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

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ClinicalTrials.gov Identifier: NCT03667001

Recruitment Status : Completed

First Posted : September 12, 2018

Last Update Posted : July 28, 2021

Sponsor:

Information provided by (Responsible Party):

Miodrag Filipovic, Prof. Dr. med., Cantonal Hospital of St. Gallen

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pain, Postoperative	Drug: Lidocaine Hydrochloride Drug: Saline Solution	Phase 3

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	140 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
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.
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:	Measures taken to minimize or avoid bias include randomization and blinding of participants after they have given their informed consent. Blinding of medical practitioner and medical personnel will be conducted by provision of equal looking and packing of IMPs, which will be fabricated individually for each patient and on request one to two days before surgery by the pharmacy.
Primary Purpose:	Treatment
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
Actual Study Start Date :	November 16, 2018
Actual Primary Completion Date :	April 1, 2021
Actual Study Completion Date :	April 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Weight Loss Surgery

Drug Information available for: Lidocaine hydrochloride Lidocaine

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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	Drug: Lidocaine Hydrochloride 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 Name: Lidocaine Group
Placebo Comparator: 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	Drug: Saline Solution 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 Name: Placebo Group

Arm

Intervention/treatment

Experimental: 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

Drug: Lidocaine Hydrochloride

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 Name: Lidocaine Group

Placebo Comparator: 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

Drug: Saline Solution

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 Name: Placebo Group

Outcome Measures

Primary Outcome Measures :

Postoperative VAS/NRS Score [ Time Frame: 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 :

Average experienced maximal pain during the first four hours and 48 hours after Surgery [ Time Frame: 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 [ Time Frame: 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
Time to first Defecation [ Time Frame: 0 - 48 hours after surgery ]
Time to first defecation (quantified in hours)
Duration of Hospitalization [ Time Frame: 0 - 48 hours after surgery ]
Duration of hospitalization (quantified in days)
Total Amount of Opiate Consumption [ Time Frame: 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)

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03667001

Locations

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Switzerland
Cantonal Hospital of St. Gallen
St. Gallen, Switzerland, 9007

Sponsors and Collaborators

Miodrag Filipovic, Prof. Dr. med.

Investigators

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Principal Investigator:	Miodrag Filipovic, Prof.Dr.med.	Deputy Head of the Clinic for Anesthesiology & Intensive Care

Study Documents (Full-Text)

Documents provided by Miodrag Filipovic, Prof. Dr. med., Cantonal Hospital of St. Gallen:

Study Protocol and Statistical Analysis Plan [PDF] December 28, 2018

More Information

Publications:

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. Review.

Vigneault L, Turgeon AF, Côté 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. Review.

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.

Herroeder S, Pecher S, Schönherr ME, Kaulitz G, Hahnenkamp K, Friess H, Böttiger 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. Erratum in: Ann Surg. 2009 Apr;249(4):701. Dijkgraaf, Omarcel G W [corrected to Dijkgraaf, Marcel G W].

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.

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. Review.

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.

Janmahasatian S, Duffull SB, Ash S, Ward LC, Byrne NM, Green B. Quantification of lean bodyweight. Clin Pharmacokinet. 2005;44(10):1051-65.

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Responsible Party:	Miodrag Filipovic, Prof. Dr. med., Deputy Head of the Clinic for Anesthesiology and Intensive Care, Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier:	NCT03667001
Other Study ID Numbers:	CTU 17/026
First Posted:	September 12, 2018 Key Record Dates
Last Update Posted:	July 28, 2021
Last Verified:	July 2021

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Miodrag Filipovic, Prof. Dr. med., Cantonal Hospital of St. Gallen:


systemic lidocain

Additional relevant MeSH terms:

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Pain, Postoperative Postoperative Complications Pathologic Processes Pain Neurologic Manifestations Lidocaine Anesthetics, Local Anesthetics Central Nervous System Depressants	Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents Anti-Arrhythmia Agents Voltage-Gated Sodium Channel Blockers Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action

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