Effects of Intravenous Lidocaine on Transperitoneal Laparoscopic Urological Surgery

NCT ID: NCT00789620

Last Updated: 2011-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2011-03-31

Brief Summary

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.

Detailed Description

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.

Conditions

Pain; Fatigue

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

1

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

Group Type: ACTIVE_COMPARATOR

lidocaine

Intervention Type: DRUG

1.5 mg/kg as Bolus intraoperative: 2 mg/kg/h postoperative: 1.3mg/kg/h during 24h

2

NaCl 0.9% as a bolus 1.5mg/kg, then intraoperative 2mg/kg/h and postoperative 1.3mg/kg/h during 24h

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Bolus 0.15 ml/kg NaCl 0.9% NaCl 0.2 ml/kg/h Perfusor NaCl 0.9% 0.13 ml/kg/h Perfusor

Interventions

lidocaine

1.5 mg/kg as Bolus intraoperative: 2 mg/kg/h postoperative: 1.3mg/kg/h during 24h

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Written informed consent
• ASA 1 to 3
• Laparoscopic transperitoneal urological surgery

Exclusion Criteria

• Liver insufficiency
• Steroid therapy
• Chronic opioid therapy
• Allergy to lidocaine
• Pre-existing disorder of the gastrointestinal tract
• AV-block II-III, sinusbradycardia, heart insufficiency, long QT-syndrome
• Pregnancy

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Dep. of anesthesiology and pain service, Bern University Hospital

Principal Investigators

Patrick Y Wüthrich, MD

Role: PRINCIPAL_INVESTIGATOR

Dep. of Anesthesiology and pain service, Bern University Hospital

Locations

Dep. of Urology, Bern University Hospital

Bern, , Switzerland

Countries

Switzerland

References

Wuethrich PY, Romero J, Burkhard FC, Curatolo M. No benefit from perioperative intravenous lidocaine in laparoscopic renal surgery: a randomised, placebo-controlled study. Eur J Anaesthesiol. 2012 Nov;29(11):537-43. doi: 10.1097/EJA.0b013e328356bad6.

Reference Type: DERIVED

PMID: 22907609 (View on PubMed)

Other Identifiers

KEK_155_08

Identifier Type: -

Identifier Source: org_study_id