CompletedPhase 4ACTRN12616000478415

Efficacy of 48-hour intravenous (IV) lidocaine infusions in open colorectal surgery.

Intravenous (IV) lidocaine infusions for 48 hours in open colorectal surgery: a prospective, randomised, double-blinded, placebo-controlled trial.


Sponsor

St Vincent's Hospital Sydney Department of Anaesthesia

Enrollment

56 participants

Start Date

Mar 4, 2014

Study Type

Interventional

Conditions

Summary

Background Although i.v. lidocaine is used as a perioperative analgesic in abdominal surgery, evidence of efficacy in terms of surgical recovery, pain scores, and opioid use is limited. The infusion dose and duration remain unclear. This study aimed to investigate the effect of a longer low-dose 48-hour infusion regimen on these outcomes. Methods Fifty-eight adult patients undergoing elective open colorectal surgery were randomised into the lidocaine group (1.5 mg kg-1 followed by 1 mg kg-1 h-1 infusion for 48 hours) and control group (administered equal volumes of normal saline). After surgery, patients were given a patient-controlled analgesia (PCA) machine and time to first bowel movement (primary outcome) and flatus were recorded. Postoperative pain scores (numeric rating scale) and fentanyl PCA consumption were assessed for 72 post-operative hours. Results There was no significant difference in time to first bowel movement [80.1 (42.2) vs 82.5 (40.4) hours; (P=0.83)], time to first flatus [64.7 (38.5) vs 70.0 (31.2) hours; P=0.57], length of hospital stay [9 (8–13) vs 11 (9–14) days; P=0.53], nor post-operative pain scores in the lidocaine vs control arms. Cumulative opioid consumption was significantly lower in the lidocaine vs the control group from 24 hours onwards. At 72 hours, cumulative opioid consumption (mcg fentanyl) in the lidocaine group [1570 (825-3587)] was over 40% lower than in the placebo group [2730 (1778-5327); P=0.039]. Conclusion A 48-hour low-dose i.v. lidocaine infusion reduces postoperative opioid consumption. This is not associated with faster return of bowel function, hospital discharge, or lower pain scores.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 80 Yearss

Inclusion Criteria1

  • Patients aged 18-80 undergoing elective open colorectal surgery

Exclusion Criteria1

  • ASA classification status IV or above; liver cirrhosis; severe chronic renal impairment (serum creatinine > 200 umol L-1); pregnancy; cardiac conduction abnormalities; congestive heart failure; epilepsy; allergy to any of the study medications; opioid or alcohol abuse; and reported bowel movement frequencies greater than 3 per day, or less than 3 per week.

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Interventions

Patients undergoing elective open colorectal surgery were randomised into the lidocaine group or control group. The lidocaine group received 1.5 mg/kg i.v. bolus at induction of anaesthesia immediate

Patients undergoing elective open colorectal surgery were randomised into the lidocaine group or control group. The lidocaine group received 1.5 mg/kg i.v. bolus at induction of anaesthesia immediately followed by 1 mg/kg/hr i.v. infusion for a total of 48 hours duration. On arrival at the post-anaesthesia care unit (PACU), all patients were connected to an i.v. fentanyl patient-controlled analgesia (PCA) pump (20 mcg bolus, 5 min lockout, maximum dose 240 mcg/hr). PCA fentanyl consumption and numerical pain rating scale (NRS, 0-10) at rest were recorded by a blinded non-study nurse at 30min, 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours post-surgery. A blinded non-study pain physician monitored the patient daily, and adjusted the PCA dose if pain was not controlled.


Locations(2)

St Vincent's Private Hospital (Darlinghurst) - Darlinghurst

NSW, Australia

St Vincent's Hospital (Darlinghurst) - Darlinghurst

NSW, Australia

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ACTRN12616000478415


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