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Lidocaine and Analgesia After Laparoscopic Cholecystectomy

Primary Purpose

Postoperative Pain, Opioid Consumption

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Lidocaine
Placebo
Sponsored by
Larissa University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Pain focused on measuring Lidocaine, Postoperative Pain, Opioid consumption, Laparoscopic cholecystectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital of Larissa

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Lidocaine

Placebo

Arm Description

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.

Intraoperative administration of normal saline to patients undergo laparoscopic cholecystectomy.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Postoperative pain
Numeric Rate scale 0-10 (0=no pain to 10=worst imaginable pain)
Postoperative pain
Numeric Rate scale 0-10 (0=no pain to 10=worst imaginable pain)
Postoperative pain
Numeric Rate scale 0-10 (0=no pain to 10=worst imaginable pain)
Postoperative pain
Numeric Rate scale 0-10 (0=no pain to 10=worst imaginable pain)
Incidence of Nausea and Vomiting
The percentage of patients who had nausea and vomiting during the first 24 hours
Incidence of sedation and respiratory depression
The percentage of patients who had sedation and respiratory depression during the first 24 hours
Incidence of shoulder pain
The percentage of patients who had shoulder pain during the first24 hours
Incidence of headache and dizziness
The percentage of patients who had headache and dizziness during the first 24 hours
Change from baseline Mean Blood Pressure
Non-invasive blood pressure measurement by using sphygmomanometer cuff
Change from Baseline Heart Rate
Bradycardia, tachycardia during the procedure
Change in depth of anesthesia
Maintenance of Bispectral index (BIS) values of 40 to 50
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

Full Information

First Posted
July 18, 2018
Last Updated
April 4, 2022
Sponsor
Larissa University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03620591
Brief Title
Lidocaine and Analgesia After Laparoscopic Cholecystectomy
Official Title
Intraoperative Use of Lidocaine and Postoperative Analgesia After Laparoscopic Cholecystectomy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
July 2, 2018 (Actual)
Primary Completion Date
January 31, 2022 (Actual)
Study Completion Date
January 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Larissa University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Opioid Consumption
Keywords
Lidocaine, Postoperative Pain, Opioid consumption, Laparoscopic cholecystectomy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lidocaine
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Intraoperative administration of normal saline to patients undergo laparoscopic cholecystectomy.
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
Intraoperative administration of lidocaine
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Intraoperative administration of normal saline
Primary Outcome Measure Information:
Title
Postoperative opioid consumption
Description
The total dose of tramadol is calculated as mg and administered intravenously.
Time Frame
24 hours after the procedure
Secondary Outcome Measure Information:
Title
Postoperative pain
Description
Numeric Rate scale 0-10 (0=no pain to 10=worst imaginable pain)
Time Frame
Departure of the patient from the recovery room (0hrs)
Title
Postoperative pain
Description
Numeric Rate scale 0-10 (0=no pain to 10=worst imaginable pain)
Time Frame
6 hrs after the procedure
Title
Postoperative pain
Description
Numeric Rate scale 0-10 (0=no pain to 10=worst imaginable pain)
Time Frame
12 hrs after the procedure
Title
Postoperative pain
Description
Numeric Rate scale 0-10 (0=no pain to 10=worst imaginable pain)
Time Frame
24 hrs after the procedure
Title
Incidence of Nausea and Vomiting
Description
The percentage of patients who had nausea and vomiting during the first 24 hours
Time Frame
24 hours
Title
Incidence of sedation and respiratory depression
Description
The percentage of patients who had sedation and respiratory depression during the first 24 hours
Time Frame
24 hours
Title
Incidence of shoulder pain
Description
The percentage of patients who had shoulder pain during the first24 hours
Time Frame
24 hours
Title
Incidence of headache and dizziness
Description
The percentage of patients who had headache and dizziness during the first 24 hours
Time Frame
24 hours
Title
Change from baseline Mean Blood Pressure
Description
Non-invasive blood pressure measurement by using sphygmomanometer cuff
Time Frame
Intraoperative
Title
Change from Baseline Heart Rate
Description
Bradycardia, tachycardia during the procedure
Time Frame
Intraoperative
Title
Change in depth of anesthesia
Description
Maintenance of Bispectral index (BIS) values of 40 to 50
Time Frame
Intraoperative
Title
Side effect related to administration of lidocaine
Description
The percentage of patients who had tremor, dizziness, dysarthria, agitation, hallucinations and drowsiness during the first 24 hours
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ioannis Baloyiannis
Organizational Affiliation
University Hospital of Larissa
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Chamaidi Sarakatsianou
Organizational Affiliation
University Hospital of Larissa
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stavroula Georgopoulou
Organizational Affiliation
University Hospital of Larissa
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital of Larissa
City
Larissa
ZIP/Postal Code
41110
Country
Greece

12. IPD Sharing Statement

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Lidocaine and Analgesia After Laparoscopic Cholecystectomy

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