Effects of Intravenous Lidocaine on Transperitoneal Laparoscopic Urological Surgery
Primary Purpose
Pain, Fatigue
Status
Completed
Phase
Phase 3
Locations
Switzerland
Study Type
Interventional
Intervention
lidocaine
placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Pain focused on measuring intravenous lidocaine, laparoscopic urological surgery, hospital stay, pain, fatigue, length of stay
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
Sites / Locations
- Dep. of Urology, Bern University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
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
NaCl 0.9% as a bolus 1.5mg/kg, then intraoperative 2mg/kg/h and postoperative 1.3mg/kg/h during 24h
Outcomes
Primary Outcome Measures
Hospital stay
Secondary Outcome Measures
change in pain score
changes in fatigue score
PONV
time to first episode of flatus and defecation
changes in metabolic and inflammatory responses (cortisol, glc, CRP and procalcitonin)
Full Information
NCT ID
NCT00789620
First Posted
November 11, 2008
Last Updated
March 23, 2011
Sponsor
Insel Gruppe AG, University Hospital Bern
1. Study Identification
Unique Protocol Identification Number
NCT00789620
Brief Title
Effects of Intravenous Lidocaine on Transperitoneal Laparoscopic Urological Surgery
Official Title
Effects of Intravenous Lidocaine on Transperitoneal Laparoscopic Urological Surgery: A Prospective, Randomised, Placebo Controlled, Double-blind, Phase III Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Fatigue
Keywords
intravenous lidocaine, laparoscopic urological surgery, hospital stay, pain, fatigue, length of stay
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
76 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
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
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
NaCl 0.9% as a bolus 1.5mg/kg, then intraoperative 2mg/kg/h and postoperative 1.3mg/kg/h during 24h
Intervention Type
Drug
Intervention Name(s)
lidocaine
Intervention Description
1.5 mg/kg as Bolus intraoperative: 2 mg/kg/h postoperative: 1.3mg/kg/h during 24h
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Bolus 0.15 ml/kg NaCl 0.9% NaCl 0.2 ml/kg/h Perfusor NaCl 0.9% 0.13 ml/kg/h Perfusor
Primary Outcome Measure Information:
Title
Hospital stay
Time Frame
end of hospitalisation
Secondary Outcome Measure Information:
Title
change in pain score
Time Frame
2 and 4 h postop and 3*/d on day 1 and 2
Title
changes in fatigue score
Time Frame
2 and 4 h postop and 3*/d on day 1 and 2
Title
PONV
Time Frame
2 and 4 h postop and 3*/d on day 1 and 2
Title
time to first episode of flatus and defecation
Time Frame
2 and 4 h postop and 3*/d on day 1 and 2
Title
changes in metabolic and inflammatory responses (cortisol, glc, CRP and procalcitonin)
Time Frame
preoperatively and on day 1 and 2 in the morning
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Y Wüthrich, MD
Organizational Affiliation
Dep. of Anesthesiology and pain service, Bern University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dep. of Urology, Bern University Hospital
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
22907609
Citation
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.
Results Reference
derived
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Effects of Intravenous Lidocaine on Transperitoneal Laparoscopic Urological Surgery
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