Lidocaine and Analgesia After Laparoscopic Cholecystectomy

Not Applicable

Completed

• Conditions: Postoperative Pain; Opioid Consumption
• Interventions: Drug: Placebo; Drug: Lidocaine

• Registration Number: NCT03620591
• Lead Sponsor: 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

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 Timeline

• Study Start: 2018-07-02
• Study First Submitted: 2018-07-18
• Study First Submitted QC: 2018-08-06
• Study First Posted: 2018-08-08
• Primary Completion: 2022-01-31
• Study Completion: 2022-01-31
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-04
• Last Update Posted: 2022-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Intraoperative administration of normal saline to patients undergo laparoscopic cholecystectomy.
Lidocaine	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.

Primary Outcome Measures

Name	Time	Method
Postoperative opioid consumption	24 hours after the procedure	The total dose of tramadol is calculated as mg and administered intravenously.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital of Larissa; 🇬🇷 Larissa, Greece