Local Infiltration With Levobupivacaine During Laparoscopic Cholecystectomy

NCT ID: NCT04697329

Last Updated: 2022-05-27

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

PHASE4

Total Enrollment

233 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-03

Study Completion Date

2022-05-26

Brief Summary

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Randomized controlled trial on laparoscopic cholecystectomy. Interventional group: preincisional infiltration with levobupivacaine. Control group: no local infiltration.

Postoperative pain with numeric rating scale is registered, besides other parameters like heart rate, blood pressure, rescue analgesia requirements, nausea and vomiting, etc.

Detailed Description

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Conditions

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Laparoscopic Cholecystectomy Postoperative Pain Local Infiltration Levobupivacaine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Local infiltration

Group Type EXPERIMENTAL

Preincisional infiltration with levobupivacaine

Intervention Type DRUG

Local, preincisional infiltration of port sites with levobupivacaine 5 mg/ml 20 ml

No local infiltration

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Preincisional infiltration with levobupivacaine

Local, preincisional infiltration of port sites with levobupivacaine 5 mg/ml 20 ml

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Elective laparoscopic cholecystectomy

Exclusion Criteria

* Patient refusal
* Open surgery
* Reintervention surgery
* Drain tube placement
* Cognitive impairment
* Allergic reactions to local anesthetics
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitario de Móstoles

OTHER

Sponsor Role lead

Responsible Party

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JORGE HERRADOR BENITO

Principal Investigator. Surgeon.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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MANUEL DURÁN POVEDA, MD

Role: STUDY_DIRECTOR

H. U. REY JUAN CARLOS

GIL RODRÍGUEZ CARAVACA, MD

Role: STUDY_DIRECTOR

H. F. ALCORCÓN

Locations

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Hospital Universitario de Móstoles

Móstoles, Madrid, Spain

Site Status

Countries

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Spain

Other Identifiers

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HUMOSDEC2020

Identifier Type: -

Identifier Source: org_study_id

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