Perioperative Lidocaine Administration in Thoracoscopic Surgery for Improved Postoperative Pain Control

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

113 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-03

Study Completion Date

2022-08-28

Brief Summary

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

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Detailed Description

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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.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Lidocaine

Intervention Type DRUG

regimen of lidocaine administration of 1,5 mg/kg, IV bolus, followed by continuous infusion at 3,0 mg/kg/h

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

Group Type PLACEBO_COMPARATOR

NaCl 0,9%

Intervention Type DRUG

IV bolus of NaCl 0,9%, followed by continuous infusion of NaCl 0,9%

Interventions

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Lidocaine

regimen of lidocaine administration of 1,5 mg/kg, IV bolus, followed by continuous infusion at 3,0 mg/kg/h

Intervention Type DRUG

NaCl 0,9%

IV bolus of NaCl 0,9%, followed by continuous infusion of NaCl 0,9%

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No