Lidocaine and Analgesia After Laparoscopic Cholecystectomy

Postoperative Pain Clinical Trial

Official title:

Intraoperative Use of Lidocaine and Postoperative Analgesia After Laparoscopic Cholecystectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03620591
• Other study ID #: UHL27823/06/28/2018
• Status: Completed
• Phase: N/A
• Start date: July 2, 2018
• Est. completion date: January 31, 2022

Study information

• Verified date: April 2022
• Source: Larissa University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid Consumption
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Lidocaine
Intraoperative administration of lidocaine
• Placebo
Intraoperative administration of normal saline

Locations

Country	Name	City	State
Greece	University Hospital of Larissa	Larissa

Sponsors (1)

Lead Sponsor	Collaborator
Larissa University Hospital

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative opioid consumption	The total dose of tramadol is calculated as mg and administered intravenously.	24 hours after the procedure
Secondary	Postoperative pain	Numeric Rate scale 0-10 (0=no pain to 10=worst imaginable pain)	Departure of the patient from the recovery room (0hrs)
Secondary	Postoperative pain	Numeric Rate scale 0-10 (0=no pain to 10=worst imaginable pain)	6 hrs after the procedure
Secondary	Postoperative pain	Numeric Rate scale 0-10 (0=no pain to 10=worst imaginable pain)	12 hrs after the procedure
Secondary	Postoperative pain	Numeric Rate scale 0-10 (0=no pain to 10=worst imaginable pain)	24 hrs after the procedure
Secondary	Incidence of Nausea and Vomiting	The percentage of patients who had nausea and vomiting during the first 24 hours	24 hours
Secondary	Incidence of sedation and respiratory depression	The percentage of patients who had sedation and respiratory depression during the first 24 hours	24 hours
Secondary	Incidence of shoulder pain	The percentage of patients who had shoulder pain during the first24 hours	24 hours
Secondary	Incidence of headache and dizziness	The percentage of patients who had headache and dizziness during the first 24 hours	24 hours
Secondary	Change from baseline Mean Blood Pressure	Non-invasive blood pressure measurement by using sphygmomanometer cuff	Intraoperative
Secondary	Change from Baseline Heart Rate	Bradycardia, tachycardia during the procedure	Intraoperative
Secondary	Change in depth of anesthesia	Maintenance of Bispectral index (BIS) values of 40 to 50	Intraoperative
Secondary	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