ArthritisNCT01312298
General vs. Intrathecal Anesthesia for Total Knee Arthroplasty
A study testing General anesthesia and Regional anesthesia in people with Arthritis, run by Region Skane at 1 site in Sweden.
Trial summary
Hypothesis: General anesthesia as compared to intrathecal (i.e. spinal anesthesia) anesthesia will result in shorter length of hospital stay for patients undergoing total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Arthritis
- What is being tested?
- General anesthesia and Regional anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2011to Jan 2013
- 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 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with osteoarthritis scheduled for surgery
- patients that will require Total Knee Arthroplasty
- patients over 45 yrs and under 85 yrs
- patients that understand the given information and are willing to participate in this study
- patients who have signed the informed consent document
Who cannot join
- prior surgery to the same knee
- patients with a history of stroke or neurological or psychiatric disease that potentially could affect the perception of pain
- obesity (BMI> 35)
- active or suspected infection
- patients taking opioids or steroids
- patients suffering from rheumatoid arthritis or have a immunological depression.
- patients who are allergic to any of the drugs being used in this study
- patients with other severe medical problems that could affect the perioperative course.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: General vs. Intrathecal Anesthesia Fort Total Knee Arthroplasty; a Randomized Clinical Trial
Hypothesis: General anesthesia as compared to intrathecal (i.e. spinal anesthesia) anesthesia will result in shorter length of hospital stay for patients undergoing total knee arthroplasty.
Primary endpoint: time from end of surgery until the patient is "street ready"
Secondary endpoints: will general anesthesia produce less postoperative pain as compared to intrathecal anesthesia? Is there any difference in post operative "dizziness" between the groups.
Read the detailed description
Hypothesis: General anaesthesia compared to intrathecal anaesthesia will give shorter length of hospital stay (LOS) for patients undergoing total knee arthroplasty (TKA).
Primary endpoint: time from end of surgery until the patient meets the discharge criteria.
Secondary endpoints:
- Will general anesthesia produce less post operative pain?
- Is there any difference in post operative orthostatic function (dizziness) between the groups?
- Time until the patient meets the discharge criteria from PACU
- How many patients will need at least one urinary bladder catheterization?
- Conditions
- Arthritis
- Being tested
- General anesthesia, Regional anesthesia
- Keywords
- Arthritis, General anaesthesia, Spinal anaesthesia
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General anesthesiaProcedure or surgery
Also called Suxamethonium 50 mg/ml is used to fascilitate intubation. Ventilation is done using oxygen and air.
Patients will receive general anesthesia using propofol 10 mg/ml and remifentanil 50 ug/ml
Regional anesthesiaProcedure or surgery
Also called Patients will receive bupivacaine 5 mg/ml intrathecally. Also the will receive propofol 10 mg/ml to produce a ligth level of sedation.
Patients will receive intrathecal anesthesia
| Study group | Role | What they receive |
|---|---|---|
| General Anesthesia | Experimental | Patients allocated to this arm will receive general anesthesia using propofol 10 mg/ml and remifentanil 50 ug/ml in a Target Controlled Infusion (TCI) Receives: Procedure: General anesthesia |
| Regional anesthesia | Active comparator | Patients will receive intrathecal anesthesia Receives: Procedure: Regional anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
time from end of surgery until patient is "street ready"
Time from end of surgery until the patient is street ready will be monitored. If the patient is street ready will be evaluated twice daily each day after the surgery.
Measured: within 4 days after surgery
Secondary outcomes (1)
Will general anesthesia produce less post operative pain as compared to intrathecal?
Pain will be measured using a visual analogue scale. The patient's own evaluation (questionnaires about quality of life and knee function)
- Time of post-op department, total time in hospital.
- Evaluation of patient outcomes, clinical and radiographic evaluation will be done before surgery, after surgery, and after 3 months, after 1year
- Data collection will be done through normal medical records and patient evaluations collected in a separate file in the clinic. Data is collected and processed by the Research Unit at the orthopedic clinic in Hässleholm.
Measured: 48 hrs after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2011 (estimated)
- Study startAug 2011
- Primary completionJun 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ArthritisStudies of the same condition, open and under way.
- More trials run by Region SkaneThe 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
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sören Toksvig-Larsen, M.D. PhD, Principal investigator, Dept Ortopedic surgery, Hässleholm Hospital, SWEDEN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01312298
- Sponsor's protocol ID
- OpHas2011/3
- Other IDs
- Copenhagen study 2011:1
- Status last verified
- Jan 2013
- First submitted
- 8 Mar 2011
- Last updated
- 7 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fowler SJ, Symons J, Sabato S, Myles PS. Epidural analgesia compared with peripheral nerve blockade after major knee surgery: a systematic review and meta-analysis of randomized trials. Br J Anaesth. 2008 Feb;100(2):154-64. doi: 10.1093/bja/aem373.
PubMed 18211990Minto CF, Schnider TW, Shafer SL. Pharmacokinetics and pharmacodynamics of remifentanil. II. Model application. Anesthesiology. 1997 Jan;86(1):24-33. doi: 10.1097/00000542-199701000-00005.
PubMed 9009936Andersen LO, Husted H, Otte KS, Kristensen BB, Kehlet H. High-volume infiltration analgesia in total knee arthroplasty: a randomized, double-blind, placebo-controlled trial. Acta Anaesthesiol Scand. 2008 Nov;52(10):1331-5. doi: 10.1111/j.1399-6576.2008.01777.x.
PubMed 19025523
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- General vs. Intrathecal Anesthesia Fort Total Knee Arthroplasty; a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01312298
- Acronym / sponsor ID
- OpHas2011/3
- Conditions
- Arthritis
- Keywords
- Arthritis, General anaesthesia, Spinal anaesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 10 Mar 2011 (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.
Hypothesis: General anesthesia as compared to intrathecal (i.e. spinal anesthesia) anesthesia will result in shorter length of hospital stay for patients undergoing total knee arthroplasty.
Primary endpoint: time from end of surgery until the patient is "street ready"
Secondary endpoints: will general anesthesia produce less postoperative pain as compared to intrathecal anesthesia? Is there any difference in post operative "dizziness" between the groups.
Detailed description
Hypothesis: General anaesthesia compared to intrathecal anaesthesia will give shorter length of hospital stay (LOS) for patients undergoing total knee arthroplasty (TKA).
Primary endpoint: time from end of surgery until the patient meets the discharge criteria.
Secondary endpoints:
- Will general anesthesia produce less post operative pain?
- Is there any difference in post operative orthostatic function (dizziness) between the groups?
- Time until the patient meets the discharge criteria from PACU
- How many patients will need at least one urinary bladder catheterization?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General Anesthesia | Experimental | Procedure: General anesthesiaPatients allocated to this arm will receive general anesthesia using propofol 10 mg/ml and remifentanil 50 ug/ml in a Target Controlled Infusion (TCI) |
| Regional anesthesia | Active comparator | Procedure: Regional anesthesiaPatients will receive intrathecal anesthesia |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patients with osteoarthritis scheduled for surgery
- patients that will require Total Knee Arthroplasty
- patients over 45 yrs and under 85 yrs
- patients that understand the given information and are willing to participate in this study
- patients who have signed the informed consent document
Key exclusion criteria (8 listed)
- prior surgery to the same knee
- patients with a history of stroke or neurological or psychiatric disease that potentially could affect the perception of pain
- obesity (BMI> 35)
- active or suspected infection
- patients taking opioids or steroids
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 |
|---|---|---|
| General anesthesiaAlso: Suxamethonium 50 mg/ml is used to fascilitate intubation. Ventilation is done using oxygen and air.Patients will receive general anesthesia using propofol 10 mg/ml and remifentanil 50 ug/ml | Procedure or surgery | General Anesthesia |
| Regional anesthesiaAlso: Patients will receive bupivacaine 5 mg/ml intrathecally. Also the will receive propofol 10 mg/ml to produce a ligth level of sedation.Patients will receive intrathecal anesthesia | Procedure or surgery | Regional anesthesia |
Primary outcome
time from end of surgery until patient is "street ready"
Time frame: within 4 days after surgery
Time from end of surgery until the patient is street ready will be monitored. If the patient is street ready will be evaluated twice daily each day after the surgery.
1 secondary outcome
Will general anesthesia produce less post operative pain as compared to intrathecal?
Time frame: 48 hrs 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 7 Mar 2013.
- Background: PubMed 18211990Fowler SJ, Symons J, Sabato S, Myles PS. Epidural analgesia compared with peripheral nerve blockade after major knee surgery: a systematic review and meta-analysis of randomized trials. Br J Anaesth. 2008 Feb;100(2):154-64. doi: 10.1093/bja/aem373.
- Background: PubMed 9009936Minto CF, Schnider TW, Shafer SL. Pharmacokinetics and pharmacodynamics of remifentanil. II. Model application. Anesthesiology. 1997 Jan;86(1):24-33. doi: 10.1097/00000542-199701000-00005.
- Background: PubMed 19025523Andersen LO, Husted H, Otte KS, Kristensen BB, Kehlet H. High-volume infiltration analgesia in total knee arthroplasty: a randomized, double-blind, placebo-controlled trial. Acta Anaesthesiol Scand. 2008 Nov;52(10):1331-5. doi: 10.1111/j.1399-6576.2008.01777.x.
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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.
Sören Toksvig-Larsen, M.D. PhD principal investigator
Dept Ortopedic surgery, Hässleholm Hospital, SWEDEN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing General anesthesia and Regional anesthesia in people with Arthritis, run by Region Skane at 1 site in Sweden.
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 5 inclusion and 8 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 7 Mar 2013. 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 Sweden. 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 end of surgery until patient is "street ready" (time frame: within 4 days after surgery). 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 NCT01312298, which also lists 3 linked publications.
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 7 Mar 2013.