Pain, PostoperativePhase 4NCT03439787

Popliteal Plexus Block for Total Knee Arthroplasty

A Phase 4 study testing Bupivacaine-EPINEPHrine 0.5%-1:200,000 Injectable Solution and Sodium Chloride 0.9 % in people with Pain, Postoperative, run by University of Aarhus at 1 site in Denmark.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This study aims to assess the analgesic effect of the popliteal plexus block as a supplement to a femoral triangle block in patients undergoing total knee arthroplasty Read more about this study

Who is it for?: Ages 50 years and older
Conditions the study is for: Pain, Postoperative
What is being tested?: Bupivacaine-EPINEPHrine 0.5%-1:200,000 Injectable Solution and Sodium Chloride 0.9 %
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 15 participants
Where: 1 siteDenmark
Study dates: 15 May 2018to 23 Aug 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 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female at least 50 years of age at screening
Scheduled to undergo primary total knee arthroplasty in spinal anesthesia
Normal sensory function at the lateral part of the thigh and lower leg
American Society of Anesthesiologists (ASA) physical status 1, 2, or 3
Able to provide informed consent

Who cannot join

Unable to cooperate and follow the study protocol
Communication problems
Allergic towards any medical product administered in the study
Diabetes requiring medical treatment
Pregnancy (a pregnancy test will be conducted on all women of childbearing potential prior to inclusion in the study. A positive test result will result in exclusion from the study)
Preoperative opioid treatment (dosed > once daily)

Trial locations and contacts

1 site in 1 country.

Denmark1 site

Silkeborg Regional Hospital
Silkeborg, 8600

Other trials in Denmark

About this study

Official title: The Effect of the Popliteal Plexus Block on Postoperative Pain After Total Knee Arthroplasty - a Randomized, Controlled, Double-blinded Study

This study aims to assess the analgesic effect of the popliteal plexus block as a supplement to a femoral triangle block in patients undergoing total knee arthroplasty

Read the detailed description

A femoral triangle block (FTB) effectively anesthetizes the anterior group of nerves innervating the knee (infrapatellar branch of the saphenous nerve, the medial femoral cutaneous nerve and the terminal branch of the medial vastus muscle nerve). However, the posterior group of nerves innervating the knee joint is not covered with an FTB, and therefore most patients complain of significant, opioid-requiring pain despite a successful FTB.

The posterior group consists of the popliteal plexus, which is derived from the tibial nerve and the posterior branch of the obturator nerve. The popliteal plexus is located in the popliteal fossa, where it entwines the popliteal artery and vein. Recent cadaver studies have suggested that an injection into the distal part of the adductor canal will spread to the popliteal fossa (PubMed Identifier (ID): 28937534; PubMed ID: 27442773).

This study aims to assess the analgesic effect of the popliteal plexus block (PPB) as a supplement to a femoral triangle block (FTB) after total knee arthroplasty (TKA).

In the study all patients will receive an FTB with 10 ml bupivacaine-epinephrine (0.5%-1:200,000) with the addition of 0.5 ml Dexamethasone (4 mg/ml).

All patients are postoperatively observed for the development of significant pain (NRS > 3) in the primary observation period (POP) defined as: a 3-hour observation period starting at the return of completely normal cutaneous sensation (lateral thigh and lateral side of the lower leg) after spinal anesthesia. If the patient reports pain (NRS > 3) in the POP, the patient will be randomized to the study treatment - a PPB with 10 ml bupivacaine-epinephrine or 10 ml saline.

Conditions: Pain, Postoperative
Being tested: Bupivacaine-EPINEPHrine 0.5%-1:200,000 Injectable Solution, Sodium Chloride 0.9 %
Keywords: Arthroplasty, Replacement, Knee, Anesthetics, Local, Pain, Postoperative, Nerve Block, Bupivacaine, Epinephrine
Medical subject headings: Pain, Postoperative

What participants receive

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

Bupivacaine-EPINEPHrine 0.5%-1:200,000 Injectable SolutionDrug
Also called Marcain-adrenaline
10 ml
Sodium Chloride 0.9 %Other
10 ml

Study groups in NCT03439787
Study group	Role	What they receive
Active Popliteal Plexus Block	Active comparator	10 ml Bupivacaine-Epinephrine 0.5%-1:200,000 Injectable Solution Receives: Drug: Bupivacaine-EPINEPHrine 0.5%-1:200,000 Injectable Solution
Placebo Popliteal Plexus Block	Placebo comparator	10 ml Sodium Chloride 0.9 % Receives: Other: Sodium Chloride 0.9 %

What is being measured

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

Success of the popliteal plexus block (PPB)
Success of the PPB is defined as the proportion of patients with significant postoperative pain (NRS > 3) after FTB, who drop in pain score to NRS ≤ 3 after PPB and maintain NRS ≤ 3 without any opioids until 60 minutes after PPB
Measured: 60 minutes after placement of the PPB

Secondary outcomes (8)

Onset time of the PPB
The onset time is defined as the time from withdrawal of the block needle and until the patient reports NRS ≤ 3. The maximal onset time is defined as 60 minutes
Measured: The pain scores after PPB are evaluated every 5 minutes until 15 minutes after PPB and hereafter every 15 minutes until 60 minutes after PPB
The effect of the PPB on cutaneous sensation
Performed as a pinprick test on the lateral aspect of the lower leg. Sensation to pinprick is graded on a 3-point scale: 0 = no sensation, 1 = reduced sensation and 2 = normal sensation to pinprick compared to the contralateral side
Measured: Baseline and 2 hours after the placement of the PPB
The effect of PPB on isometric muscle strength of the he dorso- and plantar flexors of the ankle joint
Dorsal and plantar flexion of the foot is measured as the maximum voluntary isometric contraction (MVIC). During the test, a handheld dynamometer is kept immobile and the patient is asked to push against the dynamometer with maximal force and maintain this maximal pressure for 5 seconds. The MVIC is measured three times, separated by a 30-second pause, and the highest of the three MVIC values is registered
Measured: Baseline and 2 hours after the placement of the PPB
Opioid consumption from 0-4 hours
Registered from the electronic patient record
Measured: Subjects receiving PPB: From after PPB placement and up until 4 hours after PPB. Subjects not receiving PPB: From the end of the primary observation period (POP) and up until 4 hours after the end of the POP
Opioid consumption from 4-24 hours
Registered from the electronic patient record
Measured: Subjects receiving PPB: From 4 hours after PPB placement and up until 24 hours after PPB. Subjects not receiving PPB: From 4 hours after the end of the POP and up until 24 hours after the end of the POP
Pain scores (Numerical Rating Scale, NRS, 0-10 where 0 is "no pain" and 10 is "worst pain imaginable"
The patient is asked about the worst pain since last test time
Measured: For subjects receiving a PPB, pain scores will be performed 2, 4 and 24 hours after PPB. For subjects not receiving a PPB, final pain scores will be made at the 24 hrs follow-up visit
Pain localization
Evaluated using a systematic questionnaire
Measured: Subjects with NRS > 3: when significant pain is reported during the POP; 15 and 60 min after PPB; at any increase in NRS score at any time during the 60 min after PPB; 2, 4 and 24 hrs after PPB. For subjects with NRS ≤ 3: at the 24 hrs follow-up visit
The number of patients requiring a PPB
The number of patients experiencing NRS > 3 as a proportion of all patients with femoral triangle block (FTB)
Measured: All patients receive an FTB and are observed postoperatively for the development of NRS > 3 during the primary observation period (POP) defined as: A 3-hour observation period starting at the return of normal cutaneous sensation after spinal anesthesia

Timeline

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

15 May 201823 Aug 2018

First posted20 Feb 2018
Study start15 May 2018
Primary completion23 Aug 2018
Study completion23 Aug 2018

Why it stopped: Methodological problems/problems in the study design (competing pain and a placebo effect). No serious adverse events or other safety issues

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)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 of AarhusThe 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Randomized, placebo-controlled, double-blinded design
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03439787
Sponsor's protocol ID: Protocol_PPB_TKA_31122017
Other IDs: 2017-005180-40, 2017
Status last verified: Aug 2018
First submitted: 18 Jan 2018
Last updated: 25 Apr 2019
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Bendtsen TF, Moriggl B, Chan V, Borglum J. The Optimal Analgesic Block for Total Knee Arthroplasty. Reg Anesth Pain Med. 2016 Nov/Dec;41(6):711-719. doi: 10.1097/AAP.0000000000000485.
PubMed 27685346
Wong WY, Bjorn S, Strid JM, Borglum J, Bendtsen TF. Defining the Location of the Adductor Canal Using Ultrasound. Reg Anesth Pain Med. 2017 Mar/Apr;42(2):241-245. doi: 10.1097/AAP.0000000000000539.
PubMed 28002228
GARDNER E. The innervation of the knee joint. Anat Rec. 1948 May;101(1):109-30. doi: 10.1002/ar.1091010111. No abstract available.
PubMed 18915634
Abdallah FW, Chan VW, Gandhi R, Koshkin A, Abbas S, Brull R. The analgesic effects of proximal, distal, or no sciatic nerve block on posterior knee pain after total knee arthroplasty: a double-blind placebo-controlled randomized trial. Anesthesiology. 2014 Dec;121(6):1302-10. doi: 10.1097/ALN.0000000000000406.
PubMed 25099748
Abdallah FW, Madjdpour C, Brull R. Is sciatic nerve block advantageous when combined with femoral nerve block for postoperative analgesia following total knee arthroplasty? a meta-analysis. Can J Anaesth. 2016 May;63(5):552-68. doi: 10.1007/s12630-016-0613-2. Epub 2016 Feb 19.
PubMed 26896282
Runge C, Borglum J, Jensen JM, Kobborg T, Pedersen A, Sandberg J, Mikkelsen LR, Vase M, Bendtsen TF. The Analgesic Effect of Obturator Nerve Block Added to a Femoral Triangle Block After Total Knee Arthroplasty: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Jul-Aug;41(4):445-51. doi: 10.1097/AAP.0000000000000406.
PubMed 27171822
McNamee DA, Parks L, Milligan KR. Post-operative analgesia following total knee replacement: an evaluation of the addition of an obturator nerve block to combined femoral and sciatic nerve block. Acta Anaesthesiol Scand. 2002 Jan;46(1):95-9. doi: 10.1034/j.1399-6576.2002.460117.x.
PubMed 11903080
Taha AM. Brief reports: ultrasound-guided obturator nerve block: a proximal interfascial technique. Anesth Analg. 2012 Jan;114(1):236-9. doi: 10.1213/ANE.0b013e318237fb40. Epub 2011 Oct 24.
PubMed 22025494
Goffin P, Lecoq JP, Ninane V, Brichant JF, Sala-Blanch X, Gautier PE, Bonnet P, Carlier A, Hadzic A. Interfascial Spread of Injectate After Adductor Canal Injection in Fresh Human Cadavers. Anesth Analg. 2016 Aug;123(2):501-3. doi: 10.1213/ANE.0000000000001441.
PubMed 27442773
Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.
PubMed 18929686
Runge C, Moriggl B, Borglum J, Bendtsen TF. The Spread of Ultrasound-Guided Injectate From the Adductor Canal to the Genicular Branch of the Posterior Obturator Nerve and the Popliteal Plexus: A Cadaveric Study. Reg Anesth Pain Med. 2017 Nov/Dec;42(6):725-730. doi: 10.1097/AAP.0000000000000675.
PubMed 28937534

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?

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Study at a glance

From the registry record, last updated by the sponsor on 25 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of the Popliteal Plexus Block on Postoperative Pain After Total Knee Arthroplasty - a Randomized, Controlled, Double-blinded Study
ClinicalTrials.gov ID: NCT03439787
Acronym / sponsor ID: Protocol_PPB_TKA_31122017
Conditions: Pain, Postoperative
Keywords: Arthroplasty, Replacement, Knee, Anesthetics, Local, Pain, Postoperative, Nerve Block, Bupivacaine, Epinephrine
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Methodological problems/problems in the study design (competing pain and a placebo effect). No serious adverse events or other safety issues
Enrolment: 15 participants (actual)
Lead sponsor: University of AarhusUniversity, hospital or other
Study start: 15 May 2018 (actual)
Primary completion: 23 Aug 2018 (actual)
Study completion: 23 Aug 2018 (actual)
First posted: 20 Feb 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 aims to assess the analgesic effect of the popliteal plexus block as a supplement to a femoral triangle block in patients undergoing total knee arthroplasty

Detailed description

This study aims to assess the analgesic effect of the popliteal plexus block (PPB) as a supplement to a femoral triangle block (FTB) after total knee arthroplasty (TKA).

In the study all patients will receive an FTB with 10 ml bupivacaine-epinephrine (0.5%-1:200,000) with the addition of 0.5 ml Dexamethasone (4 mg/ml).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Randomized, placebo-controlled, double-blinded design

Arm	Type	Receives
Active Popliteal Plexus Block	Active comparator	Drug: Bupivacaine-EPINEPHrine 0.5%-1:200,000 Injectable Solution10 ml Bupivacaine-Epinephrine 0.5%-1:200,000 Injectable Solution
Placebo Popliteal Plexus Block	Placebo comparator	Other: Sodium Chloride 0.9 %10 ml Sodium Chloride 0.9 %

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Male or female at least 50 years of age at screening
Scheduled to undergo primary total knee arthroplasty in spinal anesthesia
Normal sensory function at the lateral part of the thigh and lower leg
American Society of Anesthesiologists (ASA) physical status 1, 2, or 3
Able to provide informed consent

Key exclusion criteria (6 listed)

Unable to cooperate and follow the study protocol
Communication problems
Allergic towards any medical product administered in the study
Diabetes requiring medical treatment
Pregnancy (a pregnancy test will be conducted on all women of childbearing potential prior to inclusion in the study. A positive test result will result in exclusion from the study)

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
Bupivacaine-EPINEPHrine 0.5%-1:200,000 Injectable SolutionAlso: Marcain-adrenaline10 ml	Drug	Active Popliteal Plexus Block
Sodium Chloride 0.9 %10 ml	Other	Placebo Popliteal Plexus Block

Primary outcome

Success of the popliteal plexus block (PPB)
Time frame: 60 minutes after placement of the PPB
Success of the PPB is defined as the proportion of patients with significant postoperative pain (NRS > 3) after FTB, who drop in pain score to NRS ≤ 3 after PPB and maintain NRS ≤ 3 without any opioids until 60 minutes after PPB

8 secondary outcomes

Onset time of the PPB
Time frame: The pain scores after PPB are evaluated every 5 minutes until 15 minutes after PPB and hereafter every 15 minutes until 60 minutes after PPB
The effect of the PPB on cutaneous sensation
Time frame: Baseline and 2 hours after the placement of the PPB
The effect of PPB on isometric muscle strength of the he dorso- and plantar flexors of the ankle joint
Time frame: Baseline and 2 hours after the placement of the PPB
Opioid consumption from 0-4 hours
Time frame: Subjects receiving PPB: From after PPB placement and up until 4 hours after PPB. Subjects not receiving PPB: From the end of the primary observation period (POP) and up until 4 hours after the end of the POP
Opioid consumption from 4-24 hours
Time frame: Subjects receiving PPB: From 4 hours after PPB placement and up until 24 hours after PPB. Subjects not receiving PPB: From 4 hours after the end of the POP and up until 24 hours after the end of the POP
Pain scores (Numerical Rating Scale, NRS, 0-10 where 0 is "no pain" and 10 is "worst pain imaginable"
Time frame: For subjects receiving a PPB, pain scores will be performed 2, 4 and 24 hours after PPB. For subjects not receiving a PPB, final pain scores will be made at the 24 hrs follow-up visit
Pain localization
Time frame: Subjects with NRS > 3: when significant pain is reported during the POP; 15 and 60 min after PPB; at any increase in NRS score at any time during the 60 min after PPB; 2, 4 and 24 hrs after PPB. For subjects with NRS ≤ 3: at the 24 hrs follow-up visit
The number of patients requiring a PPB
Time frame: All patients receive an FTB and are observed postoperatively for the development of NRS > 3 during the primary observation period (POP) defined as: A 3-hour observation period starting at the return of normal cutaneous sensation after spinal anesthesia

Results and safety

The study was stopped early (reason given: Methodological problems/problems in the study design (competing pain and a placebo effect). No serious adverse events or other safety issues). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2019.
Background: PubMed 27685346Bendtsen TF, Moriggl B, Chan V, Borglum J. The Optimal Analgesic Block for Total Knee Arthroplasty. Reg Anesth Pain Med. 2016 Nov/Dec;41(6):711-719. doi: 10.1097/AAP.0000000000000485.
Background: PubMed 28002228Wong WY, Bjorn S, Strid JM, Borglum J, Bendtsen TF. Defining the Location of the Adductor Canal Using Ultrasound. Reg Anesth Pain Med. 2017 Mar/Apr;42(2):241-245. doi: 10.1097/AAP.0000000000000539.
Background: PubMed 18915634GARDNER E. The innervation of the knee joint. Anat Rec. 1948 May;101(1):109-30. doi: 10.1002/ar.1091010111. No abstract available.
Background: PubMed 25099748Abdallah FW, Chan VW, Gandhi R, Koshkin A, Abbas S, Brull R. The analgesic effects of proximal, distal, or no sciatic nerve block on posterior knee pain after total knee arthroplasty: a double-blind placebo-controlled randomized trial. Anesthesiology. 2014 Dec;121(6):1302-10. doi: 10.1097/ALN.0000000000000406.
Background: PubMed 26896282Abdallah FW, Madjdpour C, Brull R. Is sciatic nerve block advantageous when combined with femoral nerve block for postoperative analgesia following total knee arthroplasty? a meta-analysis. Can J Anaesth. 2016 May;63(5):552-68. doi: 10.1007/s12630-016-0613-2. Epub 2016 Feb 19.
Background: PubMed 27171822Runge C, Borglum J, Jensen JM, Kobborg T, Pedersen A, Sandberg J, Mikkelsen LR, Vase M, Bendtsen TF. The Analgesic Effect of Obturator Nerve Block Added to a Femoral Triangle Block After Total Knee Arthroplasty: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Jul-Aug;41(4):445-51. doi: 10.1097/AAP.0000000000000406.
Background: PubMed 11903080McNamee DA, Parks L, Milligan KR. Post-operative analgesia following total knee replacement: an evaluation of the addition of an obturator nerve block to combined femoral and sciatic nerve block. Acta Anaesthesiol Scand. 2002 Jan;46(1):95-9. doi: 10.1034/j.1399-6576.2002.460117.x.
Background: PubMed 22025494Taha AM. Brief reports: ultrasound-guided obturator nerve block: a proximal interfascial technique. Anesth Analg. 2012 Jan;114(1):236-9. doi: 10.1213/ANE.0b013e318237fb40. Epub 2011 Oct 24.
Background: PubMed 27442773Goffin P, Lecoq JP, Ninane V, Brichant JF, Sala-Blanch X, Gautier PE, Bonnet P, Carlier A, Hadzic A. Interfascial Spread of Injectate After Adductor Canal Injection in Fresh Human Cadavers. Anesth Analg. 2016 Aug;123(2):501-3. doi: 10.1213/ANE.0000000000001441.
Background: PubMed 18929686Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.
Background: PubMed 28937534Runge C, Moriggl B, Borglum J, Bendtsen TF. The Spread of Ultrasound-Guided Injectate From the Adductor Canal to the Genicular Branch of the Posterior Obturator Nerve and the Popliteal Plexus: A Cadaveric Study. Reg Anesth Pain Med. 2017 Nov/Dec;42(6):725-730. doi: 10.1097/AAP.0000000000000675.
The pilot study on which the current study is basedLink provided by the sponsor.
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.

Charlotte R Sørensen, MD principal investigator

Silkeborg Regional Hospital

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 Bupivacaine-EPINEPHrine 0.5%-1:200,000 Injectable Solution and Sodium Chloride 0.9 % in people with Pain, Postoperative, run by University of Aarhus 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 5 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: stopped early, as of the sponsor's last update on 25 Apr 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. Some participants in this study may receive a placebo. 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?

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?

Success of the popliteal plexus block (PPB) (time frame: 60 minutes after placement of the PPB). 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 NCT03439787, which also lists 11 linked publications.

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 Apr 2019.