NCT03620591

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable postoperative-pain

Timeline
Completed

Started Jul 2018

Longer than P75 for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 2, 2018

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

July 18, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 8, 2018

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

April 5, 2022

Status Verified

April 1, 2022

Enrollment Period

3.6 years

First QC Date

July 18, 2018

Last Update Submit

April 4, 2022

Conditions

Postoperative PainOpioid Consumption

Keywords

LidocainePostoperative PainOpioid consumptionLaparoscopic cholecystectomy

Outcome Measures

Primary Outcomes (1)

  • Postoperative opioid consumption

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

    24 hours after the procedure

Secondary Outcomes (12)

  • Postoperative pain

    Departure of the patient from the recovery room (0hrs)

  • Postoperative pain

    6 hrs after the procedure

  • Postoperative pain

    12 hrs after the procedure

  • Postoperative pain

    24 hrs after the procedure

  • Incidence of Nausea and Vomiting

    24 hours

  • +7 more secondary outcomes

Study Arms (2)

Lidocaine

ACTIVE COMPARATOR

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.

Drug: Lidocaine

Placebo

PLACEBO COMPARATOR

Intraoperative administration of normal saline to patients undergo laparoscopic cholecystectomy.

Drug: Placebo

Interventions

LidocaineDRUG

Intraoperative administration of lidocaine

Lidocaine
PlaceboDRUG

Intraoperative administration of normal saline

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA physical status I-II
  • Age ≥ 18 years old
  • BMI ≤ 35

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Larissa

Larissa, 41110, Greece

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Ioannis Baloyiannis

    University Hospital of Larissa

    STUDY DIRECTOR

  • Chamaidi Sarakatsianou

    University Hospital of Larissa

    PRINCIPAL INVESTIGATOR

  • Stavroula Georgopoulou

    University Hospital of Larissa

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Surgery

Study Record Dates

First Submitted

July 18, 2018

First Posted

August 8, 2018

Study Start

July 2, 2018

Primary Completion

January 31, 2022

Study Completion

January 31, 2022

Last Updated

April 5, 2022

Record last verified: 2022-04

Locations

GR(1)