Pain, PostoperativeNCT04048889
Addition of Popliteal Plexus Block to Continuous Femoral Nerve Block for Total Knee Arthroplasty
A study testing Ropivacaine 0.5% Injectable Solution in people with Pain, Postoperative, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
The popliteal plexus block has been described as an alternative analgesic postoperative pain treatment for total knee arthroplasty. It consists of injecting local anaeshetics inside the distal end of the adductor canal close to the adductor hiatus, adjacent to the femoral artery, between the medial vastus muscle and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Ropivacaine 0.5% Injectable Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteSwitzerland
- Study dates
- 22 Jul 2019to 1 Jul 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients scheduled for total knee athroplasty under general anesthesia
- ASA 1-3
Who cannot join
- Kidney disease with GFR < 50 ml/mn
- Daily opioid consumption > 1 month
- Allergy to local anesthetics
- Neurological problems of the lower extremity
- other contraindications to peripheral nerve blocks
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Departement of Anesthesia, Hôpitaux Universitaires de Genève
Geneva, 1205
Kevin Stebler, MD, 0041795532149, kevin.stebler@hcuge.ch
Roxane Fournier, PD, 0041795532058, roxabe.fournier@hcuge.ch
About this study
The popliteal plexus block has been described as an alternative analgesic postoperative pain treatment for total knee arthroplasty. It consists of injecting local anaeshetics inside the distal end of the adductor canal close to the adductor hiatus, adjacent to the femoral artery, between the medial vastus muscle and the adductor magnus muscle, in order to anesthetize the popliteal plexus. However, the analgesic efficacy has never been demonstrated in a randomized controlled trial. Therefore the objective of this study is to investigate the analgesic benefit of this block combined with a continuous femoral nerve block, on patients scheduled for total knee athroplasty.
Read the detailed description
Patients scheduled to undergo total knee arthroplasty under general anesthesia will be randomly allocated to two groups: continuous femoral nerve block alone or continuous femoral nerve block with addition of a popliteal plexus block.
The continuous femoral nerve block will be performed by the anesthesiologist with 15 mLs of ropivacaine 0.5%, under ultrasound guidance before the beginning of the general anesthesia. The popliteal plexus block will be done by the anesthesiology, under ultrasound guidance, before the beginning of the surgery, under general anesthesia.
Postoperative analgesia will include acetaminophen (4 x 1000 mg), ibuprofen (3 x 400 mg) and a continuous infusion of Ropivacaine 0.2%.
- Conditions
- Pain, Postoperative
- Being tested
- Ropivacaine 0.5% Injectable Solution
- 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 0.5% Injectable SolutionDrug
Also called Continous femoral nerve block
Continuous femoral nerve block with injection of 15 mls of Ropivacain 0.5% adjacent to the lateral aspect of the femoral nerve below the fascia iliaca and placement of the catheter within the vicinity of the femoral nerve, juste deep to the fascia iliaca
Ropivacaine 0.5% Injectable SolutionDrug
Also called Continous femoral nerve block
Continuous femoral nerve block with injection of 15 mls of Ropivacain 0.5% adjacent to the lateral aspect of the femoral nerve below the fascia iliaca and placement of the catheter within the vicinity of the femoral nerve, juste deep to the fascia iliaca.
Ropivacaine 0.5% Injectable SolutionDrug
Also called Popliteal plexus block
Popliteal plexus block with injection of 15 mls of Ropivacain 0.5% inside the distal end of the adductor canal close to the adductor hiatus, adjacent to the femoral artery, between the medial vastus muscle and the adductor Magnus muscle, done under general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Popliteal plexus block and continuous femoral nerve block | Experimental | Not described Receives: Drug: Ropivacaine 0.5% Injectable Solution |
| continuous femoral nerve block | Active comparator | Not described Receives: Drug: Ropivacaine 0.5% Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total iv morphine consumption (mg)
Measured: 12 postoperative hours
Secondary outcomes (7)
Total iv morphine consumption (mg)
Measured: 24 and 48 postoperative hours
Average and maximum pain scores (Numeric rating scale 0-10)
Measured: 12, 24 and 48 postoperative hours
Sciatic extension of popliteal plexus block
Presence of sensitive or/and motor sciatic extension of popliteal plexus block
Measured: 2 and 24 postoperative hours
Plantarflexion and dorsiflexion ankle strength (Newtons)
Measured: 2 and 24 postoperative hours
Knee pain localization (anterior, internal, posterior, lateral, medial)
Measured: 2, 12, 24 and 48 postoperative hours
Popliteal plexus block procedure time (minutes)
Onset of action = beginning of the disinfection; End of action = end of injection of 15 mls of Ropivacain 0.5%
Measured: When performing the popliteal plexus block
Popliteal plexus block duration of action (hours)
Onset of action = Time from end of infection of 15 mls of Ropivacain 0.5%; End of action = onset of lateral and/or posterior knee pain (With Numeric rating scale ≥ 4)
Measured: up to 48 postoperative hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2019
- Study start22 Jul 2019
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- 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
- Randomized controlled triple-blinded trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin Stebler, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04048889
- Sponsor's protocol ID
- 2019-00655
- Other IDs
- 2019
- Status last verified
- Aug 2019
- First submitted
- 27 Jul 2019
- Last updated
- 7 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Stebler K, Elia N, Zaccaria I, Fournier RM. Popliteal plexus block in total knee arthroplasty: a single-center randomized controlled double-blinded trial. Reg Anesth Pain Med. 2026 Mar 5;51(3):309-316. doi: 10.1136/rapm-2024-105782.
PubMed 39709189
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addition of Popliteal Plexus Block to Continuous Femoral Nerve Block for Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT04048889
- Acronym / sponsor ID
- 2019-00655
- Conditions
- Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 22 Jul 2019 (actual)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 7 Aug 2019 (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.
The popliteal plexus block has been described as an alternative analgesic postoperative pain treatment for total knee arthroplasty. It consists of injecting local anaeshetics inside the distal end of the adductor canal close to the adductor hiatus, adjacent to the femoral artery, between the medial vastus muscle and the adductor magnus muscle, in order to anesthetize the popliteal plexus. However, the analgesic efficacy has never been demonstrated in a randomized controlled trial. Therefore the objective of this study is to investigate the analgesic benefit of this block combined with a continuous femoral nerve block, on patients scheduled for total knee athroplasty.
Detailed description
Patients scheduled to undergo total knee arthroplasty under general anesthesia will be randomly allocated to two groups: continuous femoral nerve block alone or continuous femoral nerve block with addition of a popliteal plexus block.
The continuous femoral nerve block will be performed by the anesthesiologist with 15 mLs of ropivacaine 0.5%, under ultrasound guidance before the beginning of the general anesthesia. The popliteal plexus block will be done by the anesthesiology, under ultrasound guidance, before the beginning of the surgery, under general anesthesia.
Postoperative analgesia will include acetaminophen (4 x 1000 mg), ibuprofen (3 x 400 mg) and a continuous infusion of Ropivacaine 0.2%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled triple-blinded trial
| Arm | Type | Receives |
|---|---|---|
| Popliteal plexus block and continuous femoral nerve block | Experimental | Drug: Ropivacaine 0.5% Injectable Solution |
| continuous femoral nerve block | Active comparator | Drug: Ropivacaine 0.5% Injectable Solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients scheduled for total knee athroplasty under general anesthesia
- ASA 1-3
Key exclusion criteria (5 listed)
- Kidney disease with GFR < 50 ml/mn
- Daily opioid consumption > 1 month
- Allergy to local anesthetics
- Neurological problems of the lower extremity
- other contraindications to peripheral nerve blocks
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 0.5% Injectable SolutionAlso: Continous femoral nerve blockContinuous femoral nerve block with injection of 15 mls of Ropivacain 0.5% adjacent to the lateral aspect of the femoral nerve below the fascia iliaca and placement of the catheter within the vicinity of the femoral nerve, juste deep to the fascia iliaca | Drug | continuous femoral nerve block |
| Ropivacaine 0.5% Injectable SolutionAlso: Continous femoral nerve blockContinuous femoral nerve block with injection of 15 mls of Ropivacain 0.5% adjacent to the lateral aspect of the femoral nerve below the fascia iliaca and placement of the catheter within the vicinity of the femoral nerve, juste deep to the fascia iliaca. | Drug | Popliteal plexus block and continuous femoral nerve block |
| Ropivacaine 0.5% Injectable SolutionAlso: Popliteal plexus blockPopliteal plexus block with injection of 15 mls of Ropivacain 0.5% inside the distal end of the adductor canal close to the adductor hiatus, adjacent to the femoral artery, between the medial vastus muscle and the adductor Magnus muscle, done under general anesthesia. | Drug | Popliteal plexus block and continuous femoral nerve block |
Primary outcome
Total iv morphine consumption (mg)
Time frame: 12 postoperative hours
7 secondary outcomes
Total iv morphine consumption (mg)
Time frame: 24 and 48 postoperative hours
Average and maximum pain scores (Numeric rating scale 0-10)
Time frame: 12, 24 and 48 postoperative hours
Sciatic extension of popliteal plexus block
Time frame: 2 and 24 postoperative hours
Plantarflexion and dorsiflexion ankle strength (Newtons)
Time frame: 2 and 24 postoperative hours
Knee pain localization (anterior, internal, posterior, lateral, medial)
Time frame: 2, 12, 24 and 48 postoperative hours
Popliteal plexus block procedure time (minutes)
Time frame: When performing the popliteal plexus block
Popliteal plexus block duration of action (hours)
Time frame: up to 48 postoperative hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
- Derived from this study: PubMed 39709189Stebler K, Elia N, Zaccaria I, Fournier RM. Popliteal plexus block in total knee arthroplasty: a single-center randomized controlled double-blinded trial. Reg Anesth Pain Med. 2026 Mar 5;51(3):309-316. doi: 10.1136/rapm-2024-105782.
- 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.
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 0.5% Injectable Solution in people with Pain, Postoperative, run by University Hospital, Geneva at 1 site in Switzerland.
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 2 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: status not confirmed, as of the sponsor's last update on 7 Aug 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 Switzerland. 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 Kevin Stebler, MD (0041795532149, kevin.stebler@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total iv morphine consumption (mg) (time frame: 12 postoperative hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04048889, which also lists 1 linked publication.
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 7 Aug 2019.