Skip to main content
OpenTrials
Completed

NCT Number: NCT03620591

Lidocaine and Analgesia After Laparoscopic Cholecystectomy

The purpose of this study is to evaluate how effective is the intraoperative use of lidocaine to attenuate postoperative pain and opioids consumption after laparoscopic cholecystectomy

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postoperative Pain Neurologic Manifestations Opioid Consumption 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

Not applicable

Primary location

University Hospital of Larissa

Larissa, 41110, Greece

About this study

Acute postoperative pain may predict the development of chronic pain.Recently, the analgesic effect of lidocaine, as a part of a multimodal analgesia, has been evaluated in many studies. They have shown that lidocaine may have a role in the postoperative pain management, as an adjunct.

Acute postoperative pain after laparoscopic cholecystectomy is complex in nature. Postoperative pain is the main complaint and the primary reason for delay discharge after laparoscopic cholecystectomy.The study includes patients undergoing laparoscopic cholecystectomy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ASA physical status I-II
  • Age ≥ 18 years old
  • BMI ≤ 35

Exclusion criteria

  • Allergy in local anesthetics
  • History of liver, kidney or heart failure
  • Existence of chronic pain history or daily analgesics
  • Psychiatric disorders
  • Inability to understand pain assessment

Treatment and study plan

Lidocaine

Drug

Intraoperative administration of lidocaine

Placebo

Drug

Intraoperative administration of normal saline

Primary outcomes

  1. Postoperative opioid consumption

    Time frame: 24 hours after the procedure

    The total dose of tramadol is calculated as mg and administered intravenously.

Secondary outcomes

  1. Postoperative pain

    Time frame: Departure of the patient from the recovery room (0hrs)

    Numeric Rate scale 0-10 (0=no pain to 10=worst imaginable pain)

  2. Postoperative pain

    Time frame: 6 hrs after the procedure

    Numeric Rate scale 0-10 (0=no pain to 10=worst imaginable pain)

  3. Postoperative pain

    Time frame: 12 hrs after the procedure

    Numeric Rate scale 0-10 (0=no pain to 10=worst imaginable pain)

  4. Postoperative pain

    Time frame: 24 hrs after the procedure

    Numeric Rate scale 0-10 (0=no pain to 10=worst imaginable pain)

  5. Incidence of Nausea and Vomiting

    Time frame: 24 hours

    The percentage of patients who had nausea and vomiting during the first 24 hours

  6. Incidence of sedation and respiratory depression

    Time frame: 24 hours

    The percentage of patients who had sedation and respiratory depression during the first 24 hours

  7. Incidence of shoulder pain

    Time frame: 24 hours

    The percentage of patients who had shoulder pain during the first24 hours

  8. Incidence of headache and dizziness

    Time frame: 24 hours

    The percentage of patients who had headache and dizziness during the first 24 hours

  9. Change from baseline Mean Blood Pressure

    Time frame: Intraoperative

    Non-invasive blood pressure measurement by using sphygmomanometer cuff

  10. Change from Baseline Heart Rate

    Time frame: Intraoperative

    Bradycardia, tachycardia during the procedure

  11. Change in depth of anesthesia

    Time frame: Intraoperative

    Maintenance of Bispectral index (BIS) values of 40 to 50

  12. Side effect related to administration of lidocaine

    Time frame: 24 hours

    The percentage of patients who had tremor, dizziness, dysarthria, agitation, hallucinations and drowsiness during the first 24 hours

Sponsors and collaborators

Lead sponsor

Larissa University Hospital

Other

Registry information

Official study title

Intraoperative Use of Lidocaine and Postoperative Analgesia After Laparoscopic Cholecystectomy

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Aug 8, 2018
Registry last updated
Apr 5, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.