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| Sponsored by: |
University Hospital Inselspital, Berne |
|---|---|
| Information provided by: | University Hospital Inselspital, Berne |
| ClinicalTrials.gov Identifier: | NCT00789620 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pain Fatigue |
Drug: lidocaine Drug: placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Efficacy Study |
| Official Title: | Effects of Intravenous Lidocaine on Transperitoneal Laparoscopic Urological Surgery: A Prospective, Randomised, Placebo Controlled, Double-Blind, Phase III Study |
| Estimated Enrollment: | 76 |
| Study Start Date: | November 2008 |
| Estimated Study Completion Date: | November 2011 |
| Estimated Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Lidocaine 1% administrated as a bolus of 1.5 mg/kg, then intraoperative 2mg/kg/h and postoperative 1.3mg/kg/h during 24 h
|
Drug: lidocaine
1.5 mg/kg as Bolus intraoperative: 2 mg/kg/h postoperative: 1.3mg/kg/h during 24h
|
|
2: Placebo Comparator
NaCl 0.9% as a bolus 1.5mg/kg, then intraoperative 2mg/kg/h and postoperative 1.3mg/kg/h during 24h
|
Drug: placebo
Bolus 0.15 ml/kg NaCl 0.9% NaCl 0.2 ml/kg/h Perfusor NaCl 0.9% 0.13 ml/kg/h Perfusor
|
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Switzerland | |
| Dep. of Urology, Bern University Hospital | |
| Bern, Switzerland, 3010 | |
| Principal Investigator: | Patrick Y Wüthrich, MD | Dep. of Anesthesiology and pain service, Bern University Hospital |
More Information
| Responsible Party: | Dep. of anesthesiology and pain service, Bern University Hospital ( Patrick Y Wüthrich MD ) |
| Study ID Numbers: | KEK_155_08 |
| Study First Received: | November 11, 2008 |
| Last Updated: | November 12, 2008 |
| ClinicalTrials.gov Identifier: | NCT00789620 |
| Health Authority: | Switzerland: Swissmedic |
|
intravenous lidocaine laparoscopic urological surgery hospital stay |
pain fatigue length of stay |
|
Signs and Symptoms Fatigue Lidocaine Pain |
|
Sensory System Agents Therapeutic Uses Physiological Effects of Drugs Central Nervous System Depressants Anesthetics Cardiovascular Agents |
Anti-Arrhythmia Agents Peripheral Nervous System Agents Central Nervous System Agents Pharmacologic Actions Anesthetics, Local |
