Pain Clinical Trial
Official title:
Effects of Intravenous Lidocaine on Transperitoneal Laparoscopic Urological Surgery: A Prospective, Randomised, Placebo Controlled, Double-blind, Phase III Study
Effective perioperative analgesia is the key to postoperative rehabilitation. An intriguing body of evidence suggests that short-term administration of intravenous lidocaine may produce pain relief that far exceeds both the duration of infusion and the half-life of the drug. When pain relief is provided, concomitant anal-gesic medication can be reduced, side effects from pain relieving medication minimized with a potential for a more rapid postoperative recovery and less complications. IV application of lidocaine should de-crease the duration of bowel dysfunction. We hypothesise that i.v. application of lidocaine in a standard antiarrythmic dose can significantly improve acute rehabilitation after laparoscopic urological surgery and so shorten the hospital stay (primary outcome). We expect that the intraoperative inflammatory response can significantly be reduced.
Effective perioperative analgesia is the key to postoperative rehabilitation. It has been
suggested that a decrease in postoperative pain and opioid use ameliorates the return of
normal bowel function after general surgery. Conventional analgesic treatment involves the
use of intravenous, oral and transdermal formulations of drugs. Repetitive administration is
required for sustained pain relief. Common side effects (postoperative nausea and vomiting,
postoperative ileus) of these analgesics may have a detrimental effect on postoperative
recovery and led to a prolonged hospital stay. An intriguing body of evidence suggests that
short-term administration of intravenous lidocaine may produce pain relief that by far
exceeds both the duration of the infusion and the half-life of the drug thus reducing
concomitant analgesic medication can be reduced and its side effects enabling a more rapid
postoperative recovery with less complications. Lidocaine is a commonly used local
anesthetic and an antiarrythmic agent. It has been shown to preserve neuroelectric function
in animal experiments. Intraoperative administration of lidocaine in a standard
antiarrythmic dose has been shown to decrease the occurrence of cognitive dysfunction in the
early postoperative period after coronary artery bypass surgery. Lidocaine can induce a
significant re-duction of several components of chronic pain in patients with poststroke or
spinal cord injury related pain. Sodium channel blockers (e.g. lidocaine) are approved for
intravenous administration in the treat-ment of neuropathic pain states. In addition
lidocaine has anti-inflammatory properties and preclinical studies have suggested
antihyperalgesic effects on the peripheral and central nervous system. Lidocaine decreases
the minimum alveolar concentration (MAC) of inhaled anesthetics and has been used clinically
to reduce the requirements for other anesthetic drugs. IV application of lidocaine is said
to decrease the duration of bowel dysfunction and postoperative pain intensity.
We hypothesise that i.v. application of lidocaine in a standard antiarrythmic dose can
significantly improve acute rehabilitation after laparoscopic urological surgery and so
shorten the hospital stay. We expect that the intraoperative inflammatory response can
significantly be reduced.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
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