- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03667001
Comparing Analgesic Efficacy of Systemic Lidocaine Against Placebo in General Anesthesia in Bariatric Surgery (COALAS)
Comparing Analgesic Efficacy of Systemic Lidocaine Against Placebo in General Anesthesia in Bariatric Surgery: Prospective, Randomized, Double-blinded, Placebo Controlled, Mono-Center Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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St. Gallen, Switzerland, 9007
- Cantonal Hospital of St. Gallen
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lidocaine Hydrochloride
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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.
Other Names:
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Placebo Comparator: Saline Solution
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative VAS/NRS Score
Time Frame: 0 - 4 hours after surgery
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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
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0 - 4 hours after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Average experienced maximal pain during the first four hours and 48 hours after Surgery
Time Frame: 0 - 48 hours after surgery
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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").
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0 - 48 hours after surgery
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Occurence of Postoperative Nausea and Vomiting after Surgery
Time Frame: 0 - 48 hours after surgery
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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
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0 - 48 hours after surgery
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Time to first Defecation
Time Frame: 0 - 48 hours after surgery
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Time to first defecation (quantified in hours)
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0 - 48 hours after surgery
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Duration of Hospitalization
Time Frame: 0 - 48 hours after surgery
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Duration of hospitalization (quantified in days)
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0 - 48 hours after surgery
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Total Amount of Opiate Consumption
Time Frame: 0 - 48 hours after surgery
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The total amount of opiates (given during surgery and on PACU and administrated by nurse controlled analgesia on surgical ward)
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0 - 48 hours after surgery
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Collaborators and Investigators
Investigators
- Principal Investigator: Miodrag Filipovic, Prof.Dr.med., Deputy Head of the Clinic for Anesthesiology & Intensive Care
Publications and helpful links
General Publications
- Vigneault L, Turgeon AF, Cote D, Lauzier F, Zarychanski R, Moore L, McIntyre LA, Nicole PC, Fergusson DA. Perioperative intravenous lidocaine infusion for postoperative pain control: a meta-analysis of randomized controlled trials. Can J Anaesth. 2011 Jan;58(1):22-37. doi: 10.1007/s12630-010-9407-0.
- Herroeder S, Pecher S, Schonherr ME, Kaulitz G, Hahnenkamp K, Friess H, Bottiger BW, Bauer H, Dijkgraaf MG, Durieux ME, Hollmann MW. Systemic lidocaine shortens length of hospital stay after colorectal surgery: a double-blinded, randomized, placebo-controlled trial. Ann Surg. 2007 Aug;246(2):192-200. doi: 10.1097/SLA.0b013e31805dac11. Erratum In: Ann Surg. 2009 Apr;249(4):701. Dijkgraaf, Omarcel G W [corrected to Dijkgraaf, Marcel G W].
- 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.
- Groudine SB, Fisher HA, Kaufman RP Jr, Patel MK, Wilkins LJ, Mehta SA, Lumb PD. Intravenous lidocaine speeds the return of bowel function, decreases postoperative pain, and shortens hospital stay in patients undergoing radical retropubic prostatectomy. Anesth Analg. 1998 Feb;86(2):235-9. doi: 10.1097/00000539-199802000-00003.
- De Oliveira GS Jr, Duncan K, Fitzgerald P, Nader A, Gould RW, McCarthy RJ. Systemic lidocaine to improve quality of recovery after laparoscopic bariatric surgery: a randomized double-blinded placebo-controlled trial. Obes Surg. 2014 Feb;24(2):212-8. doi: 10.1007/s11695-013-1077-x.
- McCarthy GC, Megalla SA, Habib AS. Impact of intravenous lidocaine infusion on postoperative analgesia and recovery from surgery: a systematic review of randomized controlled trials. Drugs. 2010 Jun 18;70(9):1149-63. doi: 10.2165/10898560-000000000-00000.
- Cui W, Li Y, Li S, Wang R, Li J. Systemic administration of lidocaine reduces morphine requirements and postoperative pain of patients undergoing thoracic surgery after propofol-remifentanil-based anaesthesia. Eur J Anaesthesiol. 2010 Jan;27(1):41-6. doi: 10.1097/EJA.0b013e32832d5426.
- Janmahasatian S, Duffull SB, Ash S, Ward LC, Byrne NM, Green B. Quantification of lean bodyweight. Clin Pharmacokinet. 2005;44(10):1051-65. doi: 10.2165/00003088-200544100-00004.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Pain, Postoperative
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
Other Study ID Numbers
- CTU 17/026
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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