Comparing Analgesic Efficacy of Systemic Lidocaine Against Placebo in General Anesthesia in Bariatric Surgery
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      The investigators plan to evaluate the analgesic effect of systemic Lidocaine in addition to
      general anesthesia during bariatric surgery. Patients will be subdivided into a "Lidocaine
      group" and a "Control group".

      The primary outcome will be the proportion of patients suffering from higher pain intensity
      within the first four hours after bariatric surgery.

      Secondary outcomes include the average maximal pain intensity during first four hours and
      during 48 hours, total opiate consumption, occurence of postoperative nausea and vomiting,
      time to first defecation and total time spent in hospital.
    

Detailed description: 
      Postoperative pain is a common problem in today's surgery, although pain management
      techniques have improved in the last years. Systemic application of lidocaine has gained
      interest since several studies have shown its analgesic, anti-inflammatory and
      antihyperalgesic properties. In this clinical trial the analgesic effect of intravenously
      administrated lidocaine is compared with placebo. Despite longstanding use as an
      antiarrhythmic agent and its use in many clinical trial as analgesic, lidocaine is not
      licensed for this indication and application. Current studies, setting the focus on abdominal
      surgery, indicated that the systemic application of lidocaine was associated with fewer
      intensity of pain at rest and during mobilization and resulted in a decrease of
      patients'opiate consumption.

      The intervention to be studied will either be the additional application of systemic
      lidocaine 1% to general anesthesia in bariatric surgery or the application of placebo.
      Patients, randomly assigned to one study group, will be surveyed for 48 hours after
      completion of surgery, experienced pain, occurrence of PONV, time to first defecation and
      length of hospitalization will be monitored. The population to be studied will include 140
      patients listed for bariatric surgery at the Kantonsspital St. Gallen. Patients, medical
      practitioner, nurses and investigators will be blinded. Each patient will self-evaluate his
      maximal experienced pain eight-hourly during a sequence of 48 hours after completion of
      surgery.
    

Intervention name(s): Lidocaine Hydrochloride; Saline Solution
Intervention type(s): Drug; Drug
Intervention description(s): The intervention to be studied will be the additional application of systemic lidocaine 1% dosed 1.5 ml/kg LBM to general anesthesia in bariatric surgery. Patients, randomly assigned to one study group, will be surveyed for 48 hours after completion of surgery, experienced pain, occurrence of PONV, time to first defecation and length of hospitalization will be monitored. Patients, medical practitioner, nurses and investigators will be blinded by utilization of equal appearance and packing of IMPs, which will be fabricated individually for each patient and on request one to two days before surgery by the pharmacy. Each patient will self-evaluate his maximal experienced pain eight-hourly during a sequence of 48 hours after completion of surgery.; The intervention to be studied will be the additional application of NaCl 0.9% dosed 1.5 ml/kg LBM to general anesthesia in bariatric surgery as a placebo. Patients, randomly assigned to one study group, will be surveyed for 48 hours after completion of surgery, experienced pain, occurrence of PONV, time to first defecation and length of hospitalization will be monitored. Each patient will self-evaluate his maximal experienced pain eight-hourly during a sequence of 48 hours after completion of surgery.
Other intervention name(s): Lidocaine Group; Placebo Group
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The investigators plan to evaluate the analgesic effect of systemic Lidocaine in Addition to general anesthesia during bariatric surgery.
Lidocaine group: perioperative application of systemic Lidocaine up to four hours from end of surgical procedures.
Control group: perioperative application of Placebo (NaCl 0.9%) up to four hours from end of surgical procedures.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: systemic lidocain