Arthroscopic Knee SurgeryNCT01701102
Study to Find Optimal Dose of Local Spinal Anesthetic (Mepivacaine) Combined With Narcotic (Fentanyl) For Knee Surgery
A study testing Mepivacaine (24 mg) plus fentanyl, Mepivacaine (27 mg) plus fentanyl and Mepivacaine (30 mg) plus fentanyl in people with Arthroscopic Knee Surgery, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial summary
Prolonged motor block and delayed ability to walk are limitations of spinal anesthesia in ambulatory (same-day) surgery. This can be improved by lowering the dose of local anesthetic (a medication that, when injected around nerves, blocks nerve conduction, resulting in numbness and weakness) used in the spine, but too… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Arthroscopic Knee Surgery
- What is being tested?
- Mepivacaine (24 mg) plus fentanyl, Mepivacaine (27 mg) plus fentanyl and Mepivacaine (30 mg) plus fentanyl
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Dec 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects aged 18-60
- Patients scheduled for "simple" knee arthroscopies, including meniscectomy, debridement, and plica.
Who cannot join
- Subjects aged <18 or >60
- Subjects greater than 190 cm in height
- Patients scheduled for ligament reconstruction or surgery involving bone
- Daily use of narcotics for greater than one week pre-op
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
Official title: Optimal Dose of Spinal Mepivacaine Combined With Fentanyl For Knee Arthroscopy
Prolonged motor block and delayed ability to walk are limitations of spinal anesthesia in ambulatory (same-day) surgery. This can be improved by lowering the dose of local anesthetic (a medication that, when injected around nerves, blocks nerve conduction, resulting in numbness and weakness) used in the spine, but too low a dose can result in an incomplete block (inadequate anesthesia) in some patients. There is evidence that adding a low dose of fentanyl, a narcotic, to mepivacaine enhances the anesthetic effect. The purpose of this study is to determine the lowest dose of mepivacaine, a local anesthetic, when combined with fentanyl, for which spinal anesthesia is adequate for ambulatory knee arthroscopy.
- Conditions
- Arthroscopic Knee Surgery
- Being tested
- Mepivacaine (24 mg) plus fentanyl, Mepivacaine (27 mg) plus fentanyl, Mepivacaine (30 mg) plus fentanyl, Mepivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mepivacaine (24 mg) plus fentanylProcedure or surgery
Mepivacaine (24 mg) and fentanyl (10 µg)
Mepivacaine (27 mg) plus fentanylProcedure or surgery
Mepivacaine (27 mg) and fentanyl (10 µg)
Mepivacaine (30 mg) plus fentanylProcedure or surgery
Mepivacaine (30 mg) and fentanyl (10 µg)
MepivacaineProcedure or surgery
Mepivacaine 37.5 mg
| Study group | Role | What they receive |
|---|---|---|
| Mepivacaine 37.5 mg | Active comparator | Not described Receives: Procedure: Mepivacaine |
| Mepivacaine 30 mg plus fentanyl 10 µg | Active comparator | Not described Receives: Procedure: Mepivacaine (30 mg) plus fentanyl |
| Mepivacaine 27 mg plus fentanyl 10 µg | Active comparator | Not described Receives: Procedure: Mepivacaine (27 mg) plus fentanyl |
| Mepivacaine 24 mg plus fentanyl 10 µg | Active comparator | Not described Receives: Procedure: Mepivacaine (24 mg) plus fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time From Spinal Administration to Block Regression to the S1 Dermatome in Post-Anesthesia Care Unit (PACU)
The time frame of the study for each patient only covers the period between time of surgery and time of discharge from the hospital, which is on the same day as the day of surgery
Measured: Participants will be followed for the duration of their recovery after surgery in the post-anesthesia care unit (PACU), an expected average of 2-4 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2012 (estimated)
- Study startDec 2011
- Primary completionJul 2012
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Arthroscopic Knee SurgeryStudies of the same condition, open and under way.
- More trials run by Hospital for Special Surgery, New YorkThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01701102
- Sponsor's protocol ID
- 11140
- Status last verified
- Mar 2016
- First submitted
- 4 Jan 2012
- Last updated
- 5 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Dose of Spinal Mepivacaine Combined With Fentanyl For Knee Arthroscopy
- ClinicalTrials.gov ID
- NCT01701102
- Acronym / sponsor ID
- 11140
- Conditions
- Arthroscopic Knee Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 4 Oct 2012 (estimated)
- Results
- Posted 10 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prolonged motor block and delayed ability to walk are limitations of spinal anesthesia in ambulatory (same-day) surgery. This can be improved by lowering the dose of local anesthetic (a medication that, when injected around nerves, blocks nerve conduction, resulting in numbness and weakness) used in the spine, but too low a dose can result in an incomplete block (inadequate anesthesia) in some patients. There is evidence that adding a low dose of fentanyl, a narcotic, to mepivacaine enhances the anesthetic effect. The purpose of this study is to determine the lowest dose of mepivacaine, a local anesthetic, when combined with fentanyl, for which spinal anesthesia is adequate for ambulatory knee arthroscopy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mepivacaine 37.5 mg | Active comparator | Procedure: Mepivacaine |
| Mepivacaine 30 mg plus fentanyl 10 µg | Active comparator | Procedure: Mepivacaine (30 mg) plus fentanyl |
| Mepivacaine 27 mg plus fentanyl 10 µg | Active comparator | Procedure: Mepivacaine (27 mg) plus fentanyl |
| Mepivacaine 24 mg plus fentanyl 10 µg | Active comparator | Procedure: Mepivacaine (24 mg) plus fentanyl |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Subjects aged 18-60
- Patients scheduled for "simple" knee arthroscopies, including meniscectomy, debridement, and plica.
Key exclusion criteria (4 listed)
- Subjects aged <18 or >60
- Subjects greater than 190 cm in height
- Patients scheduled for ligament reconstruction or surgery involving bone
- Daily use of narcotics for greater than one week pre-op
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 |
|---|---|---|
| Mepivacaine (24 mg) plus fentanylMepivacaine (24 mg) and fentanyl (10 µg) | Procedure or surgery | Mepivacaine 24 mg plus fentanyl 10 µg |
| Mepivacaine (27 mg) plus fentanylMepivacaine (27 mg) and fentanyl (10 µg) | Procedure or surgery | Mepivacaine 27 mg plus fentanyl 10 µg |
| Mepivacaine (30 mg) plus fentanylMepivacaine (30 mg) and fentanyl (10 µg) | Procedure or surgery | Mepivacaine 30 mg plus fentanyl 10 µg |
| MepivacaineMepivacaine 37.5 mg | Procedure or surgery | Mepivacaine 37.5 mg |
Primary outcome
Time From Spinal Administration to Block Regression to the S1 Dermatome in Post-Anesthesia Care Unit (PACU)
Time frame: Participants will be followed for the duration of their recovery after surgery in the post-anesthesia care unit (PACU), an expected average of 2-4 hours.
The time frame of the study for each patient only covers the period between time of surgery and time of discharge from the hospital, which is on the same day as the day of surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mepivacaine (24 mg) plus fentanyl, Mepivacaine (27 mg) plus fentanyl and Mepivacaine (30 mg) plus fentanyl in people with Arthroscopic Knee Surgery, run by Hospital for Special Surgery, New York at 1 site in United States.
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 2 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: finished, as of the sponsor's last update on 5 Apr 2016. 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 United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time From Spinal Administration to Block Regression to the S1 Dermatome in Post-Anesthesia Care Unit (PACU) (time frame: Participants will be followed for the duration of their recovery after surgery in the post-anesthesia care unit (PACU), an expected average of 2-4 hours.). 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 5 Apr 2016.