Postoperative PainPhase 4API-KNEENCT03372265
Catheter-based Peripheral Regional Anesthesia After Total Knee Arthroplasty
A Phase 4 study testing Ropivacaine 0.2% in people with Postoperative Pain, run by Nordsjaellands Hospital at 1 site in Denmark.
Trial summary
BACKGROUND Total knee arthroplasty can be severely painful, and peripheral regional anesthesia is highly recommended as part of the perioperative pain treatment. Whether catheter-based techniques are better than single injection techniques are debatable. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Ropivacaine 0.2%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteDenmark
- Study dates
- 6 Dec 2017to 1 Apr 2019
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- American Society of Anesthesiologists Classification I-III
- Normal cognitive function in order to sign written, informed consent and to understand trial protocol
- Agreement to the trial protocol, including the randomized manner
Who cannot join
- Allergy to LA
- Infection in or near insertion site of the peripheral nerve catheter
- Anatomical abnormalities preventing successful peripheral catheter insertion
- Habitual use of opioids
- Pregnancy or breastfeeding (disproved by a negative pregnancy test before trial inclusion)
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Anesthesiology, Nordsjællands Hospital Hillerød
Hillerød, DK-3400
About this study
Official title: Catheter-based Peripheral Regional Anesthesia After Total Knee Arthroplasty: Comparison of Low Dose, Automated Periodic Infusions With Conventional High Dose, Continuous Infusion and Patient-initiated Infusions Only
BACKGROUND
Total knee arthroplasty can be severely painful, and peripheral regional anesthesia is highly recommended as part of the perioperative pain treatment. Whether catheter-based techniques are better than single injection techniques are debatable. Furthermore, in catheter-based techniques, whether a low-dose automated, periodic infusion can produce similar analgesic effectiveness compared to a conventional, high dose, continuous infusion has never been explored.
AIM Comparison of the analgesic effectiveness of a low-dose automated, periodic infusion, a conventional continuous infusion and patient-controlled boluses only in catheter-based adductor canal blocks for patients undergoing total knee arthrplasty.
Read the detailed description
BACKGROUND
Total knee arthroplasty (TKA) is a very common procedure, with more than 600.000 being performed annually in the US alone. This number is expected to increase to more than 3 million by 2030. The procedure is associated with intense, early postoperative pain, and half of the patients report moderate to severe pain the first 2-3 postoperative days (POD). Peripheral regional anesthesia (PRA) using single injection nerve blocks is highly recommended as part of a multimodal, perioperative, analgesic treatment.
Patients who are expected to have postoperative, severe pain exceeding the duration of a single injection nerve block may benefit from a catheter-based nerve block (CBNB) using either a continuous infusion (CI) or intermittent infusions of local anesthetics (LA). Intermittent boluses can be either patient-controlled or prescribed in combination with a continuous infusion or as prespecified intermittent boluses. Whether a CBNB treatment is superior to a single injection nerve block after orthopedic surgery remains unanswered. There are several challenges when using a CBNB treatment: The dosing or delivery method may be either insufficient and thus not pain relieving or too powerful resulting in dense motor block and limb anesthesia which may compromise safety and rehabilitation. The peripheral nerve block catheter may also displace and therefore deposit LA too far from the targeted nerve(s) to produce an effective nerve block.
Previous studies suggest that an automated periodic infusion (API) regimen is superior to CI. It seems that an API produces better pain control, a lower analgesic consumption over time and less motor inhibition. This is welldescribed for epidural catheters for laboring women, but evidence is also apparent in PRA. Adding a PCA bolus option to a catheter-based nerve block treatment may even out the difference in pain scores between API and CI.
However, it seems that API groups require less LA via PCA function. Reducing LA consumption is of great importance for ambulatory patients whose LA reservoir is limited, but also for all other orthopedic patients whose motor block should be minimized in order to optimize rehabilitation.
OBJECTIVES
To investigate whether a low-dose API with patient-controlled bolus option can produce a similar analgesic effect compared to a conventional, high dose, CI with patient-controlled bolus option in catheter-based peripheral nerve blocks for patients undergoing total knee arthrplasty.
Analgesic effectiveness will be compared with a group only given the patient controlled bolus option.
HYPOTHESIS
Low dose API with supplemental patient-controlled bolus option will provide pain-relieving therapy not inferior to a conventional CI with supplemental patient-controlled bolus option. The intervention group receiving patient-controlled boluses only will experience more pain breakthrough.
- Conditions
- Postoperative Pain
- Being tested
- Ropivacaine 0.2%
- Keywords
- Peripheral regional anesthesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine 0.2%Drug
Also called Naropin 0.2%
Perineural infusion using a peripheral nerve block catheter and a portable infusion pump.
| Study group | Role | What they receive |
|---|---|---|
| API+PCA | Experimental | Infusion of ropivacaine 0.2 %, 15 mL, every 10th hour. Patient-initiated bolus of ropivacaine 0,2 %, 15 mL. Lock-out time: 5 hours. Receives: Drug: Ropivacaine 0.2% |
| CI+PCA | Active comparator | Continuous infusion of ropivacaine 0.2 %, 6 mL/hour. Patient-initiated bolus of ropivacaine 0,2 %, 15 mL. Lock-out time: 5 hours. Receives: Drug: Ropivacaine 0.2% |
| PCA only | Active comparator | Patient-initiated bolus of ropivacaine 0,2 %, 15 mL. Lock-out time: 5 hours. Receives: Drug: Ropivacaine 0.2% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain, 1-72 hours postoperatively
Postoperative pain using the visual analogue pain scale (VAS, 0-100 milimetres). Measurements will be patient-reported.
Measured: 1-72 hours
Secondary outcomes (2)
Opioid consumption, 1-72 hours postoperatively
Tablets consumed during the period of investigation
Measured: 1-72 hours
Volume of patient-initiated boluses, 1-72 hours postoperatively
Volume of ropivacaine 0.2 % (mL) used for patient-initiated boluses, 1-72 hours postoperatively
Measured: 1-72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study start6 Dec 2017
- Primary completion1 Feb 2019
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Model description
- 3 arms (API, CI and PCA only)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordsjaellands Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claus Behrend Christiansen, Nordsjaellands Hospital
- Investigators
- Kai Henrik Wiborg Lange, DMSci, Study director, Department of Anesthesiology, Nordsjaellands Hospital & University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03372265
- Sponsor's protocol ID
- H-17021068
- Acronym
- API-KNEE
- Status last verified
- Sep 2019
- First submitted
- 10 Dec 2017
- Last updated
- 17 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Catheter-based Peripheral Regional Anesthesia After Total Knee Arthroplasty: Comparison of Low Dose, Automated Periodic Infusions With Conventional High Dose, Continuous Infusion and Patient-initiated Infusions Only
- ClinicalTrials.gov ID
- NCT03372265
- Acronym / sponsor ID
- API-KNEE / H-17021068
- Conditions
- Postoperative Pain
- Keywords
- Peripheral regional anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Nordsjaellands HospitalUniversity, hospital or other
- Study start
- 6 Dec 2017 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 13 Dec 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.
BACKGROUND
Total knee arthroplasty can be severely painful, and peripheral regional anesthesia is highly recommended as part of the perioperative pain treatment. Whether catheter-based techniques are better than single injection techniques are debatable. Furthermore, in catheter-based techniques, whether a low-dose automated, periodic infusion can produce similar analgesic effectiveness compared to a conventional, high dose, continuous infusion has never been explored.
AIM Comparison of the analgesic effectiveness of a low-dose automated, periodic infusion, a conventional continuous infusion and patient-controlled boluses only in catheter-based adductor canal blocks for patients undergoing total knee arthrplasty.
Detailed description
BACKGROUND
Total knee arthroplasty (TKA) is a very common procedure, with more than 600.000 being performed annually in the US alone. This number is expected to increase to more than 3 million by 2030. The procedure is associated with intense, early postoperative pain, and half of the patients report moderate to severe pain the first 2-3 postoperative days (POD). Peripheral regional anesthesia (PRA) using single injection nerve blocks is highly recommended as part of a multimodal, perioperative, analgesic treatment.
Patients who are expected to have postoperative, severe pain exceeding the duration of a single injection nerve block may benefit from a catheter-based nerve block (CBNB) using either a continuous infusion (CI) or intermittent infusions of local anesthetics (LA). Intermittent boluses can be either patient-controlled or prescribed in combination with a continuous infusion or as prespecified intermittent boluses. Whether a CBNB treatment is superior to a single injection nerve block after orthopedic surgery remains unanswered. There are several challenges when using a CBNB treatment: The dosing or delivery method may be either insufficient and thus not pain relieving or too powerful resulting in dense motor block and limb anesthesia which may compromise safety and rehabilitation. The peripheral nerve block catheter may also displace and therefore deposit LA too far from the targeted nerve(s) to produce an effective nerve block.
Previous studies suggest that an automated periodic infusion (API) regimen is superior to CI. It seems that an API produces better pain control, a lower analgesic consumption over time and less motor inhibition. This is welldescribed for epidural catheters for laboring women, but evidence is also apparent in PRA. Adding a PCA bolus option to a catheter-based nerve block treatment may even out the difference in pain scores between API and CI.
However, it seems that API groups require less LA via PCA function. Reducing LA consumption is of great importance for ambulatory patients whose LA reservoir is limited, but also for all other orthopedic patients whose motor block should be minimized in order to optimize rehabilitation.
OBJECTIVES
To investigate whether a low-dose API with patient-controlled bolus option can produce a similar analgesic effect compared to a conventional, high dose, CI with patient-controlled bolus option in catheter-based peripheral nerve blocks for patients undergoing total knee arthrplasty.
Analgesic effectiveness will be compared with a group only given the patient controlled bolus option.
HYPOTHESIS
Low dose API with supplemental patient-controlled bolus option will provide pain-relieving therapy not inferior to a conventional CI with supplemental patient-controlled bolus option. The intervention group receiving patient-controlled boluses only will experience more pain breakthrough.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 3 arms (API, CI and PCA only)
| Arm | Type | Receives |
|---|---|---|
| API+PCA | Experimental | Drug: Ropivacaine 0.2%Infusion of ropivacaine 0.2 %, 15 mL, every 10th hour. Patient-initiated bolus of ropivacaine 0,2 %, 15 mL. Lock-out time: 5 hours. |
| CI+PCA | Active comparator | Drug: Ropivacaine 0.2%Continuous infusion of ropivacaine 0.2 %, 6 mL/hour. Patient-initiated bolus of ropivacaine 0,2 %, 15 mL. Lock-out time: 5 hours. |
| PCA only | Active comparator | Drug: Ropivacaine 0.2%Patient-initiated bolus of ropivacaine 0,2 %, 15 mL. Lock-out time: 5 hours. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- American Society of Anesthesiologists Classification I-III
- Normal cognitive function in order to sign written, informed consent and to understand trial protocol
- Agreement to the trial protocol, including the randomized manner
Key exclusion criteria (5 listed)
- Allergy to LA
- Infection in or near insertion site of the peripheral nerve catheter
- Anatomical abnormalities preventing successful peripheral catheter insertion
- Habitual use of opioids
- Pregnancy or breastfeeding (disproved by a negative pregnancy test before trial inclusion)
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 0.2%Also: Naropin 0.2%Perineural infusion using a peripheral nerve block catheter and a portable infusion pump. | Drug | API+PCA, CI+PCA, PCA only |
Primary outcome
Postoperative pain, 1-72 hours postoperatively
Time frame: 1-72 hours
Postoperative pain using the visual analogue pain scale (VAS, 0-100 milimetres). Measurements will be patient-reported.
2 secondary outcomes
Opioid consumption, 1-72 hours postoperatively
Time frame: 1-72 hours
Volume of patient-initiated boluses, 1-72 hours postoperatively
Time frame: 1-72 hours
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 Sep 2019.
- Individual participant dataSharing planned: Undecided
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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.
Kai Henrik Wiborg Lange, DMSci study director
Department of Anesthesiology, Nordsjaellands Hospital & University of Copenhagen
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 Ropivacaine 0.2% in people with Postoperative Pain, run by Nordsjaellands Hospital 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 5 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 Sep 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 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?
Postoperative pain, 1-72 hours postoperatively (time frame: 1-72 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 17 Sep 2019.