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NCT Number: NCT03677817

Perioperative Lidocaine Administration in Thoracoscopic Surgery for Improved Postoperative Pain Control

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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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Division of Thoracic Surgery,University Hospital of Basel

Basel, 4031, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine

Drug

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%

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Sep 19, 2018
Registry last updated
Sep 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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