Pain, AcuteNCT03143738
Comparison of Regional Anesthesia Techniques After Total Knee Arthroplasty
A study testing continuous anesthesia of adductor canal, continuous anesthesia of femoral nerve and Spinal anesthesia in people with Pain, Acute and Knee Arthropathy, run by Medical University of Lublin at 1 site in Poland.
Trial summary
Comparison of continuous adductor canal block to continuous femoral nerve block in patients after total knee arthroplasty. All patients will be anesthetized with spinal anesthesia. Continuous infusion of ropivacaine with a catheter implemented to the adductor canal or next to the femoral nerve. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain, Acute, Knee Arthropathy, Postoperative Pain
- What is being tested?
- continuous anesthesia of adductor canal, continuous anesthesia of femoral nerve and Spinal anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 24 Apr 2017to 26 Jul 2018
- 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
- knee arthroplasty
- obtained consent
- subarachnoid anaesthesia
Who cannot join
- coagulopathy
- allergy to to local anesthetics
- depression, antidepressant drugs treatment
- epilepsy
- usage of painkiller before surgery
- addiction to alcohol or recreational drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Continuous Adductor Canal Block in Comparison to Continuous Femoral Nerve Block in Patients After Total Knee Arthroplasty: Randomized Control Trail
Comparison of continuous adductor canal block to continuous femoral nerve block in patients after total knee arthroplasty.
All patients will be anesthetized with spinal anesthesia. Continuous infusion of ropivacaine with a catheter implemented to the adductor canal or next to the femoral nerve.
The observed goals: pain intensity, the beginning and quality of rehabilitation.
Read the detailed description
Written consent will be obtained a day before the surgery. Only subarachnoidally anaesthetised patients may participate in the study. Pencil-point spinal needle and bupivacaine (Marcaine Heavy Spinal 0.5 %) will be used.
Before the beginning of operation, under ultrasound control, a catheter will be implemented to one of the chosen position: the adductor canal (the middle or lower third of thigh) or near the femoral nerve (below the inguinal ligament). The local anesthetic solution of 0.2 % ropivacaine will be started with an elastomeric pump (5 mL per hour, up to 72 hours) as soon as a catheter in the right position.
The pain will be measured with VAS (visual-analogue scale) 8, 24 and 48 hours after the end of operation, and at the discharge. At the same time, i.e.: 8, 24 and 48 hours from the end of surgery, the range of flexion and extension in the operated knee will be assessed. Moreover, the possibility of patient's sitting, standing up and walking will be noted.
All parameters will be reassessed before patients' discharge from the hospital. Each patient will receive paracetamol (1.0) and metamizol (1.0) intravenously (i.v.) q6h. 5 mg of morphine may be given as required, up to 2 dosages per day as a rescue medication.
- Conditions
- Pain, Acute, Knee Arthropathy, Postoperative Pain, Mobility Limitation
- Being tested
- continuous anesthesia of adductor canal, continuous anesthesia of femoral nerve, Spinal anesthesia
- Keywords
- regional anesthesia, knee replacement, pain treatment, rehabilitation
- Medical subject headings
- Acute Pain, Pain, Postoperative, Mobility Limitation, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous anesthesia of adductor canalProcedure or surgery
After subarachnoid anesthesia, but before the beginning of surgery, a catheter will be implemented to the adductor canal and infusion of 5 mL/h of 0.2 % ropivacaine will be started.
continuous anesthesia of femoral nerveProcedure or surgery
After subarachnoid anesthesia, but before the beginning of surgery, a catheter will be implemented next to the femoral nerve (below inguinal ligament) and infusion of 5 mL/h of 0.2 % ropivacaine will be started.
Spinal anesthesiaProcedure or surgery
Also called Subarachnoid anesthesia
Before the beginning of surgery all patients will be anesthetised with 0.5 % hyperbaric bupivacaine (Marcaine Heavy), 2.0 - 2.5 mL solution. Pencil point spinal needle will be used.
| Study group | Role | What they receive |
|---|---|---|
| continuous anesthesia of adductor canal | Experimental | Not described Receives: Procedure: continuous anesthesia of adductor canal; Procedure: Spinal anesthesia |
| continuous anesthesia of femoral nerve | Experimental | Not described Receives: Procedure: continuous anesthesia of femoral nerve; Procedure: Spinal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption
Total consumption of intravenous morphine by patients with the use of patient-controlled analgesia pump
Measured: 24 hours from the end of surgery
Secondary outcomes (4)
Knee flexion
range of flexion in operated knee
Measured: 8, 24, 48 hours from the end of surgery, and at the patient discharge from the hospital (an average 4-6 days)
Walking
Possibility of walking by patients at scheduled time points
Measured: 8, 24, 48 hours from the end of surgery, and at the patient discharge from the hospital (an average 4-6 days)
The change of acute postoperative pain
Measured with VAS (visual-analogue scale)
Measured: 8, 24, 48 hours from the end of surgery, and at the patient discharge from the hospital (an average 4-6 days)
Sitting
Possibility of walking by patients at scheduled time points
Measured: 8, 24, 48 hours from the end of surgery, and at the patient discharge from the hospital (an average 4-6 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study start24 Apr 2017
- Primary completion30 Jun 2018
- Study completion26 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, AcuteStudies 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
- Model description
- Two groups of patients randomly allocated: adductor canal group or femoral nerve group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Lublin
- Sponsor type
- University, hospital or other
- Collaborators
- Konskie Specjalist Hospital
- Responsible party
- Principal investigator, Michał Borys, Medical University of Lublin
- Investigators
- Michał Borys, M.D., PhD, Principal investigator, Medical University of Lublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03143738
- Sponsor's protocol ID
- KE-0254/188/2016
- Status last verified
- Feb 2019
- First submitted
- 3 May 2017
- Last updated
- 28 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Adductor Canal Block in Comparison to Continuous Femoral Nerve Block in Patients After Total Knee Arthroplasty: Randomized Control Trail
- ClinicalTrials.gov ID
- NCT03143738
- Acronym / sponsor ID
- KE-0254/188/2016
- Conditions
- Pain, Acute, Knee Arthropathy, Postoperative Pain, Mobility Limitation
- Keywords
- regional anesthesia, knee replacement, pain treatment, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Medical University of LublinUniversity, hospital or other
- Collaborators
- Konskie Specjalist Hospital
- Study start
- 24 Apr 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 26 Jul 2018 (actual)
- First posted
- 8 May 2017 (actual)
- 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.
Comparison of continuous adductor canal block to continuous femoral nerve block in patients after total knee arthroplasty.
All patients will be anesthetized with spinal anesthesia. Continuous infusion of ropivacaine with a catheter implemented to the adductor canal or next to the femoral nerve.
The observed goals: pain intensity, the beginning and quality of rehabilitation.
Detailed description
Written consent will be obtained a day before the surgery. Only subarachnoidally anaesthetised patients may participate in the study. Pencil-point spinal needle and bupivacaine (Marcaine Heavy Spinal 0.5 %) will be used.
Before the beginning of operation, under ultrasound control, a catheter will be implemented to one of the chosen position: the adductor canal (the middle or lower third of thigh) or near the femoral nerve (below the inguinal ligament). The local anesthetic solution of 0.2 % ropivacaine will be started with an elastomeric pump (5 mL per hour, up to 72 hours) as soon as a catheter in the right position.
The pain will be measured with VAS (visual-analogue scale) 8, 24 and 48 hours after the end of operation, and at the discharge. At the same time, i.e.: 8, 24 and 48 hours from the end of surgery, the range of flexion and extension in the operated knee will be assessed. Moreover, the possibility of patient's sitting, standing up and walking will be noted.
All parameters will be reassessed before patients' discharge from the hospital. Each patient will receive paracetamol (1.0) and metamizol (1.0) intravenously (i.v.) q6h. 5 mg of morphine may be given as required, up to 2 dosages per day as a rescue medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two groups of patients randomly allocated: adductor canal group or femoral nerve group
| Arm | Type | Receives |
|---|---|---|
| continuous anesthesia of adductor canal | Experimental | Procedure: continuous anesthesia of adductor canal, Procedure: Spinal anesthesia |
| continuous anesthesia of femoral nerve | Experimental | Procedure: continuous anesthesia of femoral nerve, Procedure: Spinal anesthesia |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- knee arthroplasty
- obtained consent
- subarachnoid anaesthesia
Key exclusion criteria (6 listed)
- coagulopathy
- allergy to to local anesthetics
- depression, antidepressant drugs treatment
- epilepsy
- usage of painkiller before surgery
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 |
|---|---|---|
| continuous anesthesia of adductor canalAfter subarachnoid anesthesia, but before the beginning of surgery, a catheter will be implemented to the adductor canal and infusion of 5 mL/h of 0.2 % ropivacaine will be started. | Procedure or surgery | continuous anesthesia of adductor canal |
| continuous anesthesia of femoral nerveAfter subarachnoid anesthesia, but before the beginning of surgery, a catheter will be implemented next to the femoral nerve (below inguinal ligament) and infusion of 5 mL/h of 0.2 % ropivacaine will be started. | Procedure or surgery | continuous anesthesia of femoral nerve |
| Spinal anesthesiaAlso: Subarachnoid anesthesiaBefore the beginning of surgery all patients will be anesthetised with 0.5 % hyperbaric bupivacaine (Marcaine Heavy), 2.0 - 2.5 mL solution. Pencil point spinal needle will be used. | Procedure or surgery | continuous anesthesia of adductor canal, continuous anesthesia of femoral nerve |
Primary outcome
Morphine consumption
Time frame: 24 hours from the end of surgery
Total consumption of intravenous morphine by patients with the use of patient-controlled analgesia pump
4 secondary outcomes
Knee flexion
Time frame: 8, 24, 48 hours from the end of surgery, and at the patient discharge from the hospital (an average 4-6 days)
Walking
Time frame: 8, 24, 48 hours from the end of surgery, and at the patient discharge from the hospital (an average 4-6 days)
The change of acute postoperative pain
Time frame: 8, 24, 48 hours from the end of surgery, and at the patient discharge from the hospital (an average 4-6 days)
Sitting
Time frame: 8, 24, 48 hours from the end of surgery, and at the patient discharge from the hospital (an average 4-6 days)
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 28 Feb 2019.
- Individual participant dataSharing planned: No
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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.
Michał Borys, M.D., PhD principal investigator
Medical University of Lublin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing continuous anesthesia of adductor canal, continuous anesthesia of femoral nerve and Spinal anesthesia in people with Pain, Acute and Knee Arthropathy, run by Medical University of Lublin at 1 site in Poland.
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 6 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 28 Feb 2019. 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 Poland. 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?
Morphine consumption (time frame: 24 hours from the end of 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 28 Feb 2019.