Comparing Analgesic Efficacy of Systemic Lidocaine Against Placebo in General Anesthesia in Bariatric Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparing Analgesic Efficacy of Systemic Lidocaine Against Placebo in General Anesthesia in Bariatric Surgery: Prospective, Randomized, Double-blinded, Placebo Controlled, Mono-Center Study

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Lidocaine Hydrochloride
* Drug: Saline Solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidocaine Hydrochloride<br>1.5 mg/kg lean body mass lidocaine (lidocaine 1%) bolus I.V. as general anesthesia steady state concentration is accomplished 1.5 mg/kg lean body mass/h lidocaine I.V. with beginning of surgical procedures after completion of surgery: transfer to PACU, pain evaluation for 48 hours duration of intervention: lidocaine infusion up to four hours from completion of surgery, or till transfer to surgical ward | Drug: Lidocaine Hydrochloride<br>* 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.<br>* Other names: Lidocaine Group;|
| Placebo Comparator: Saline Solution<br>0.15 ml/kg lean body mass saline 0.9% bolus I.V. as general anesthesia steady state concentration is accomplished 0.15 ml/kg lean body mass/h saline 0.9% I.V. with beginning of surgical procedure after completion of surgery: transfer to PACU, pain evaluation for 48 hours duration of intervention: saline infusion up to four hours from completion of surgery, or till transfer to surgical ward | Drug: Saline Solution<br>* 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.<br>* Other names: Placebo Group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative VAS/NRS Score | Any development of VAS/NRS score > 3 (Visual Analog Scale/Numeric Rating Scale ranging from minimum 0 to maximum 10 points, with 0 points as no pain to 10 points as severe pain) , in hourly measurements within the first four hours after completion of bariatric surgery to evaluate the pain experienced by patients after the surgical intervention | 0 - 4 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average experienced maximal pain during the first four hours and 48 hours after Surgery | Average experienced maximal pain during the first four hours and 48 hours (in hourly measurements on post anesthesia care unit (PACU) and in eight-hourly measurements on surgical ward) is assessed by VAS/NRS score (Visual Analog Scale/Numeric Rating Scale ranging from minimum 0 to maximum 10 points, with 0 points as no pain to 10 points as severe pain). | 0 - 48 hours after surgery | 
| Occurence of Postoperative Nausea and Vomiting after Surgery | Any event of postoperative nausea and vomiting (PONV) (subdivided by event of no nausea (PONV = 0), event of nausea without vomiting (PONV = 1) and event of nausea with vomiting (PONV = 2)) during first 48 hours after completion of surgery | 0 - 48 hours after surgery | 
| Time to first Defecation | Time to first defecation (quantified in hours) | 0 - 48 hours after surgery | 
| Duration of Hospitalization | Duration of hospitalization (quantified in days) | 0 - 48 hours after surgery | 
| Total Amount of Opiate Consumption | The total amount of opiates (given during surgery and on PACU and administrated by nurse controlled analgesia on surgical ward) | 0 - 48 hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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systemic lidocain