Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
15 participants
INTERVENTIONAL
2018-05-15
2018-08-23
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Active Popliteal Plexus Block
10 ml Bupivacaine-Epinephrine 0.5%-1:200,000 Injectable Solution
Bupivacaine-EPINEPHrine 0.5%-1:200,000 Injectable Solution
10 ml
Placebo Popliteal Plexus Block
10 ml Sodium Chloride 0.9 %
Sodium Chloride 0.9 %
10 ml
Interventions
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Bupivacaine-EPINEPHrine 0.5%-1:200,000 Injectable Solution
10 ml
Sodium Chloride 0.9 %
10 ml
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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)
50 Years
ALL
No
Sponsors
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University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Charlotte R Sørensen, MD
Role: PRINCIPAL_INVESTIGATOR
Silkeborg Regional Hospital
Locations
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Silkeborg Regional Hospital
Silkeborg, , Denmark
Countries
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References
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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.
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.
GARDNER E. The innervation of the knee joint. Anat Rec. 1948 May;101(1):109-30. doi: 10.1002/ar.1091010111. No abstract available.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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The pilot study on which the current study is based
Other Identifiers
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2017-005180-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
Protocol_PPB_TKA_31122017
Identifier Type: -
Identifier Source: org_study_id
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