Total Knee ArthroplastyPhase 4HobsaliNCT02067078
Protracted Effect of Combined Nerve Blocks After Total Knee Arthroplasty
A Phase 4 study testing Dexamethasone 4 mg + Clonidine 75 microgram + Marcaine 90 mg + Adrenaline 90 microgram, Dexamethasone 2 mg + Clonidine 37,5 microgram + Marcaine 45 mg + Adrenaline 45 microgram and Ropivacaine + Toradol + Adrenaline in people with Total Knee Arthroplasty and Pain, run by Regionshospitalet Silkeborg at 1 site in Denmark.
Trial summary
Purpose: The purpose of this study is to evaluate the postoperative analgesic effect of a combined Saphenous nerve block and Obturator nerve block with local infiltration analgesia in the tissue around the knee after surgery with knee replacement. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Total Knee Arthroplasty, Pain, Nerve Blocks
- What is being tested?
- Dexamethasone 4 mg + Clonidine 75 microgram + Marcaine 90 mg + Adrenaline 90 microgram, Dexamethasone 2 mg + Clonidine 37,5 microgram + Marcaine 45 mg + Adrenaline 45 microgram and Ropivacaine + Toradol + Adrenaline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2014to Dec 2014
- Phase
- Phase 4
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 50 years
- Patients set to cemented Total knee arthroplasty in spinal block
- Patients who have given written informed consent to participate in the study after having understood the contents of the protocol and limitations fully
- Illness score 1-3
Who cannot join
- Patients who can not cooperate with the investigation
- Patients who do not understand or speak Danish
- Patients receiving immunosuppressive therapy
- Patients with a treatment-dependent diabetes mellitus
- Patients with known neuropathy in the lower limbs
- Allergy to those drugs used in the study
Show all 9Show fewer
- Alcohol and / or drug abuse - the investigator's opinion
- Patients who can not tolerate Non steroid analgesic drugs
- Use of strong opioid several times a day (morphine, ketogan, Oxynorm, methadone, fentanyl)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Protracted Saphenous Nerve and Obturator Nerve Block Versus Saphenous Nerve Block Versus Local Infiltration Analgesia on Opioid Consumption, Pain, Block Duration of Action and Mobilization After Total Knee Arthroplasty.
Purpose:
The purpose of this study is to evaluate the postoperative analgesic effect of a combined Saphenous nerve block and Obturator nerve block with local infiltration analgesia in the tissue around the knee after surgery with knee replacement. In the combined nerve blocks we use a mixture of Bupivacaine, Adrenaline, Clonidine and Dexamethasone ("protracted mixture") and the local infiltration consist of Ropivacaine, Adrenaline and Toradol. Our hypothesis is that the combined nerve blocks with protracted mixture prolongs block duration, reduces pain and reduces the need for morphine and thus reduce side effects such as nausea, vomiting and lethargy compared to the current treatment with local infiltration analgesia.
Read more
Background:
Nerve blocks as analgesic treatment after orthopedic surgery is a recognized and proven procedure. The nerve blocks have the disadvantage that not only do they anesthetize the sensory nerve fibers but also the nerve fibers to the muscles of the leg. The Saphenous nerve block causes only stunning of sensory nerves to the knee region. The Obturator nerve block causes both stunning of the sensory nerves to the knee region and the thighs inward leading muscles, and does not affect the patient's mobilization capacity.
Both blocks are known to be a good addition to the analgesic treatment. Bupivacaine is a well-known local anesthetic. Adrenaline, Clonidine and Dexamethasone have also been used in other studies, in addition to the local anesthetic agent, and has been shown to prolong the effect of the nerve block. Saphenous and Obturator nerve block with all four drugs Bupivacaine, Adrenaline, Clonidine and Dexamethasone has not been systematically investigated in knee replacement surgery, and it is not known whether this method will provide better pain treatment.
Method
The patient can receive one of three treatments, determined randomly:
- A. Saphenous and Obturator nerve block with active anesthetics (Bupivacaine, Adrenaline, Clonidine, Dexamethasone) and local block around the knee joint with placebo medicine (normal saline).
- B. Saphenous block with active anesthetics and both Obturator nerve block and local block around the knee joint with placebo medicine (normal saline).
- C. Both block with placebo medicine (normal saline) and local block around the knee joint with effective local anesthetic.
Neither patient, investigator or staff around the patient will have knowledge of which treatment the patient has received.
The blocks will be injected before the operation and local infiltration around the knee joint will be given by the surgeon during the operation.
- Conditions
- Total Knee Arthroplasty, Pain, Nerve Blocks
- Being tested
- Dexamethasone 4 mg + Clonidine 75 microgram + Marcaine 90 mg + Adrenaline 90 microgram, Dexamethasone 2 mg + Clonidine 37,5 microgram + Marcaine 45 mg + Adrenaline 45 microgram, Ropivacaine + Toradol + Adrenaline
- Keywords
- nerve block, total knee arthroplasty, saphenous nerve block, obturator nerve block, pain, opioid consumption
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone 4 mg + Clonidine 75 microgram + Marcaine 90 mg + Adrenaline 90 microgramDrug
Dexamethasone 4 mg Clonidine 75 microgram Marcaine 90 mg Adrenaline 90 microgram
Dexamethasone 2 mg + Clonidine 37,5 microgram + Marcaine 45 mg + Adrenaline 45 microgramDrug
Dexamethasone 2 mg Clonidine 37,5 microgram Marcaine 45 mg Adrenaline 45 microgram
Ropivacaine + Toradol + AdrenalineDrug
Ropivacaine 300 mg + Toradol 45 mg + Adrenaline 0,75 mg
| Study group | Role | What they receive |
|---|---|---|
| Combined saphenous nerve and obturator nerve block | Experimental | Not described Receives: Drug: Dexamethasone 4 mg + Clonidine 75 microgram + Marcaine 90 mg + Adrenaline 90 microgram |
| Saphenous nerve block | Experimental | Not described Receives: Drug: Dexamethasone 2 mg + Clonidine 37,5 microgram + Marcaine 45 mg + Adrenaline 45 microgram |
| Local infiltration analgesia | Active comparator | Not described Receives: Drug: Ropivacaine + Toradol + Adrenaline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption
Measured: 1 to 24 hours postoperatively
Secondary outcomes (17)
Opioid consumption
Measured: 1 to 48 hours postoperatively
Pain Score by passive flexion of the knee joint from 0-90 degrees
numeric rating scale with values from 0 to 10, with 0 being no pain and 10 being the worst pain imaginable
Measured: Time 1, 2, 5, 7, 24, 31, 48 hours postoperatively
Pain Score at rest
Numeric rating scale with values from 0 to 10, with 0 being no pain and 10 being the worst pain imaginable
Measured: Time 1, 2 , 5, 7 , 24, 31 and 48 hours postoperatively
Patient-reported time to first postoperative breakthrough pain
Measured: Time 1 - 48 hours postoperatively
Nausea
numeric rating scale with values from 0 to 10, where 0 is no nausea and 10 being the worst nausea
Measured: Time 1, 2 , 5, 7 , 24, 31 and 48 hours postoperatively .
Vomiting
Measured: Number of between 24 hours postoperatively
Ondansetron
Measured: Consumption at time 24 hours postoperative
Number of nights with patient-reported sleep disruptions
Measured: Time 48 hours postoperatively
Duration of stay in the post anesthesia care unit
Measured: 1 - 48 hours postoperatively
Discharge time from the hospital
Measured: Time 1 hour to 2 weeks postoperatively
Patient-reported consumption of opioid
Measured: From the discharge date from hospital to ambulatory monitoring 2 weeks postoperatively
Quantitative satisfaction of pain
By indicating satisfaction score (0-10 ) , where the value 0 = complete dissatisfaction and 10 = complete satisfaction.
Measured: At 2 weeks postoperatively
Isometric tests of muscle strength in the hip adductors
The patient performed 4-10 measurements with a 30 second break in between each measurement. The difference between the highest value for the test before and after blockade construction calculated.
Measured: 1-2 hours preoperatively and again 30 minutes after the application of obturator nerve blockade
Time at mobilization to walk with or without support in the form of a walker, crutches or caregivers.
Measured: Time 1 to 48 hours postoperatively
Timed Up and Go test
The patient rise from a chair and walk round 3 metres and sit on the chair again . The time for completion of the test are recorded .
Measured: 1-2 hours preoperatively, 24 hours and 2 weeks postoperatively
Cumulated Ambulation Score to illustrate the basic level of mobilization
The patient scores based on 3 gradations according to their ability to mobilize up and in bed, getting up from a chair and walk with or without aids in the form of high walker or crutches
Measured: 1-2 hours pre-operatively, during the first postoperative mobilization, and time 24 hours postoperatively
Movement of the knee joint
The patient ability to extend and flex in the knee joint are recorded. The tests are performed with a goniometer
Measured: 1-2 hours preoperatively, 24 hours and 2 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regionshospitalet Silkeborg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charlotte Runge, Regionshospitalet Silkeborg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02067078
- Sponsor's protocol ID
- 2013-005010-36
- Acronym
- Hobsali
- Status last verified
- Feb 2015
- First submitted
- 16 Feb 2014
- Last updated
- 4 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Protracted Saphenous Nerve and Obturator Nerve Block Versus Saphenous Nerve Block Versus Local Infiltration Analgesia on Opioid Consumption, Pain, Block Duration of Action and Mobilization After Total Knee Arthroplasty.
- ClinicalTrials.gov ID
- NCT02067078
- Acronym / sponsor ID
- Hobsali / 2013-005010-36
- Conditions
- Total Knee Arthroplasty, Pain, Nerve Blocks
- Keywords
- nerve block, total knee arthroplasty, saphenous nerve block, obturator nerve block, pain, opioid consumption
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Regionshospitalet SilkeborgUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 20 Feb 2014 (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.
Purpose:
The purpose of this study is to evaluate the postoperative analgesic effect of a combined Saphenous nerve block and Obturator nerve block with local infiltration analgesia in the tissue around the knee after surgery with knee replacement. In the combined nerve blocks we use a mixture of Bupivacaine, Adrenaline, Clonidine and Dexamethasone ("protracted mixture") and the local infiltration consist of Ropivacaine, Adrenaline and Toradol. Our hypothesis is that the combined nerve blocks with protracted mixture prolongs block duration, reduces pain and reduces the need for morphine and thus reduce side effects such as nausea, vomiting and lethargy compared to the current treatment with local infiltration analgesia.
Background:
Nerve blocks as analgesic treatment after orthopedic surgery is a recognized and proven procedure. The nerve blocks have the disadvantage that not only do they anesthetize the sensory nerve fibers but also the nerve fibers to the muscles of the leg. The Saphenous nerve block causes only stunning of sensory nerves to the knee region. The Obturator nerve block causes both stunning of the sensory nerves to the knee region and the thighs inward leading muscles, and does not affect the patient's mobilization capacity.
Both blocks are known to be a good addition to the analgesic treatment. Bupivacaine is a well-known local anesthetic. Adrenaline, Clonidine and Dexamethasone have also been used in other studies, in addition to the local anesthetic agent, and has been shown to prolong the effect of the nerve block. Saphenous and Obturator nerve block with all four drugs Bupivacaine, Adrenaline, Clonidine and Dexamethasone has not been systematically investigated in knee replacement surgery, and it is not known whether this method will provide better pain treatment.
Method
The patient can receive one of three treatments, determined randomly:
- A. Saphenous and Obturator nerve block with active anesthetics (Bupivacaine, Adrenaline, Clonidine, Dexamethasone) and local block around the knee joint with placebo medicine (normal saline).
- B. Saphenous block with active anesthetics and both Obturator nerve block and local block around the knee joint with placebo medicine (normal saline).
- C. Both block with placebo medicine (normal saline) and local block around the knee joint with effective local anesthetic.
Neither patient, investigator or staff around the patient will have knowledge of which treatment the patient has received.
The blocks will be injected before the operation and local infiltration around the knee joint will be given by the surgeon during the operation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Combined saphenous nerve and obturator nerve block | Experimental | Drug: Dexamethasone 4 mg + Clonidine 75 microgram + Marcaine 90 mg + Adrenaline 90 microgram |
| Saphenous nerve block | Experimental | Drug: Dexamethasone 2 mg + Clonidine 37,5 microgram + Marcaine 45 mg + Adrenaline 45 microgram |
| Local infiltration analgesia | Active comparator | Drug: Ropivacaine + Toradol + Adrenaline |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 50 years
- Patients set to cemented Total knee arthroplasty in spinal block
- Patients who have given written informed consent to participate in the study after having understood the contents of the protocol and limitations fully
- Illness score 1-3
Key exclusion criteria (9 listed)
- Patients who can not cooperate with the investigation
- Patients who do not understand or speak Danish
- Patients receiving immunosuppressive therapy
- Patients with a treatment-dependent diabetes mellitus
- Patients with known neuropathy in the lower limbs
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 |
|---|---|---|
| Dexamethasone 4 mg + Clonidine 75 microgram + Marcaine 90 mg + Adrenaline 90 microgramDexamethasone 4 mg Clonidine 75 microgram Marcaine 90 mg Adrenaline 90 microgram | Drug | Combined saphenous nerve and obturator nerve block |
| Dexamethasone 2 mg + Clonidine 37,5 microgram + Marcaine 45 mg + Adrenaline 45 microgramDexamethasone 2 mg Clonidine 37,5 microgram Marcaine 45 mg Adrenaline 45 microgram | Drug | Saphenous nerve block |
| Ropivacaine + Toradol + AdrenalineRopivacaine 300 mg + Toradol 45 mg + Adrenaline 0,75 mg | Drug | Local infiltration analgesia |
Primary outcome
Opioid consumption
Time frame: 1 to 24 hours postoperatively
17 secondary outcomes
Opioid consumption
Time frame: 1 to 48 hours postoperatively
Pain Score by passive flexion of the knee joint from 0-90 degrees
Time frame: Time 1, 2, 5, 7, 24, 31, 48 hours postoperatively
Pain Score at rest
Time frame: Time 1, 2 , 5, 7 , 24, 31 and 48 hours postoperatively
Patient-reported time to first postoperative breakthrough pain
Time frame: Time 1 - 48 hours postoperatively
Nausea
Time frame: Time 1, 2 , 5, 7 , 24, 31 and 48 hours postoperatively .
Vomiting
Time frame: Number of between 24 hours postoperatively
Ondansetron
Time frame: Consumption at time 24 hours postoperative
Number of nights with patient-reported sleep disruptions
Time frame: Time 48 hours postoperatively
Duration of stay in the post anesthesia care unit
Time frame: 1 - 48 hours postoperatively
Discharge time from the hospital
Time frame: Time 1 hour to 2 weeks postoperatively
Patient-reported consumption of opioid
Time frame: From the discharge date from hospital to ambulatory monitoring 2 weeks postoperatively
Quantitative satisfaction of pain
Time frame: At 2 weeks postoperatively
Isometric tests of muscle strength in the hip adductors
Time frame: 1-2 hours preoperatively and again 30 minutes after the application of obturator nerve blockade
Time at mobilization to walk with or without support in the form of a walker, crutches or caregivers.
Time frame: Time 1 to 48 hours postoperatively
Timed Up and Go test
Time frame: 1-2 hours preoperatively, 24 hours and 2 weeks postoperatively
Cumulated Ambulation Score to illustrate the basic level of mobilization
Time frame: 1-2 hours pre-operatively, during the first postoperative mobilization, and time 24 hours postoperatively
Movement of the knee joint
Time frame: 1-2 hours preoperatively, 24 hours and 2 weeks postoperatively
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 4 Feb 2015.
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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 Phase 4 study testing Dexamethasone 4 mg + Clonidine 75 microgram + Marcaine 90 mg + Adrenaline 90 microgram, Dexamethasone 2 mg + Clonidine 37,5 microgram + Marcaine 45 mg + Adrenaline 45 microgram and Ropivacaine + Toradol + Adrenaline in people with Total Knee Arthroplasty and Pain, run by Regionshospitalet Silkeborg at 1 site in Denmark.
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 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 4 Feb 2015. 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 Denmark. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Opioid consumption (time frame: 1 to 24 hours postoperatively). 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 4 Feb 2015.