Perioperative Lidocaine Administration in Thoracoscopic Surgery for Improved Postoperative Pain Control

University Hospital, Basel, Switzerland113 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

113

Conditions

Postoperative Pain

Interventions

LidocaineDRUG

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

NaCl 0,9%DRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Division of Thoracic Surgery,University Hospital of Basel

Basel, Switzerland

Outcomes

Primary Outcomes

Change in total morphine consumption (TMC)

change in total morphine consumption (TMC) via Patient Controlled Analgesia (PCA)

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

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 \[100-mm scale\])

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

Secondary Outcomes

Duration of hospital stay

length of hospital stay (in days)

Time frame: from day of surgery until day of discharge from hospital (an average of 2 days)

time to first defecation - Defined as the time from skin closure to the time of first defecation

time to first defecation - Defined as the time from skin closure to the time of time to first defecation (measured in hours)

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)

Change in chronic pain

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 \[100-mm scale\])

Time frame: 2 weeks, 3 months and 6 months after surgery

occurrence of nausea and/or vomiting

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.