Perioperative Lidocaine Administration in Thoracoscopic Surgery for Improved Postoperative Pain Control

• ClinicalTrials.gov Identifier: NCT03677817
• Recruitment Status: Recruiting
• First Posted: September 19, 2018
• Last Update Posted: August 25, 2021
• Sponsor: University Hospital, Basel, Switzerland
• Information provided by (Responsible Party): University Hospital, Basel, Switzerland

Study Description

Brief Summary:

Placebo-controlled study to analyze the effect of perioperative intravenous lidocaine administration on total morphine consumption (TMC) and on pain intensity in thoracoscopic surgery .

Condition or disease	Intervention/treatment	Phase
Postoperative Pain	Drug: Lidocaine; Drug: NaCl 0,9%	Phase 3

Detailed Description:

Thoracoscopy (thoracic surgery) is a video-assisted minimally invasive operation in thoracic surgery, which is associated with pain after surgery. Trial drug Lidocaine is approved as pain medication. This placebo-controlled study analyzes the effect of perioperative intravenous lidocaine administration on total morphine consumption (TMC) and on pain intensity in thoracoscopic surgery .

Half of the patients will receive NaCl 0.9% (a saline solution without active ingredient) instead of Lidocaine.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 113 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Prospective, Randomized, Double Blind, Superiority Trial, Evaluating the Effect of Perioperative Lidocaine on Postoperative Opioid Consumption, Pain Ratings, Duration of Hospital Stay, Time to First Defecation, 30-day Mortality and Development of Chronic Pain in Patients Undergoing Video-assisted Thoracoscopic Procedures
• Actual Study Start Date: April 3, 2019
• Estimated Primary Completion Date: December 2022
• Estimated Study Completion Date: December 2022

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Lidocaine; perioperative IV administration regimen of lidocaine will be as follows: 1.5 mg/kg IV induction bolus dose (before intubation and at least 30 minutes before incision) followed by continuous infusion of 3.mg/kg/h, until 2 hours after skin closure	Drug: Lidocaine; regimen of lidocaine administration of 1,5 mg/kg, IV bolus, followed by continuous infusion at 3,0 mg/kg/h
Placebo Comparator: Placebo; perioperative IV administration regimen of placebo solution (NaCl 0,9%) will be as follows: induction bolus (before intubation and at least 30 minutes before incision) followed by continuous infusion of placebo solution (NaCl 0,9%) until 2 hours after skin closure	Drug: NaCl 0,9%; IV bolus of NaCl 0,9%, followed by continuous infusion of NaCl 0,9%

Outcome Measures

Primary Outcome Measures :

1. Change in total morphine consumption (TMC) [ Time Frame: within the first 24 hours, measured at 1 hour, 2 hours, 4 hours, 8 hours, 16 hours, and 24 hours after skin closure ]
   change in total morphine consumption (TMC) via Patient Controlled Analgesia (PCA)
2. change in pain intensity [ Time Frame: within the first 24 hours, measured at 1 hour, 2 hours, 4 hours, 8 hours, 16 hours, and 24 hours after skin closure ]
   change in pain intensity of at least 1.5 units on the Visual Analogue Scale (VAS). The pain VAS is a unidimensional measure of pain intensity; the scale is anchored by "no pain" (score of 0) and "worst imaginable pain" (score of 100 [100-mm scale])

Secondary Outcome Measures :

1. Duration of hospital stay [ Time Frame: from day of surgery until day of discharge from hospital (an average of 2 days) ]
   length of hospital stay (in days)
2. time to first defecation - Defined as the time from skin closure to the time of first defecation [ Time Frame: From timepoint of surgical skin closure (end of surgery) to the timepoint of first defecation after surgical skin closure (an average of 2 days) ]
   time to first defecation - Defined as the time from skin closure to the time of time to first defecation (measured in hours)
3. Change in chronic pain [ Time Frame: 2 weeks, 3 months and 6 months after surgery ]
   Change in pain intensity (with and without coughing) on the Visual Analogue Scale (VAS). The pain VAS is a unidimensional measure of pain intensity; the scale is anchored by "no pain" (score of 0) and "worst imaginable pain" (score of 100 [100-mm scale])
4. occurrence of nausea and/or vomiting [ Time Frame: from the date of surgery until the date of discharge from hospital (an average of 2 days) ]
   occurrence of nausea and/or vomiting

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Patients undergoing video-assisted thoracoscopic procedures under general anaesthesia.
• American Society of Anesthesiologists (ASA) physical Status classes I to III
• age ≥ 18 years
• Patient informed consent

Exclusion Criteria:

• Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product
• Contraindications to self-administration of opioids
• Women who are pregnant or breast feeding
• Steroid therapy
• Chronic pain therapy
• Atrioventricular block grade II to III
• Congestive heart failure
• Liver insufficiency
• Known or suspected non-compliance, drug or alcohol abuse
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia
• Participation in another study with investigational drug within the 30 days preceding and during the present study,
• Enrolment of the investigator, his/her family members, employees and other dependent persons

Contacts and Locations

Contacts

Contact: Aljaz Hojski, Dr. med; +41 61 55 65282; aljaz.hojski@usb.ch

Contact: Didier Lardinois, Prof. Dr. MD; +41 61 328 7799; didier.lardinois@usb.ch

Locations

Switzerland

Division of Thoracic Surgery,University Hospital of Basel; Recruiting

Basel, Switzerland, 4031

Contact: Aljaz Hojski, Dr. med

Contact: Stoermer Heike, Dr. med. +41 61 328 71 63 heike.stoermer@usb.ch

Principal Investigator: Didier Lardinois, Prof.

Sub-Investigator: Aljaz Hojski, Dr.

Sub-Investigator: Sandrine Dackam, Dr.

Sub-Investigator: Kaufmann Mark, Dr.

Sub-Investigator: Lampart Andreas, Dr.

Sub-Investigator: Wiese Mark, Dr.

Sub-Investigator: Bolliger Daniel, Prof.

Sub-Investigator: Seeberger Esther

Sponsors and Collaborators

University Hospital, Basel, Switzerland

Investigators

• Principal Investigator: Didier Lardinois, Prof. Dr. MD; University Hospital, Basel, Switzerland

More Information

• Responsible Party: University Hospital, Basel, Switzerland
• ClinicalTrials.gov Identifier: NCT03677817
• Other Study ID Numbers: 2016-00259; ch15Toffel
• First Posted: September 19, 2018
• Last Update Posted: August 25, 2021
• Last Verified: August 2021

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

Keywords provided by University Hospital, Basel, Switzerland:

thoracoscopic surgery; Perioperative intravenous lidocaine administration; Lidocaine

Additional relevant MeSH terms:

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