Comparing Analgesic Efficacy of Systemic Lidocaine Against Placebo in General Anesthesia in Bariatric Surgery
- Conditions
- Pain, Postoperative
- Interventions
- Drug: Saline Solution
- Registration Number
- NCT03667001
- Lead Sponsor
- Miodrag Filipovic, Prof. Dr. med.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 140
- elective laparoscopic bariatric surgery
- ASA classification I - III
- age 18 - 80
- given informed consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Saline Solution Saline Solution * 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 Lidocaine Hydrochloride Lidocaine Hydrochloride * 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
- Primary Outcome Measures
Name Time Method Postoperative VAS/NRS Score 0 - 4 hours after surgery 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
- Secondary Outcome Measures
Name Time Method Time to first Defecation 0 - 48 hours after surgery Time to first defecation (quantified in hours)
Duration of Hospitalization 0 - 48 hours after surgery Duration of hospitalization (quantified in days)
Total Amount of Opiate Consumption 0 - 48 hours after surgery The total amount of opiates (given during surgery and on PACU and administrated by nurse controlled analgesia on surgical ward)
Average experienced maximal pain during the first four hours and 48 hours after Surgery 0 - 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").
Occurence of Postoperative Nausea and Vomiting after Surgery 0 - 48 hours 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
Trial Locations
- Locations (1)
Cantonal Hospital of St. Gallen
🇨🇭St. Gallen, Switzerland
Cantonal Hospital of St. Gallen🇨🇭St. Gallen, Switzerland