Lidocaine and Analgesia After Laparoscopic Cholecystectomy

Intraoperative Use of Lidocaine and Postoperative 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

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Opioid Consumption
• Intervention / Treatment: Drug: Lidocaine; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Larissa, Greece, 41110
    • University Hospital Of Larissa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative opioid consumption	The total dose of tramadol is calculated as mg and administered intravenously.	24 hours after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain	Numeric Rate scale 0-10 (0=no pain to 10=worst imaginable pain)	Departure of the patient from the recovery room (0hrs)
Postoperative pain	Numeric Rate scale 0-10 (0=no pain to 10=worst imaginable pain)	6 hrs after the procedure
Postoperative pain	Numeric Rate scale 0-10 (0=no pain to 10=worst imaginable pain)	12 hrs after the procedure
Postoperative pain	Numeric Rate scale 0-10 (0=no pain to 10=worst imaginable pain)	24 hrs after the procedure
Incidence of Nausea and Vomiting	The percentage of patients who had nausea and vomiting during the first 24 hours	24 hours
Incidence of sedation and respiratory depression	The percentage of patients who had sedation and respiratory depression during the first 24 hours	24 hours
Incidence of shoulder pain	The percentage of patients who had shoulder pain during the first24 hours	24 hours
Incidence of headache and dizziness	The percentage of patients who had headache and dizziness during the first 24 hours	24 hours
Change from baseline Mean Blood Pressure	Non-invasive blood pressure measurement by using sphygmomanometer cuff	Intraoperative
Change from Baseline Heart Rate	Bradycardia, tachycardia during the procedure	Intraoperative
Change in depth of anesthesia	Maintenance of Bispectral index (BIS) values of 40 to 50	Intraoperative
Side effect related to administration of lidocaine	The percentage of patients who had tremor, dizziness, dysarthria, agitation, hallucinations and drowsiness during the first 24 hours	24 hours

Collaborators and Investigators

• Sponsor: Larissa University Hospital
• Investigators: Study Director: Ioannis Baloyiannis, University Hospital Of Larissa; Principal Investigator: Chamaidi Sarakatsianou, University Hospital Of Larissa; Study Chair: Stavroula Georgopoulou, University Hospital Of Larissa

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2018
• Primary Completion (Actual): January 31, 2022
• Study Completion (Actual): January 31, 2022

Study Registration Dates

• First Submitted: July 18, 2018
• First Submitted That Met QC Criteria: August 6, 2018
• First Posted (Actual): August 8, 2018

Study Record Updates

• Last Update Posted (Actual): April 5, 2022
• Last Update Submitted That Met QC Criteria: April 4, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Postoperative Pain; Lidocaine; Laparoscopic cholecystectomy; Opioid consumption
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: UHL27823/06/28/2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No