Lidocaine and Analgesia After Laparoscopic Cholecystectomy

NCT ID: NCT03620591

Last Updated: 2022-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-02

Study Completion Date

2022-01-31

Brief Summary

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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

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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.

Conditions

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Postoperative Pain Opioid Consumption

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Lidocaine

Intervention Type DRUG

Intraoperative administration of lidocaine

Placebo

Intraoperative administration of normal saline to patients undergo laparoscopic cholecystectomy.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Intraoperative administration of normal saline

Interventions

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Lidocaine

Intraoperative administration of lidocaine

Intervention Type DRUG

Placebo

Intraoperative administration of normal saline

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Larissa University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ioannis Baloyiannis

Assistant Professor of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ioannis Baloyiannis

Role: STUDY_DIRECTOR

University Hospital of Larissa

Chamaidi Sarakatsianou

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Larissa

Stavroula Georgopoulou

Role: STUDY_CHAIR

University Hospital of Larissa

Locations

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University Hospital of Larissa

Larissa, , Greece

Site Status

Countries

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Greece

Other Identifiers

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UHL27823/06/28/2018

Identifier Type: -

Identifier Source: org_study_id

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