- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00789620
Effects of Intravenous Lidocaine on Transperitoneal Laparoscopic Urological Surgery
Effects of Intravenous Lidocaine on Transperitoneal Laparoscopic Urological Surgery: A Prospective, Randomised, Placebo Controlled, Double-blind, Phase III Study
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
-
-
-
Bern, Schweiz, 3010
- Dep. of Urology, Bern University Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: 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
|
1.5 mg/kg as Bolus intraoperative: 2 mg/kg/h postoperative: 1.3mg/kg/h during 24h
|
Placebo komparator: 2
NaCl 0.9% as a bolus 1.5mg/kg, then intraoperative 2mg/kg/h and postoperative 1.3mg/kg/h during 24h
|
Bolus 0.15 ml/kg NaCl 0.9% NaCl 0.2 ml/kg/h Perfusor NaCl 0.9% 0.13 ml/kg/h Perfusor
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Hospital stay
Tidsramme: end of hospitalisation
|
end of hospitalisation
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
change in pain score
Tidsramme: 2 and 4 h postop and 3*/d on day 1 and 2
|
2 and 4 h postop and 3*/d on day 1 and 2
|
changes in fatigue score
Tidsramme: 2 and 4 h postop and 3*/d on day 1 and 2
|
2 and 4 h postop and 3*/d on day 1 and 2
|
PONV
Tidsramme: 2 and 4 h postop and 3*/d on day 1 and 2
|
2 and 4 h postop and 3*/d on day 1 and 2
|
time to first episode of flatus and defecation
Tidsramme: 2 and 4 h postop and 3*/d on day 1 and 2
|
2 and 4 h postop and 3*/d on day 1 and 2
|
changes in metabolic and inflammatory responses (cortisol, glc, CRP and procalcitonin)
Tidsramme: preoperatively and on day 1 and 2 in the morning
|
preoperatively and on day 1 and 2 in the morning
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Patrick Y Wüthrich, MD, Dep. of Anesthesiology and pain service, Bern University Hospital
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Træthed
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Anti-arytmimidler
- Depressive midler til centralnervesystemet
- Agenter fra det perifere nervesystem
- Sensoriske systemagenter
- Bedøvelsesmidler
- Membrantransportmodulatorer
- Bedøvelsesmidler, lokale
- Spændingsstyret natriumkanalblokkere
- Natriumkanalblokkere
- Lidokain
Andre undersøgelses-id-numre
- KEK_155_08
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