Clinical trial NCT03667001: Comparing Analgesic Efficacy of Systemic Lidocaine Against Placebo in General Anesthesia in Bariatric Surgery
Official title: Comparing Analgesic Efficacy of Systemic Lidocaine Against Placebo in General Anesthesia in Bariatric Surgery: Prospective, Randomized, Double-blinded, Placebo Controlled, Mono-Center Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain, Postoperative
Keywords: systemic lidocain
Lead sponsor: Cantonal Hospital of St. Gallen
Sponsor class: OTHER
First posted: 2018-09-12
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* elective laparoscopic bariatric surgery
* ASA classification I - III
* age 18 - 80
* given informed consent

Exclusion Criteria:

* no written consent
* allergy to the investigational product
* cardiac arrhythmia (pacemaker)
* liver dysfunction (Child-Pugh classification A, B or C)
* pregnancy
* central nervous disease
* chronic pain and pre-existing opiate prescription
* expected non-compliance
* drug/alcohol abuse

Primary outcomes:
measure: Postoperative VAS/NRS Score
timeFrame: 0 - 4 hours after surgery
Secondary outcomes:
measure: Average experienced maximal pain during the first four hours and 48 hours after Surgery
timeFrame: 0 - 48 hours after surgery
measure: Occurence of Postoperative Nausea and Vomiting after Surgery
timeFrame: 0 - 48 hours after surgery
measure: Time to first Defecation
timeFrame: 0 - 48 hours after surgery
measure: Duration of Hospitalization
timeFrame: 0 - 48 hours after surgery
measure: Total Amount of Opiate Consumption
timeFrame: 0 - 48 hours after surgery
Other outcomes:
Locations:
city: St. Gallen
country: Switzerland
facility: Cantonal Hospital of St. Gallen
Study officials:
affiliation: Deputy Head of the Clinic for Anesthesiology & Intensive Care
name: Miodrag Filipovic, Prof.Dr.med.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Weibel S, Jokinen J, Pace NL, Schnabel A, Hollmann MW, Hahnenkamp K, Eberhart LH, Poepping DM, Afshari A, Kranke P. Efficacy and safety of intravenous lidocaine for postoperative analgesia and recovery after surgery: a systematic review with trial sequential analysis. Br J Anaesth. 2016 Jun;116(6):770-83. doi: 10.1093/bja/aew101.
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