Opioid vs. Opioid-free Anesthesia for Hip Arthroscopy

NCT ID: NCT02150161

Last Updated: 2015-09-25

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

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2015-08-31

Brief Summary

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The purpose of this study is to determine whether an infusion of lidocaine/ketamine compared to fentanyl is equivalent in anesthesia effectiveness and can help reduce the incidence of postoperative nausea and vomiting in patients undergoing elective hip arthroscopy surgery.

Detailed Description

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Conditions

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Opioid Free Anaesthesia Postoperative Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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lidocaine/ ketamine infusion

lidocaine 1mg/Kg bolus, followed by continuous infusion 1 mg/kg/h AND ketamine 1mg/Kg bolus followed by continuous infusion 1 mg/kg/h

Group Type EXPERIMENTAL

Lidocaine/ ketamine

Intervention Type DRUG

fentanyl

iv fentanyl, 3ug/kg bolus

Group Type ACTIVE_COMPARATOR

Fentanyl

Intervention Type DRUG

Interventions

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Lidocaine/ ketamine

Intervention Type DRUG

Fentanyl

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 18-65 years old
* ASA I-II
* Undergoing elective hip arthroscopy

Exclusion Criteria

* Known allergies to study drugs
* Opioid use 1 month prior to surgery
* BMI \>30
* Unable to comprehend visual analog scale
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinica Santa Maria

OTHER

Sponsor Role lead

Responsible Party

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David Torres

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Torres, MD; MSc

Role: PRINCIPAL_INVESTIGATOR

Clinica Santa Maria

Locations

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Clinica Santa Maria

Santiago, , Chile

Site Status

Countries

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Chile

Other Identifiers

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56csm2014001

Identifier Type: -

Identifier Source: org_study_id

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