Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Lidocaine and Analgesia After Laparoscopic Cholecystectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03620591
Recruitment Status : Recruiting
First Posted : August 8, 2018
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
Ioannis Baloyiannis, Larissa University Hospital

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Postoperative Pain Opioid Consumption Drug: Lidocaine Drug: Placebo Not Applicable

Detailed Description:

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Intraoperative Use of Lidocaine and Postoperative Analgesia After Laparoscopic Cholecystectomy
Actual Study Start Date : July 2, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Lidocaine

Intraoperative administration of lidocaine to patients undergo laparoscopic cholecystectomy.

Prior induction to anesthesia, lidocaine bolus 1.5 mg / kg will be administered to the lidocaine group and then patients will be connected to a continuous 2 mg / kg / h administration of lidocaine until the end of the procedure.

Drug: Lidocaine
Intraoperative administration of lidocaine

Placebo Comparator: Placebo
Intraoperative administration of normal saline to patients undergo laparoscopic cholecystectomy.
Drug: Placebo
Intraoperative administration of normal saline




Primary Outcome Measures :
  1. Postoperative opioid consumption [ Time Frame: 24 hours after the procedure ]
    The total dose of tramadol is calculated as mg and administered intravenously.


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03620591


Contacts
Layout table for location contacts
Contact: Ioannis Baloyiannis +306979339461 balioan@hotmail.com

Locations
Layout table for location information
Greece
University Hospital of Larissa Recruiting
Larissa, Greece, 41110
Contact: Ioannis Baloyiannis    +306979339461    balioan@hotmail.com   
Sub-Investigator: Konstantinos Perivoliotis         
Sub-Investigator: George Tzovaras         
Sponsors and Collaborators
Larissa University Hospital
Investigators
Layout table for investigator information
Study Director: Ioannis Baloyiannis University Hospital of Larissa
Principal Investigator: Chamaidi Sarakatsianou University Hospital of Larissa
Study Chair: Stavroula Georgopoulou University Hospital of Larissa

Layout table for additonal information
Responsible Party: Ioannis Baloyiannis, Assistant Professor of Surgery, Larissa University Hospital
ClinicalTrials.gov Identifier: NCT03620591     History of Changes
Other Study ID Numbers: UHL27823/06/28/2018
First Posted: August 8, 2018    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: December 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ioannis Baloyiannis, Larissa University Hospital:
Lidocaine
Postoperative Pain
Opioid consumption
Laparoscopic cholecystectomy

Additional relevant MeSH terms:
Layout table for MeSH terms
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action