Spinal AnesthesiaNCT00537472
Low Dose Spinal Bupivacaine for Total Knee Replacement and Recovery Room Wait Time
A study testing Low dose bupivicaine in spinal anesthetic and Standard dose bupivacaine in spinal anesthetic in people with Spinal Anesthesia and Total Knee Arthroplasty, run by Queen's University at 1 site in Canada.
Trial summary
This study plans to investigate whether a reduced dose of bupivacaine (a local anesthetic numbing drug) injected into the spinal space for a total knee replacement will result in a shorter time to discharge from the recovery room while maintaining adequate surgical anesthesia. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spinal Anesthesia, Total Knee Arthroplasty
- What is being tested?
- Low dose bupivicaine in spinal anesthetic and Standard dose bupivacaine in spinal anesthetic
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2007to Dec 2008
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing elective one-sided total knee replacement for osteoarthritis at our institution where spinal anesthesia has been chosen by the patient and the anesthetist
Who cannot join
- Contraindications to spinal anesthesia (such as increase pressure in brain, bleeding disorder, serious valvular heart disease, serious infection in the blood or on your lower back, certain neurological disorders such as multiple sclerosis, desire for a general anesthetic)
- Allergies to local anesthetics, morphine or fentanyl
- Both knees being done at same surgery
- Revision of a previous knee replacement
- Knee replacement for reasons other than osteoarthritis (such as rheumatoid arthritis)
- Potential for difficult intubation in case of need for general anesthetic
Show all 9Show fewer
- Patients under 150 cm or over 200 cm
- BMI greater than 40
- Lack of patient consent or patient refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Low Dose Spinal Bupivacaine for Total Knee Arthroplasty and Recovery Room Wait Time
This study plans to investigate whether a reduced dose of bupivacaine (a local anesthetic numbing drug) injected into the spinal space for a total knee replacement will result in a shorter time to discharge from the recovery room while maintaining adequate surgical anesthesia.
Read the detailed description
With the doses of bupivacaine currently being used in spinal anesthetics at our institution, patients' sensory blocks are often much higher than needed to achieve adequate surgical anesthesia. This translates into a prolonged waiting period in the recovery room before the level regresses down to the pre-existing standard for discharge to the ward, as well as the pre-existing level before a post-operative nerve block for extended pain relief can be performed. This prolonged period in the recovery room leads to general delays in operating room usage and thus surgical cancellations. The excessive drug doses currently used also put patients at risk for increasing side effects including low blood pressure, slow heart rates, and nausea and vomiting.
By using a reduced dose of bupivacaine in a spinal anesthetic for a one sided knee replacement, we hope to significantly reduce the recovery room waiting times until the criteria for recovery room discharge or completion of a post-operative nerve block are met, while still providing adequate surgical anesthesia.
Patients will receive either 9 mg (intervention dose) or 13 mg (control dose) of bupivacaine through a spinal injection. Once the patients enter the recovery room after surgery the level of their sensory block will be tested as per usual protocol by the recovery room nurses every 15 minutes until a predefined level has been reached, and the two groups will be compared.
- Conditions
- Spinal Anesthesia, Total Knee Arthroplasty
- Being tested
- Low dose bupivicaine in spinal anesthetic, Standard dose bupivacaine in spinal anesthetic
- Keywords
- Bupivacaine, spinal anesthesia, total knee arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose bupivicaine in spinal anestheticDrug
Bupivacaine 9 mg intrathecal single shot injection at start of surgery
Standard dose bupivacaine in spinal anestheticDrug
Bupivacaine 13 mg intrathecal single shot injection at start of surgery
| Study group | Role | What they receive |
|---|---|---|
| I | Experimental | Not described Receives: Drug: Low dose bupivicaine in spinal anesthetic |
| II | Active comparator | Not described Receives: Drug: Standard dose bupivacaine in spinal anesthetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from spinal injection of bupivicaine until recovery room discharge criteria met.
Measured: Until recovery room discharge post surgery
Secondary outcomes (3)
Need for pharmacologic rescue from inadequate spinal block during the procedure.
Measured: Until end of surgery
Time from entrance into recovery room until criteria for a recovery room discharge are met
Measured: Until recovery room discharge criteria are met
Time from entrance into recovery room until criteria for a femoral nerve block for post-operative pain control are met
Measured: Until criteria are met for post operative nerve block in recovery room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal AnesthesiaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Investigators
- Melanie Jaeger, MD, FRCPSC, Principal investigator, Staff anesthesiologist at Kingston General HospitalDale Engen, MD, FRCPSC, Study director, Staff anesthesiologist at Kingston General HospitalDevin Sydor, MD, Study director, Anesthesiology resident at Kingston General Hospital/Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00537472
- Sponsor's protocol ID
- 6106
- Status last verified
- Apr 2009
- First submitted
- 28 Sep 2007
- Last updated
- 17 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dose Spinal Bupivacaine for Total Knee Arthroplasty and Recovery Room Wait Time
- ClinicalTrials.gov ID
- NCT00537472
- Acronym / sponsor ID
- 6106
- Conditions
- Spinal Anesthesia, Total Knee Arthroplasty
- Keywords
- Bupivacaine, spinal anesthesia, total knee arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 1 Oct 2007 (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.
This study plans to investigate whether a reduced dose of bupivacaine (a local anesthetic numbing drug) injected into the spinal space for a total knee replacement will result in a shorter time to discharge from the recovery room while maintaining adequate surgical anesthesia.
Detailed description
With the doses of bupivacaine currently being used in spinal anesthetics at our institution, patients' sensory blocks are often much higher than needed to achieve adequate surgical anesthesia. This translates into a prolonged waiting period in the recovery room before the level regresses down to the pre-existing standard for discharge to the ward, as well as the pre-existing level before a post-operative nerve block for extended pain relief can be performed. This prolonged period in the recovery room leads to general delays in operating room usage and thus surgical cancellations. The excessive drug doses currently used also put patients at risk for increasing side effects including low blood pressure, slow heart rates, and nausea and vomiting.
By using a reduced dose of bupivacaine in a spinal anesthetic for a one sided knee replacement, we hope to significantly reduce the recovery room waiting times until the criteria for recovery room discharge or completion of a post-operative nerve block are met, while still providing adequate surgical anesthesia.
Patients will receive either 9 mg (intervention dose) or 13 mg (control dose) of bupivacaine through a spinal injection. Once the patients enter the recovery room after surgery the level of their sensory block will be tested as per usual protocol by the recovery room nurses every 15 minutes until a predefined level has been reached, and the two groups will be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Drug: Low dose bupivicaine in spinal anesthetic |
| II | Active comparator | Drug: Standard dose bupivacaine in spinal anesthetic |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing elective one-sided total knee replacement for osteoarthritis at our institution where spinal anesthesia has been chosen by the patient and the anesthetist
Key exclusion criteria (9 listed)
- Contraindications to spinal anesthesia (such as increase pressure in brain, bleeding disorder, serious valvular heart disease, serious infection in the blood or on your lower back, certain neurological disorders such as multiple sclerosis, desire for a general anesthetic)
- Allergies to local anesthetics, morphine or fentanyl
- Both knees being done at same surgery
- Revision of a previous knee replacement
- Knee replacement for reasons other than osteoarthritis (such as rheumatoid arthritis)
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 |
|---|---|---|
| Low dose bupivicaine in spinal anestheticBupivacaine 9 mg intrathecal single shot injection at start of surgery | Drug | I |
| Standard dose bupivacaine in spinal anestheticBupivacaine 13 mg intrathecal single shot injection at start of surgery | Drug | II |
Primary outcome
Time from spinal injection of bupivicaine until recovery room discharge criteria met.
Time frame: Until recovery room discharge post surgery
3 secondary outcomes
Need for pharmacologic rescue from inadequate spinal block during the procedure.
Time frame: Until end of surgery
Time from entrance into recovery room until criteria for a recovery room discharge are met
Time frame: Until recovery room discharge criteria are met
Time from entrance into recovery room until criteria for a femoral nerve block for post-operative pain control are met
Time frame: Until criteria are met for post operative nerve block in recovery room
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 17 Apr 2009.
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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.
Melanie Jaeger, MD, FRCPSC principal investigator
Staff anesthesiologist at Kingston General Hospital
Dale Engen, MD, FRCPSC study director
Staff anesthesiologist at Kingston General Hospital
Devin Sydor, MD study director
Anesthesiology resident at Kingston General Hospital/Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low dose bupivicaine in spinal anesthetic and Standard dose bupivacaine in spinal anesthetic in people with Spinal Anesthesia and Total Knee Arthroplasty, run by Queen's University 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 1 inclusion and 9 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 17 Apr 2009. 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 from spinal injection of bupivicaine until recovery room discharge criteria met. (time frame: Until recovery room discharge post surgery). 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 17 Apr 2009.