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Completed

NCT Number: NCT03198403

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

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

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Key information

Conditions

Popliteal Plexus Block Total Knee Arthroplasty

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Silkeborg Regionalhospital

Silkeborg, 8600, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine-epinephrine

Drug

Popliteal plexus block with 10 mL of bupivacaine-epinephrine 5 mg/mL + 5 microgram/mL.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Regionshospitalet Silkeborg

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jun 26, 2017
Registry last updated
Sep 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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