Perioperative Lidocaine Administration in Thoracoscopic Surgery for Improved Postoperative Pain Control

University Hospital Basel

Status and phase: Completed; Phase 3

Conditions: Postoperative Pain

Treatments: Drug: Lidocaine; Drug: NaCl 0,9%

Study type: Interventional

Funder types: Other

Identifiers

NCT03677817

2016-00259 ch15Toffel;

Details and patient eligibility

About

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

Full 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.

Enrollment: 113 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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113 participants in 2 patient groups, including a placebo group

Lidocaine

Active Comparator group

Description:

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

Treatment:

Drug: Lidocaine

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: NaCl 0,9%