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Clinical Trials/NCT03620591
NCT03620591
Completed
Not Applicable

Intraoperative Use of Lidocaine and Postoperative Analgesia After Laparoscopic Cholecystectomy

Larissa University Hospital1 site in 1 country98 target enrollmentJuly 2, 2018

Overview

Phase
Not Applicable
Intervention
Lidocaine
Conditions
Postoperative Pain
Sponsor
Larissa University Hospital
Enrollment
98
Locations
1
Primary Endpoint
Postoperative opioid consumption
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2, 2018
End Date
January 31, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Larissa University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Ioannis Baloyiannis

Assistant Professor of Surgery

Larissa University Hospital

Eligibility Criteria

Inclusion Criteria

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

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

Arms & Interventions

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.

Intervention: Lidocaine

Placebo

Intraoperative administration of normal saline to patients undergo laparoscopic cholecystectomy.

Intervention: Placebo

Outcomes

Primary Outcomes

Postoperative opioid consumption

Time Frame: 24 hours after the procedure

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

Secondary Outcomes

  • Change from Baseline Heart Rate(Intraoperative)
  • Incidence of shoulder pain(24 hours)
  • Change from baseline Mean Blood Pressure(Intraoperative)
  • Incidence of sedation and respiratory depression(24 hours)
  • Incidence of headache and dizziness(24 hours)
  • Change in depth of anesthesia(Intraoperative)
  • Incidence of Nausea and Vomiting(24 hours)
  • Postoperative pain(24 hrs after the procedure)
  • Side effect related to administration of lidocaine(24 hours)

Study Sites (1)

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