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

Miodrag Filipovic, Prof. Dr. med.

Status and phase: Completed; Phase 3

Conditions: Pain, Postoperative

Treatments: Drug: Saline Solution; Drug: Lidocaine Hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT03667001

CTU 17/026

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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140 participants in 2 patient groups, including a placebo group

Lidocaine Hydrochloride

Experimental group

Description:

* 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

Treatment:

Drug: Lidocaine Hydrochloride

Saline Solution

Placebo Comparator group

Description:

* 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

Treatment:

Drug: Saline Solution