Postoperative PainPhase 4NCT03696095
Local Anesthetic Automated Intermittent Administration vs. Continuous Infusion Via Femoral Nerve Block.
A Phase 4 study testing Ropivacaine Hcl 0.2% Inj Bag 200Ml (PIB mode) and Ropivacaine Hcl 0.2% Inj Bag 200Ml (CI mode) in people with Postoperative Pain and Postoperative Complications, run by J P Lecoq at 1 site in Belgium.
Trial summary
This study evaluates the impact of local anesthetic administration regiment through peri-neural femoral nerve catheter on pain and motor block frequency, after total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain, Postoperative Complications
- What is being tested?
- Ropivacaine Hcl 0.2% Inj Bag 200Ml (PIB mode) and Ropivacaine Hcl 0.2% Inj Bag 200Ml (CI mode)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteBelgium
- Study dates
- 16 Apr 2018to 6 Dec 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- admitted for unilateral primary total knee arthroplasty.
Who cannot join
- ASA score > 3
- BMI > 40
- refusal of loco-regional technique.
- psychiatric disease.
- inability to understand/ use the Local anesthetic delivery pump.
- local anesthetic allergy,
Show all 9Show fewer
- porphyry,
- uncontrolled epilepsy,
- severe cardiac arrhythmia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Continuous Infusion vs. Programmed Intermittent Bolus of Ropivacaine Through Peri-neural Femoral Nerve Catheter After Total Knee Arthroplasty: Impact on Analgesia Quality and Motor Block Frequency.
This study evaluates the impact of local anesthetic administration regiment through peri-neural femoral nerve catheter on pain and motor block frequency, after total knee arthroplasty.
Read the detailed description
This study evaluates the impact of local anesthetic administration regiment through peri-neural femoral nerve catheter on pain and motor block frequency, after total knee arthroplasty. One group of patients will receive automated intermittent bolus, while the others will get a continuous infusion. In both cases, patients will be able to administer supplementary auto-bolus if required.
- Conditions
- Postoperative Pain, Postoperative Complications
- Being tested
- Ropivacaine Hcl 0.2% Inj Bag 200Ml (PIB mode), Ropivacaine Hcl 0.2% Inj Bag 200Ml (CI mode)
- Keywords
- total knee arthroplasty, postoperative pain, programmed intermittent bolus, Continuous femoral nerve block
- Medical subject headings
- Pain, Postoperative, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine Hcl 0.2% Inj Bag 200Ml (PIB mode)Drug
Also called PIB
programmed intermittent bolus 5ml each one hour.
Ropivacaine Hcl 0.2% Inj Bag 200Ml (CI mode)Drug
Also called Continuous infusion
continuous infusion 6ml/h
| Study group | Role | What they receive |
|---|---|---|
| Continous infusion ropivacaine | Active comparator | Continuous infusion via peri-neural femoral nerve catheter of Ropivacaine Hcl 0.2% Inj Bag 200Ml (CI mode) at rate of 6ml/h + patient controlled bolus of 3ml ... Receives: Drug: Ropivacaine Hcl 0.2% Inj Bag 200Ml (CI mode) |
| PIB ropivacaine | Experimental | Programmed intermittent bolus of Ropivacaine Hcl 0.2% Inj Bag 200Ml (PIB mode) : 6ml each 60min + patient controlled bolus 3ml ... Receives: Drug: Ropivacaine Hcl 0.2% Inj Bag 200Ml (PIB mode) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of unplanned analgesia interventions.
Composite criteria including the frequency of unplanned analgesia interventions administered by the patient, or paramedical and medical staff, and by extenstion the total amount of opioids (in milligrams equivalent morphine) and local anesthetics (in milligrams) received in post-operative period.
Measured: up to 72 hours after surgery
Secondary outcomes (4)
Pain difference
Pain difference accessed by Numeric Pain Rating Scale (0-10), twice a day, at rest and on movement.
Measured: up to 72 hours after surgery
Motor block frequency
Accessed by physiotherapist twice a day, by testing the Quadriceps muscle.
Measured: up to 72 hours after surgery
Mobilization quality during physiotherapy sessions.
accessed by physiotherapist, ability to walk with or without help, take stairs, and flex and extend knee (comparatively to the opposite knee).
Measured: up to 72 hours after surgery
local anesthesia technique related complications
rate of complications including: hematoma, infection, catheter dislodgement or breakage, allergic events.
Measured: until catheter removal 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2018
- Study start16 Apr 2018
- Primary completion30 Nov 2018
- Study completion6 Dec 2018
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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- J P Lecoq
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, J P Lecoq, University of Liege
- Investigators
- Annis Orfi, Principal investigator, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03696095
- Sponsor's protocol ID
- 2018-000822-70
- Other IDs
- 2018
- Status last verified
- Jan 2019
- First submitted
- 28 Sep 2018
- Last updated
- 25 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Infusion vs. Programmed Intermittent Bolus of Ropivacaine Through Peri-neural Femoral Nerve Catheter After Total Knee Arthroplasty: Impact on Analgesia Quality and Motor Block Frequency.
- ClinicalTrials.gov ID
- NCT03696095
- Acronym / sponsor ID
- 2018-000822-70
- Conditions
- Postoperative Pain, Postoperative Complications
- Keywords
- total knee arthroplasty, postoperative pain, programmed intermittent bolus, Continuous femoral nerve block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- J P LecoqUniversity, hospital or other
- Study start
- 16 Apr 2018 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 6 Dec 2018 (actual)
- First posted
- 4 Oct 2018 (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.
This study evaluates the impact of local anesthetic administration regiment through peri-neural femoral nerve catheter on pain and motor block frequency, after total knee arthroplasty.
Detailed description
This study evaluates the impact of local anesthetic administration regiment through peri-neural femoral nerve catheter on pain and motor block frequency, after total knee arthroplasty. One group of patients will receive automated intermittent bolus, while the others will get a continuous infusion. In both cases, patients will be able to administer supplementary auto-bolus if required.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continous infusion ropivacaine | Active comparator | Drug: Ropivacaine Hcl 0.2% Inj Bag 200Ml (CI mode)Continuous infusion via peri-neural femoral nerve catheter of Ropivacaine Hcl 0.2% Inj Bag 200Ml (CI mode) at rate of 6ml/h + patient controlled bolus of 3ml ... |
| PIB ropivacaine | Experimental | Drug: Ropivacaine Hcl 0.2% Inj Bag 200Ml (PIB mode)Programmed intermittent bolus of Ropivacaine Hcl 0.2% Inj Bag 200Ml (PIB mode) : 6ml each 60min + patient controlled bolus 3ml ... |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- admitted for unilateral primary total knee arthroplasty.
Key exclusion criteria (9 listed)
- ASA score > 3
- BMI > 40
- refusal of loco-regional technique.
- psychiatric disease.
- inability to understand/ use the Local anesthetic delivery pump.
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 Hcl 0.2% Inj Bag 200Ml (PIB mode)Also: PIBprogrammed intermittent bolus 5ml each one hour. | Drug | PIB ropivacaine |
| Ropivacaine Hcl 0.2% Inj Bag 200Ml (CI mode)Also: Continuous infusioncontinuous infusion 6ml/h | Drug | Continous infusion ropivacaine |
Primary outcome
Frequency of unplanned analgesia interventions.
Time frame: up to 72 hours after surgery
Composite criteria including the frequency of unplanned analgesia interventions administered by the patient, or paramedical and medical staff, and by extenstion the total amount of opioids (in milligrams equivalent morphine) and local anesthetics (in milligrams) received in post-operative period.
4 secondary outcomes
Pain difference
Time frame: up to 72 hours after surgery
Motor block frequency
Time frame: up to 72 hours after surgery
Mobilization quality during physiotherapy sessions.
Time frame: up to 72 hours after surgery
local anesthesia technique related complications
Time frame: until catheter removal 48 hours 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 25 Jan 2019.
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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.
Annis Orfi principal investigator
University of Liege
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 Hcl 0.2% Inj Bag 200Ml (PIB mode) and Ropivacaine Hcl 0.2% Inj Bag 200Ml (CI mode) in people with Postoperative Pain and Postoperative Complications, run by J P Lecoq at 1 site in Belgium.
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 1 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 25 Jan 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 Belgium. 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?
Frequency of unplanned analgesia interventions. (time frame: up to 72 hours after 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 25 Jan 2019.