PainPhase 4PGENECANCT04681547

Ultrasound-guided Genicular Nerve Block for Total Knee Arthroplasty.

A Phase 4 study testing Genicular nerve Block and Local Infiltration Analgesia in people with Pain, run by Hospital Clinic of Barcelona at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The hypothesis is to demonstrate the analgesic non-inferiority of the ultrasound-guided geniculate nerve block when compared to the local infiltration analgesia (LIA). It is expected to maintain the quality of analgesia with a selective blockade of the nerves responsible for the sensitive innervation of the knee… Read more about this study

Who is it for?: Ages 18 to 90 years
Conditions the study is for: Pain
What is being tested?: Genicular nerve Block and Local Infiltration Analgesia
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteSpain
Study dates: 15 Dec 2020to 30 Apr 2021
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 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects scheduled for primary elective total knee arthroplasty
American Society of Anesthesiologists Physical Status I-III
BMI 18-40 kg/m2

Who cannot join

Inability to cooperate with protocol
Allergy to any medication of protocol
Contraindication to peripheral nerve block (e.g. local or systemic infection, neurologic deficit or disorder, previous trauma or surgery to ipsilateral knee, etc.)
Revision or prothesis replacement knee surgery
Chronic opioid consumption (daily morphine equivalent of >30 mg for at least four weeks prior to surgery)
Bleeding diathesis or non-pharmacological coagulopathy

Trial locations and contacts

1 site in 1 country.

Spain1 site

Hospital Clínic de Barcelona
Barcelona, 08036

Other trials in Spain

About this study

Official title: Ultrasound-guided Genicular Nerve Block: An Analgesic Alternative to LIA for Total Knee Arthroplasty.

Read the detailed description

The main objective is to demonstrate that the ultrasound-guided geniculate nerve block provides not-inferior analgesia to LIA in patients undergoing primary total knee arthroplasty (TKA) in the first 24 hours postoperatively, and during the first mobilization using the numerical evaluation of the pain (NRS).

The secondary objectives are to demonstrate that the consumption of opioids and the range of joint mobility are not inferior in those patients who receive geniculate nerve blocks compared to those who receive LIA.

Conditions: Pain
Being tested: Genicular nerve Block, Local Infiltration Analgesia
Keywords: Pain, Analgesia, LIA, Ultrasound, Genicular Nerve Block
Medical subject headings: Pain, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Genicular nerve BlockProcedure or surgery
After the administration of spinal anesthesia, the anatomical structures of the proximal and distal region of the knee will be explored through an M- ultrasound machine Turbo® with a high-frequency 6-13 MHz linear probe.
The ultrasound transducer will be placed in a coronal orientation to the axis of the knee in the corresponding area to be blocked according to anatomical landmarks of superior medial genicular nerve (SMGN), inferior medial genicular nerve block (IMGN), superior lateral genicular nerve (SLGN), inferior lateral genicular nerve (ILGN), and recurrent genicular nerve (RGN).
It should be noted that the visualization of the genicular arteries in the femoral epicondyles and in the area of the tibial plateau, represents an accurate guide to where the sensory afferents are, however; its display is not constant.
4 ml of 0.2% ropivacaine will be administered, with adrenaline 1: 100 000 in each of the five nerves.
Local Infiltration AnalgesiaProcedure or surgery
100 ml of ropivacaine 0.2% with 1 mg of epinephrine during the period of intraoperative ischemia and, before the closure of the surgical wound, 50 ml of ropivacaine 0.2%.

Study groups in NCT04681547
Study group	Role	What they receive
Genicular nerve block	Experimental	An ultrasound-assisted genicular nerve block will be performed. 4 ml of 0.2% ropivacaine will be administered, with adrenaline 1: 100 000 in each of the five nerves. Receives: Procedure: Genicular nerve Block
Local infiltration Analgesia	Active comparator	Administration of ropivacaine 0.2% 150 ml will be performed. Receives: Procedure: Local Infiltration Analgesia

What is being measured

The primary outcome is the main question the study is designed to answer.

NRS at PACU
NRS [Numerical Rating Scale, 0-11] at PACU [post-anaesthesia care unit] after spinal block reversal, evaluated as active contralateral knee genuflection at 90 degrees.
Measured: 1 hour after surgery
NRS at 12 hours after surgery
Pain will be assessed by NRS [Numerical Rating Scale, 0-11] by a ward nurse, blind for intraoperative analgesic treatment.
Measured: 12 hours
NRS at 24 hours after surgery
Pain will be assessed by NRS [Numerical Rating Scale, 0-11] by a ward nurse, blind for intraoperative analgesic treatment.
Measured: 24 hours
NRS after physiotherapy
It corresponds to day 1 after the surgical intervention and will be carried out in the hospitalization room by a physiotherapist. The NRS [Numerical Rating Scale, 0-11] will be recorded during the first examination and mobilization
Measured: 24 hours

Secondary outcomes (3)

Opioid consumption in the postoperative period
Opioid consumption in the postoperative period in oral morphine equivalents
Measured: until 24 hours
Knee mobility range
Minimal and maximal mobility range [degrees]
Measured: 24 hours
Quality of sleep
Quality of sleep of the first night using the quality of sleep visual analogue scale [0-100 mm]
Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Dec 202030 Apr 2021

First posted23 Dec 2020
Study start15 Dec 2020
Primary completion30 Apr 2021
Study completion30 Apr 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for PainStudies of the same condition, open and under way.
More trials run by Hospital Clinic of BarcelonaThe 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 4
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04681547
Sponsor's protocol ID: HCB/2019/1148
Other IDs: 2019-005010-19, 2019
Acronym: PGENECA
Status last verified: May 2021
First submitted: 15 Dec 2020
Last updated: 2 Jun 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ultrasound-guided Genicular Nerve Block: An Analgesic Alternative to LIA for Total Knee Arthroplasty.
ClinicalTrials.gov ID: NCT04681547
Acronym / sponsor ID: PGENECA / HCB/2019/1148
Conditions: Pain
Keywords: Pain, Analgesia, LIA, Ultrasound, Genicular Nerve Block
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Hospital Clinic of BarcelonaUniversity, hospital or other
Study start: 15 Dec 2020 (actual)
Primary completion: 30 Apr 2021 (actual)
Study completion: 30 Apr 2021 (actual)
First posted: 23 Dec 2020 (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.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Genicular nerve block	Experimental	Procedure: Genicular nerve BlockAn ultrasound-assisted genicular nerve block will be performed. 4 ml of 0.2% ropivacaine will be administered, with adrenaline 1: 100 000 in each of the five nerves.
Local infiltration Analgesia	Active comparator	Procedure: Local Infiltration AnalgesiaAdministration of ropivacaine 0.2% 150 ml will be performed.

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Subjects scheduled for primary elective total knee arthroplasty
American Society of Anesthesiologists Physical Status I-III
BMI 18-40 kg/m2

Key exclusion criteria (6 listed)

Inability to cooperate with protocol
Allergy to any medication of protocol
Contraindication to peripheral nerve block (e.g. local or systemic infection, neurologic deficit or disorder, previous trauma or surgery to ipsilateral knee, etc.)
Revision or prothesis replacement knee surgery
Chronic opioid consumption (daily morphine equivalent of >30 mg for at least four weeks prior to 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
Genicular nerve BlockAfter the administration of spinal anesthesia, the anatomical structures of the proximal and distal region of the knee will be explored through an M- ultrasound machine Turbo® with a high-frequency 6-13 MHz linear probe. The ultrasound transducer will be placed in a coronal orientation to the axis of the knee in the corresponding area to be blocked according to anatomical landmarks of superior medial genicular nerve (SMGN), inferior medial genicular nerve block (IMGN), superior lateral genicular nerve (SLGN), inferior lateral genicular nerve (ILGN), and recurrent genicular nerve (RGN). It should be noted that the visualization of the genicular arteries in the femoral epicondyles and in the area of the tibial plateau, represents an accurate guide to where the sensory afferents are, however; its display is not constant. 4 ml of 0.2% ropivacaine will be administered, with adrenaline 1: 100 000 in each of the five nerves.	Procedure or surgery	Genicular nerve block
Local Infiltration Analgesia100 ml of ropivacaine 0.2% with 1 mg of epinephrine during the period of intraoperative ischemia and, before the closure of the surgical wound, 50 ml of ropivacaine 0.2%.	Procedure or surgery	Local infiltration Analgesia

Primary outcome

NRS at PACU
Time frame: 1 hour after surgery
NRS [Numerical Rating Scale, 0-11] at PACU [post-anaesthesia care unit] after spinal block reversal, evaluated as active contralateral knee genuflection at 90 degrees.
NRS at 12 hours after surgery
Time frame: 12 hours
Pain will be assessed by NRS [Numerical Rating Scale, 0-11] by a ward nurse, blind for intraoperative analgesic treatment.
NRS at 24 hours after surgery
Time frame: 24 hours
Pain will be assessed by NRS [Numerical Rating Scale, 0-11] by a ward nurse, blind for intraoperative analgesic treatment.
NRS after physiotherapy
Time frame: 24 hours
It corresponds to day 1 after the surgical intervention and will be carried out in the hospitalization room by a physiotherapist. The NRS [Numerical Rating Scale, 0-11] will be recorded during the first examination and mobilization

3 secondary outcomes

Opioid consumption in the postoperative period
Time frame: until 24 hours
Knee mobility range
Time frame: 24 hours
Quality of sleep
Time frame: 24 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 2 Jun 2021.
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.

Tomás López, MD principal investigator

Hospital Clinic of Barcelona

Xavier Sala-Blanch, MD principal investigator

Hospital Clinic of Barcelona

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 Genicular nerve Block and Local Infiltration Analgesia in people with Pain, run by Hospital Clinic of Barcelona at 1 site in Spain.

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 2 Jun 2021. 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 Spain. 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?

NRS at PACU (time frame: 1 hour after surgery). The study lists 4 primary outcomes in all. 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 NCT04681547.

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 2 Jun 2021.