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Popliteal Plexus Block for Total Knee Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03439787
Recruitment Status : Terminated (Methodological problems/problems in the study design (competing pain and a placebo effect). No serious adverse events or other safety issues)
First Posted : February 20, 2018
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Brief 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

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: Bupivacaine-EPINEPHrine 0.5%-1:200,000 Injectable Solution Other: Sodium Chloride 0.9 % Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, placebo-controlled, double-blinded design
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of the Popliteal Plexus Block on Postoperative Pain After Total Knee Arthroplasty - a Randomized, Controlled, Double-blinded Study
Actual Study Start Date : May 15, 2018
Actual Primary Completion Date : August 23, 2018
Actual Study Completion Date : August 23, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Active Comparator: Active Popliteal Plexus Block
10 ml Bupivacaine-Epinephrine 0.5%-1:200,000 Injectable Solution
Drug: Bupivacaine-EPINEPHrine 0.5%-1:200,000 Injectable Solution
10 ml
Other Name: Marcain-adrenaline

Placebo Comparator: Placebo Popliteal Plexus Block
10 ml Sodium Chloride 0.9 %
Other: Sodium Chloride 0.9 %
10 ml




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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 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

  2. The effect of the PPB on cutaneous sensation [ Time Frame: Baseline and 2 hours after the placement of the PPB ]
    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

  3. 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 ]
    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

  4. 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 ]
    Registered from the electronic patient record

  5. 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 ]
    Registered from the electronic patient record

  6. 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 ]
    The patient is asked about the worst pain since last test time

  7. 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 ]
    Evaluated using a systematic questionnaire

  8. 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 ]
    The number of patients experiencing NRS > 3 as a proportion of all patients with femoral triangle block (FTB)



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03439787


Locations
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Denmark
Silkeborg Regional Hospital
Silkeborg, Denmark, 8600
Sponsors and Collaborators
University of Aarhus
Investigators
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Principal Investigator: Charlotte R Sørensen, MD Silkeborg Regional Hospital
Additional Information:
Publications:

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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT03439787    
Other Study ID Numbers: Protocol_PPB_TKA_31122017
2017-005180-40 ( EudraCT Number )
First Posted: February 20, 2018    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of Aarhus:
Arthroplasty, Replacement, Knee
Anesthetics, Local
Pain, Postoperative
Nerve Block
Bupivacaine
Epinephrine
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Epinephrine
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents