Clinical trial NCT03677817: Perioperative Lidocaine Administration in Thoracoscopic Surgery for Improved Postoperative Pain Control
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postoperative Pain
Keywords: thoracoscopic surgery
Perioperative intravenous lidocaine administration
Lidocaine
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2018-09-19
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .

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.

Eligibility 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

Primary outcomes:
measure: Change in total morphine consumption (TMC)
timeFrame: within the first 24 hours, measured at 1 hour, 2 hours, 4 hours, 8 hours, 16 hours, and 24 hours after skin closure
measure: change in pain intensity
timeFrame: 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:
measure: Duration of hospital stay
timeFrame: from day of surgery until day of discharge from hospital (an average of 2 days)
measure: time to first defecation - Defined as the time from skin closure to the time of first defecation
timeFrame: From timepoint of surgical skin closure (end of surgery) to the timepoint of first defecation after surgical skin closure (an average of 2 days)
measure: Change in chronic pain
timeFrame: 2 weeks, 3 months and 6 months after surgery
measure: occurrence of nausea and/or vomiting
timeFrame: from the date of surgery until the date of discharge from hospital (an average of 2 days)
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Division of Thoracic Surgery,University Hospital of Basel
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Didier Lardinois, Prof. Dr. MD
role: PRINCIPAL_INVESTIGATOR
References: