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NCT02150161 Clinical Trial

Opioid vs. Opioid-free Anesthesia for Hip Arthroscopy

Postoperative Analgesia Clinical Trial

Official title:
Fentanyl vs. Lidocaine/Ketamine Infusion for Hip Arthroscopy

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02150161
Other study ID # 56csm2014001
Secondary ID
Status Terminated
Phase Phase 3
First received May 26, 2014
Last updated September 24, 2015
Start date May 2014
Est. completion date August 2015

Study information
Verified date September 2015
Source Clinica Santa Maria
Contact n/a
Is FDA regulated No
Health authority Chile: Servicio de Salud Metropolitano Oriente
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Terminated
Enrollment 53
Est. completion date August 2015
Est. primary completion date August 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Lidocaine/ ketamine

• Fentanyl

Locations
Country Name City State
Chile Clinica Santa Maria Santiago

Sponsors (1)
Lead Sponsor Collaborator
Clinica Santa Maria

Country where clinical trial is conducted

Chile, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of postoperative nausea and vomiting in the recovery room first 3 postoperative hours Yes
Primary morphine consumption in the recovery room first 3 postopeartive hours No
Secondary Incidence of postoperative nausea and vomiting on day 1 1st postoperative day Yes
Secondary Anesthestic gas consumption intraoperative No
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