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NCT Number: NCT04480281

Intravenous Lidocaine in Open Lung Resection Surgery

Management of postoperative pain in 2020 remains a challenge for anesthesiologists in the perioperative period. Lidocaine is an amide local anesthetic, it is one of the oldest adjuvant analgesics and is known to possess analgesic, anti-hyperalgesic and anti-inflammatory properties. Lidocaine is proven to be as effective as epidural analgesia in colorectal surgery.

However, no study has evaluated the effect of a continuous lidocaine infusion for open lung resection in the post-operative period. The present study aims to evaluate the influence of IV lidocaine given during and 24 hours after surgery, on pain scores, opioid consumption, and possible benefits on patient outcome via the opioid-sparing effect in open thoracic surgery

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hotel Dieu de France

Beirut, 1104 2020, Lebanon

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • American society of anesthesiologists (ASA) scores of I, II or III.
  • Left or right posterolateral thoracotomy with postoperative monitoring in the intensive care unit (ICU) for at least 24 hours (h).

Exclusion criteria

  • patient's refusal to participate
  • ASA score of IV or higher
  • severe hepatic or renal insufficiency
  • allergy to lidocaine, morphine or NSAIDs
  • cardiac arrhythmias or
  • epilepsy,
  • delayed extubation for more than 2 h postoperatively
  • urgent surgery

Treatment and study plan

Lidocaine IV

Drug

Patients in the Lidocaine group received a bolus of lidocaine 1% 1.5mg/kg at the induction of general anesthesia followed by a continuous infusion of lidocaine 1% 2mg/kg/h just before surgical incision and continued until 24h after the surgery

normal saline

Drug

Patients in Group Placebo received an equal bolus volume of normal saline solution at induction, and then a continuous infusion started before surgical incision and maintained up until 24h postoperatively

Primary outcomes

  1. Opioid consumption in the post operative period

    Time frame: Doses were measured for twenty four hours in the post operative period

    Total dose of morphine in the post operative period is measured for patients in both arms

  2. Pain scores at rest and at cough

    Time frame: Measurements were made for 24 hours in the post operative period

    Analogue visual scale ( a 10cm scale , zero representing no pain and 10 representing the worst imaginable pain)) was used to measure pain scores for each patient at rest and at cough

Secondary outcomes

  1. Pulmonary complications

    Time frame: Measurements were recorded for 24 hours in the post operative period

    Arterial partial carbon dioxide pressure (PCO2) measurements were recorded for patients in both arms

Sponsors and collaborators

Lead sponsor

Saint-Joseph University

Other

Registry information

Official study title

Intravenous Lidocaine Reduces Pain Scores and Opioid Consumption in Open Lung Resection Surgery: A Prospective Randomized Double-Blind Controlled Trial

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 21, 2020
Registry last updated
Jul 21, 2020

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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