Knee ArthroscopyNCT00803725
Spinal Mepivicaine With Fentanyl for Outpatient Knee Arthroscopy
A study testing Mepivacaine without fentanyl and Mepivacaine with Fentanyl in people with Knee Arthroscopy, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The purpose of this study is to determine if the addition of intrathecal fentanyl to low dose mepivacaine spinal anesthesia provides adequate surgical anesthesia with shorter duration of motor blockade. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Knee Arthroscopy
- What is being tested?
- Mepivacaine without fentanyl and Mepivacaine with Fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2008to May 2009
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients having unilateral arthroscopic surgery of the knee;
- ASA I-III status;
- Age 18-80 years;
- BMI< 35.
Who cannot join
- Patients who have previous history of hypersensitivity to local anesthetics or contraindications for spinal anesthesia (i.e. bleeding diathesis, coagulopathy);
- Patients with radiating low back pain and neurological deficits in lower extremities;
- Patients who are incapable of giving an informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Spinal Mepivicaine With Fentanyl for Outpatient Knee Arthroscopy Surgery
The purpose of this study is to determine if the addition of intrathecal fentanyl to low dose mepivacaine spinal anesthesia provides adequate surgical anesthesia with shorter duration of motor blockade.
It is hypothesized that lower doses of spinal mepivacaine when combined with fentanyl will result in adequate surgical block for knee arthroscopy surgery with faster recovery and discharge compared to mepivacaine alone.
- Conditions
- Knee Arthroscopy
- Being tested
- Mepivacaine without fentanyl, Mepivacaine with Fentanyl
- Keywords
- spinal anesthesia, mepivacaine, fentanyl, duration of anesthesia, knee arthroscopy, regional anesthesia, Spinal anesthesia for knee arthroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mepivacaine without fentanylDrug
45 mg 1.5% mepivacaine injection for spinal anesthesia
Mepivacaine with FentanylDrug
10 micrograms fentanyl with 30 mg 1.5% mepivacaine injection for spinal anesthesia
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Mepivicaine for spinal anesthesia Receives: Drug: Mepivacaine without fentanyl |
| 2 | Experimental | Mepivacaine with Fentanyl for spinal anesthesia Receives: Drug: Mepivacaine with Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to complete motor block regression (0) as measured by modified Bromage scale.
Measured: Every 2 minutes from administration of the spinal until complete onset.
Secondary outcomes (1)
Block success, peak, and duration; time to ambulation, urination, discharge; incidence of adverse events.
Measured: Up to 72 hours after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2008 (estimated)
- Study startAug 2008
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee ArthroscopyStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00803725
- Sponsor's protocol ID
- 07-0683-A
- Status last verified
- Jan 2010
- First submitted
- 4 Dec 2008
- Last updated
- 26 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
O'Donnell D, Manickam B, Perlas A, Karkhanis R, Chan VW, Syed K, Brull R. Spinal mepivacaine with fentanyl for outpatient knee arthroscopy surgery: a randomized controlled trial. Can J Anaesth. 2010 Jan;57(1):32-8. doi: 10.1007/s12630-009-9207-6. Epub 2009 Oct 24.
PubMed 19856040
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Mepivicaine With Fentanyl for Outpatient Knee Arthroscopy Surgery
- ClinicalTrials.gov ID
- NCT00803725
- Acronym / sponsor ID
- 07-0683-A
- Conditions
- Knee Arthroscopy
- Keywords
- spinal anesthesia, mepivacaine, fentanyl, duration of anesthesia, knee arthroscopy, regional anesthesia, Spinal anesthesia for knee arthroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 5 Dec 2008 (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 if the addition of intrathecal fentanyl to low dose mepivacaine spinal anesthesia provides adequate surgical anesthesia with shorter duration of motor blockade.
It is hypothesized that lower doses of spinal mepivacaine when combined with fentanyl will result in adequate surgical block for knee arthroscopy surgery with faster recovery and discharge compared to mepivacaine alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Mepivacaine without fentanylMepivicaine for spinal anesthesia |
| 2 | Experimental | Drug: Mepivacaine with FentanylMepivacaine with Fentanyl for spinal anesthesia |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients having unilateral arthroscopic surgery of the knee;
- ASA I-III status;
- Age 18-80 years;
- BMI< 35.
Key exclusion criteria (3 listed)
- Patients who have previous history of hypersensitivity to local anesthetics or contraindications for spinal anesthesia (i.e. bleeding diathesis, coagulopathy);
- Patients with radiating low back pain and neurological deficits in lower extremities;
- Patients who are incapable of giving an informed consent.
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 without fentanyl45 mg 1.5% mepivacaine injection for spinal anesthesia | Drug | 1 |
| Mepivacaine with Fentanyl10 micrograms fentanyl with 30 mg 1.5% mepivacaine injection for spinal anesthesia | Drug | 2 |
Primary outcome
Time to complete motor block regression (0) as measured by modified Bromage scale.
Time frame: Every 2 minutes from administration of the spinal until complete onset.
1 secondary outcome
Block success, peak, and duration; time to ambulation, urination, discharge; incidence of adverse events.
Time frame: Up to 72 hours after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2010.
- Derived from this study: PubMed 19856040O'Donnell D, Manickam B, Perlas A, Karkhanis R, Chan VW, Syed K, Brull R. Spinal mepivacaine with fentanyl for outpatient knee arthroscopy surgery: a randomized controlled trial. Can J Anaesth. 2010 Jan;57(1):32-8. doi: 10.1007/s12630-009-9207-6. Epub 2009 Oct 24.
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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 without fentanyl and Mepivacaine with Fentanyl in people with Knee Arthroscopy, run by University Health Network, Toronto at 1 site in Canada.
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 4 inclusion and 3 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 26 Jan 2010. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 to complete motor block regression (0) as measured by modified Bromage scale. (time frame: Every 2 minutes from administration of the spinal until complete onset.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00803725, which also lists 1 linked publication.
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 26 Jan 2010.