Opioid vs. Opioid-free Anesthesia for Hip Arthroscopy

Fentanyl vs. Lidocaine/Ketamine Infusion for Hip Arthroscopy

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.

Study Overview

• Status: Terminated
• Conditions: Postoperative Analgesia; Opioid Free Anaesthesia
• Intervention / Treatment: Drug: Fentanyl; Drug: Lidocaine/ ketamine

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Phase 3

Contacts and Locations

Study Locations

• Chile
  • Santiago, Chile
    • Clínica Santa María

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: Lidocaine/ ketamine
Active Comparator: fentanyl; iv fentanyl, 3ug/kg bolus	Drug: Fentanyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of postoperative nausea and vomiting in the recovery room	first 3 postoperative hours
morphine consumption in the recovery room	first 3 postopeartive hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of postoperative nausea and vomiting on day 1	1st postoperative day
Anesthestic gas consumption	intraoperative

Collaborators and Investigators

• Sponsor: Clinica Santa Maria
• Investigators: Principal Investigator: David Torres, MD; MSc, Clínica Santa María

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: May 26, 2014
• First Submitted That Met QC Criteria: May 28, 2014
• First Posted (Estimate): May 29, 2014

Study Record Updates

• Last Update Posted (Estimate): September 25, 2015
• Last Update Submitted That Met QC Criteria: September 24, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Analgesics, Opioid; Narcotics; Membrane Transport Modulators; Adjuvants, Anesthesia; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Ketamine; Fentanyl; Lidocaine
• Other Study ID Numbers: 56csm2014001