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The Effect of Popliteal Plexus Block on Pain After Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT03198403
Recruitment Status : Completed
First Posted : June 26, 2017
Last Update Posted : September 29, 2017
Sponsor:
Information provided by (Responsible Party):
Charlotte Runge, Regionshospitalet Silkeborg

Brief Summary:
The study aims to investigate the effect of the Popliteal plexus block (PPB) on postoperative pain after total knee arthroplasty

Condition or disease Intervention/treatment Phase
Popliteal Plexus Block Total Knee Arthroplasty Drug: Bupivacaine-epinephrine Phase 4

Detailed Description:

Cadaver dissection studies have shown a spread of dye to the popliteal fossa and colored the popliteal plexus by injecting in the distal part of the adductor Canal.

The popliteal plexus is formed by contribution from the tibial and the obturator nerves.

Investigators hypothesized that a PPB may reduce postoperative pain after total knee arthroplasty.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Pilot Study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Popliteal Plexus Block on Postoperative Pain After Total Knee Arthroplasty
Actual Study Start Date : August 1, 2017
Actual Primary Completion Date : September 26, 2017
Actual Study Completion Date : September 28, 2017


Arm Intervention/treatment
Experimental: Popliteal plexus block
Patients with an FTB, reporting postoperative pain (NRS > 3) will have a popliteal plexus block
Drug: Bupivacaine-epinephrine
Popliteal plexus block with 10 mL of bupivacaine-epinephrine 5 mg/mL + 5 microgram/mL.

No Intervention: No intervention
Patients with postoperative pain NRS < or = 3



Primary Outcome Measures :
  1. The percentage of patients with postoperative pain NRS [ Time Frame: 0 - 60 minutes ]
    Evaluated as the percentage of patients with postoperative pain NRS >3, dropping in pain score to NRS = or < 3 after the PPB


Secondary Outcome Measures :
  1. Percentage of patients having a femoral triangle block(FTB) reporting NRS > 3 [ Time Frame: Pain scores every 15 minutes (from end injection FTB to NRS>3 or 3 hours after full sensation of the leg) ]
    Percentage of patients having a FTB, reporting postoperative pain NRS >3

  2. Onset time of PPB [ Time Frame: NRS every 5 minutes after PPB (From 0 - 60 minutes after PPB) ]
    Time from end of injection of PPB to NRS = or < 3

  3. Turn off time of spinal anesthesia [ Time Frame: Time from arrival in PACU and during maximum 6 hours ]
    Time from arrival in PACU to normal cutaneous sensation (measured by a neuro-pen, sensation=point 2) on the lateral part of the thigh and lateral part of the lower leg

  4. Correlation between normal cutaneous sensation and developing of pain [ Time Frame: From arrival in PACU and during maximum 6 hours ]
    Correlation between normal cutaneous sensation (measured by a neuro-pen, sensation=point 2) and developing of pain (NRS>3)

  5. The effect of the PPB on cutaneous sensation [ Time Frame: NRS every 5 minutes after PPB (From 0 - 60 minutes after PPB) ]
    Tested on the lateral part of the lower leg

  6. The effect of the PPB on muscle strength of the foot [ Time Frame: Baseline and 1 hour after PPB ]
    Dorsal flexion and plantar flexion in the ankle joint, measured with a handheld dynamometer



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients undergoing total knee arthroplasty in spinal anesthesia
  • age > or = 18 years
  • American Society of Anesthesiologists (ASA) status I-III
  • Informed consent

Exclusion Criteria:

  • Patients unable to cooperate
  • Patients not able to speak Danish
  • Pregnancy
  • Contraindication towards ana Medical product used in the study
  • Preoperatively reduced sensation on the medial and lateral part of the lower leg
  • Patients with diabetic requiring Medical treatment
  • Preoperative daily intake of opioids

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): NCT03198403


Locations
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Denmark
Silkeborg Regionalhospital
Silkeborg, Denmark, 8600
Sponsors and Collaborators
Regionshospitalet Silkeborg
Investigators
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Principal Investigator: Charlotte Runge, MD University of Aarhus

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Responsible Party: Charlotte Runge, Consultant anesthetist, Principal investigator, Regionshospitalet Silkeborg
ClinicalTrials.gov Identifier: NCT03198403     History of Changes
Other Study ID Numbers: 2017-001644-35
First Posted: June 26, 2017    Key Record Dates
Last Update Posted: September 29, 2017
Last Verified: September 2017

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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
Additional relevant MeSH terms:
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Epinephrine
Racepinephrine
Bupivacaine
Epinephryl borate
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