OsteoarthritisNCT00992082
Local Infiltration Analgesia or Intrathecal Morphine in Total Knee Arthroplasty
A study testing ropivacaine, ketorolac and epinephrine and morphine in people with Osteoarthritis, run by Region Örebro County at 1 site in Sweden.
Trial summary
The purpose of this study is to determine whether local infiltration analgesia is more effective than intrathecal morphine in reducing postoperative pain in total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- ropivacaine, ketorolac and epinephrine and morphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2009to Aug 2011
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for total knee arthroplasty under spinal anesthesia.
- Aged 40-85 yrs.
- ASA physical status I-III and mobility indicating normal postoperative mobilization.
Who cannot join
- Known allergy or intolerance to one of the study drugs.
- Serious liver-, heart- or renal decease.
- Rheumatoid arthritis.
- Chronic pain or bleeding disorder.
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Dept. of Orthopedic Surgery
Örebro, Örebro County, SE-70185
Per Essving, MD, +4619602100, per.essving@orebroll.se
Kjell Axelsson, Professor, +4619602100, kjell.axelsson@orebroll.se
About this study
The purpose of this study is to determine whether local infiltration analgesia is more effective than intrathecal morphine in reducing postoperative pain in total knee arthroplasty.
Read the detailed description
Postoperative pain is often severe following total knee arthroplasty. Spinal anesthesia is a common method in total knee arthroplasty. Adding morphine to the local anesthetic injected intrathecally prolongs the analgetic effect, but may give the usual opioid side effects. The Local Infiltration Analgesia (LIA) technique has proven effective in reducing postoperative pain in total knee arthroplasty. In the LIA technique a long-acting local anesthetic (ropivacaine), a nonsteroidal anti-inflammatory drug (ketorolac), and epinephrine are infiltrated intraoperatively and via an intraarticular catheter postoperatively.
The aim of this study is to evaluate if spinal anesthesia together with the LIA technique provide better postoperative pain relief and mobilization than spinal anesthesia with addition of morphine to the local anesthetic intrathecally. Primary end-point is morphine consumption the first 48 postoperative hours. Secondary end-points are pain intensity, knee function, time to home readiness, hospital stay, side effects and patient satisfaction. Patients are followed up to 3 months after surgery.
- Conditions
- Osteoarthritis
- Being tested
- ropivacaine, ketorolac and epinephrine, morphine
- Keywords
- Postoperative pain, Local Infiltration Analgesia, Knee arthroplasty
- Medical subject headings
- Osteoarthritis, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ropivacaine, ketorolac and epinephrineDrug
Spinal injection: bupivacaine 17.5 mg (3,5 mL) + 0.25 mL 0.9% saline. Local Infiltration Analgesia: 400 mg ropivacaine, 30 mg ketorolac and 0.5 mg epinephrine (total volume 166 ml) are infiltrated by the surgeon into the soft tissues peri-articularly during the operation. On the first and on the second postoperative morning, 200 mg ropivacaine, 30 mg ketorolac and 0.1 mg epinephrine, total volume 22 ml, are injected intraarticularly via the catheter.
morphineDrug
Spinal injection: bupivacaine 17.5 mg (3.5 mL) + 0.1 mg (0.25 mL) morphine. No intraarticular injections are given.
| Study group | Role | What they receive |
|---|---|---|
| Group LIA | Active comparator | Local Infiltration Analgesia Receives: Drug: ropivacaine, ketorolac and epinephrine |
| Group M | Active comparator | Intrathecal morphine Receives: Drug: morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption
Measured: The first 48 postoperative hours
Secondary outcomes (6)
Pain intensity
Measured: 0-3 months
Knee function
Measured: 0-3 months
Time to home readiness
Measured: 0-2 weeks
Hospital stay
Measured: 0-2 weeks
Side effects
Measured: 0-3 months
Patient satisfaction
Measured: 0-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2009 (estimated)
- Study startAug 2009
- Primary completionMay 2011 (estimated)
- Study completionAug 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00992082
- Sponsor's protocol ID
- RAK-Spinal
- Status last verified
- Oct 2009
- First submitted
- 7 Oct 2009
- Last updated
- 9 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Infiltration Analgesia or Intrathecal Morphine in Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT00992082
- Acronym / sponsor ID
- RAK-Spinal
- Conditions
- Osteoarthritis
- Keywords
- Postoperative pain, Local Infiltration Analgesia, Knee arthroplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- May 2011 (estimated)
- Study completion
- Aug 2011 (estimated)
- First posted
- 8 Oct 2009 (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 local infiltration analgesia is more effective than intrathecal morphine in reducing postoperative pain in total knee arthroplasty.
Detailed description
Postoperative pain is often severe following total knee arthroplasty. Spinal anesthesia is a common method in total knee arthroplasty. Adding morphine to the local anesthetic injected intrathecally prolongs the analgetic effect, but may give the usual opioid side effects. The Local Infiltration Analgesia (LIA) technique has proven effective in reducing postoperative pain in total knee arthroplasty. In the LIA technique a long-acting local anesthetic (ropivacaine), a nonsteroidal anti-inflammatory drug (ketorolac), and epinephrine are infiltrated intraoperatively and via an intraarticular catheter postoperatively.
The aim of this study is to evaluate if spinal anesthesia together with the LIA technique provide better postoperative pain relief and mobilization than spinal anesthesia with addition of morphine to the local anesthetic intrathecally. Primary end-point is morphine consumption the first 48 postoperative hours. Secondary end-points are pain intensity, knee function, time to home readiness, hospital stay, side effects and patient satisfaction. Patients are followed up to 3 months after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group LIA | Active comparator | Drug: ropivacaine, ketorolac and epinephrineLocal Infiltration Analgesia |
| Group M | Active comparator | Drug: morphineIntrathecal morphine |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients scheduled for total knee arthroplasty under spinal anesthesia.
- Aged 40-85 yrs.
- ASA physical status I-III and mobility indicating normal postoperative mobilization.
Key exclusion criteria (4 listed)
- Known allergy or intolerance to one of the study drugs.
- Serious liver-, heart- or renal decease.
- Rheumatoid arthritis.
- Chronic pain or bleeding disorder.
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 |
|---|---|---|
| ropivacaine, ketorolac and epinephrineSpinal injection: bupivacaine 17.5 mg (3,5 mL) + 0.25 mL 0.9% saline. Local Infiltration Analgesia: 400 mg ropivacaine, 30 mg ketorolac and 0.5 mg epinephrine (total volume 166 ml) are infiltrated by the surgeon into the soft tissues peri-articularly during the operation. On the first and on the second postoperative morning, 200 mg ropivacaine, 30 mg ketorolac and 0.1 mg epinephrine, total volume 22 ml, are injected intraarticularly via the catheter. | Drug | Group LIA |
| morphineSpinal injection: bupivacaine 17.5 mg (3.5 mL) + 0.1 mg (0.25 mL) morphine. No intraarticular injections are given. | Drug | Group M |
Primary outcome
Morphine consumption
Time frame: The first 48 postoperative hours
6 secondary outcomes
Pain intensity
Time frame: 0-3 months
Knee function
Time frame: 0-3 months
Time to home readiness
Time frame: 0-2 weeks
Hospital stay
Time frame: 0-2 weeks
Side effects
Time frame: 0-3 months
Patient satisfaction
Time frame: 0-3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ropivacaine, ketorolac and epinephrine and morphine in people with Osteoarthritis, run by Region Örebro County 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 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: status not confirmed, as of the sponsor's last update on 9 Oct 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Per Essving, MD (+4619602100, per.essving@orebroll.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphine consumption (time frame: The first 48 postoperative 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 9 Oct 2009.