Opioid Free AnaesthesiaPhase 3NCT02150161
Opioid vs. Opioid-free Anesthesia for Hip Arthroscopy
A Phase 3 study testing Lidocaine/ ketamine and Fentanyl in people with Opioid Free Anaesthesia and Postoperative Analgesia, run by Clinica Santa Maria at 1 site in Chile.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opioid Free Anaesthesia, Postoperative Analgesia
- What is being tested?
- Lidocaine/ ketamine and Fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteChile
- Study dates
- May 2014to Aug 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years old
- ASA I-II
- Undergoing elective hip arthroscopy
Who cannot join
- Known allergies to study drugs
- Opioid use 1 month prior to surgery
- BMI >30
- Unable to comprehend visual analog scale
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Opioid Free Anaesthesia, Postoperative Analgesia
- Being tested
- Lidocaine/ ketamine, Fentanyl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine/ ketamineDrug
FentanylDrug
| Study group | Role | What they receive |
|---|---|---|
| lidocaine/ ketamine infusion | Experimental | 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 Receives: Drug: Lidocaine/ ketamine |
| fentanyl | Active comparator | iv fentanyl, 3ug/kg bolus Receives: Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative nausea and vomiting in the recovery room
Measured: first 3 postoperative hours
morphine consumption in the recovery room
Measured: first 3 postopeartive hours
Secondary outcomes (2)
Incidence of postoperative nausea and vomiting on day 1
Measured: 1st postoperative day
Anesthestic gas consumption
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study startMay 2014
- Primary completionAug 2015
- Study completionAug 2015
Why it stopped: DSMB estimated futility of the trial and safety risk
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Free AnaesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Santa Maria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Torres, Clinica Santa Maria
- Investigators
- David Torres, MD; MSc, Principal investigator, Clinica Santa Maria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02150161
- Sponsor's protocol ID
- 56csm2014001
- Status last verified
- Sep 2015
- First submitted
- 26 May 2014
- Last updated
- 25 Sep 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fentanyl vs. Lidocaine/Ketamine Infusion for Hip Arthroscopy
- ClinicalTrials.gov ID
- NCT02150161
- Acronym / sponsor ID
- 56csm2014001
- Conditions
- Opioid Free Anaesthesia, Postoperative Analgesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: DSMB estimated futility of the trial and safety risk
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Clinica Santa MariaUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 29 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lidocaine/ ketamine infusion | Experimental | Drug: Lidocaine/ ketaminelidocaine 1mg/Kg bolus, followed by continuous infusion 1 mg/kg/h AND ketamine 1mg/Kg bolus followed by continuous infusion 1 mg/kg/h |
| fentanyl | Active comparator | Drug: Fentanyliv fentanyl, 3ug/kg bolus |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-65 years old
- ASA I-II
- Undergoing elective hip arthroscopy
Key exclusion criteria (4 listed)
- Known allergies to study drugs
- Opioid use 1 month prior to surgery
- BMI >30
- Unable to comprehend visual analog scale
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine/ ketamine | Drug | lidocaine/ ketamine infusion |
| Fentanyl | Drug | fentanyl |
Primary outcome
Incidence of postoperative nausea and vomiting in the recovery room
Time frame: first 3 postoperative hours
morphine consumption in the recovery room
Time frame: first 3 postopeartive hours
2 secondary outcomes
Incidence of postoperative nausea and vomiting on day 1
Time frame: 1st postoperative day
Anesthestic gas consumption
Time frame: intraoperative
Results and safety
The study was stopped early (reason given: DSMB estimated futility of the trial and safety risk). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Torres, MD; MSc principal investigator
Clinica Santa Maria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lidocaine/ ketamine and Fentanyl in people with Opioid Free Anaesthesia and Postoperative Analgesia, run by Clinica Santa Maria at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: DSMB estimated futility of the trial and safety risk). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative nausea and vomiting in the recovery room (time frame: first 3 postoperative hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2015.