamine. Lidocaine was given as a bolus (1.5 mg/kg), followed by lidocaine infusion of 2 mg/kg/h for the first 2 hours, and then 1.2 mg/kg/h for 24 postoperative hours. Ketamine was given as a bolus (0.35 mg/kg), followed by ketamine infusion of 0.2 mg/kg/h for the first 2 hours, and then 0.12 mg/kg/h for 24 postoperative hours. The primary double-blind outcome was 6-MWD on the second postoperative morning; secondary outcomes included pain scores, opioid consumption, postoperative nausea and vomiting, and fatigue score. RESULTS: The study was stopped after a planned interim analysis of 64 patients showed that lidocaine crossed the preplanned futility boundary, with mean ± SD of 202 ± 66 m versus 202 ± 73 m for lidocaine versus placebo, respectively, and mean difference (interim adjusted 97.5% confidence interval) of 0.93 m (-52, 54) (P = 0.96); the ketamine effect also crossed the futility boundary, with mean ± SD of 193 ± 77 m versus 210 ± 61 m for ketamine versus placebo, respectively, and mean difference (interim adjusted 97.5% confidence interval) of -11 m (-65, 44) (P = 0.54). No interaction between the 2 intervention effects was observed (P = 0.96). Neither intervention significantly influenced any of the secondary outcomes. CONCLUSION: Our results do not support use of lidocaine or ketamine for improving 6-MWD on the second postoperative day after open hysterectomy.
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