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OpenTrials
Completed

NCT Number: NCT02701296

Posterior Capsular Injection With Femoral Nerve Block for Total Knee Arthroplasty

To assess pain control after total knee replacement surgery using two different nerve block techniques. The 2 methods are:

1. Continuous femoral nerve block with ultrasound guided posterior capsular injection 2. Continuous femoral nerve block with ultrasound selective tibial nerve block.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saint Francis Hospital and Medical Center

Hartford, Connecticut, 06105, United States

About this study

Patients undergoing total knee replacement surgery experience severe post-operative pain. Continuous femoral nerve block combined with selective tibial nerve block provides optimal pain control in the anterior and posterior aspect of the knee respectively. However, in patients with pre-existing neuropathy of the sciatic nerve, the blockade of tibial nerve is contraindicated because of increased risk of nerve damage that may lead to exacerbation of neurologic symptoms. In such patients where selective tibial nerve block cannot be offered, ultrasound guided posterior knee capsular injection may be an alternative technique for controlling posterior knee pain after surgery. Posterior capsular injection by surgeons intraoperatively, when combined with femoral nerve block has been shown to provide pain control after total knee replacement. With posterior capsular injection, the main trunk of the tibial nerve is spared and only the terminal nerve endings innervating the posterior knee joint is blocked providing effective pain control. In this study, the efficacy of ultrasound guided posterior capsular injections performed pre-operatively will be compared to tibial nerve block in controlling knee pain after surgery.

The results of this study may help establish the efficacy of ultrasound guided posterior capsular injection as an alternative to tibial nerve block in patients undergoing total knee arthroplasty.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients having primary, unilateral total knee arthroplasty
  • Age 18-80

Exclusion criteria

  • History of neurologic disease, neuropathy, diabetes, or major systemic illness
  • Allergy to local anesthetic solution or NSAIDs
  • Pregnancy
  • Chronic use of narcotics
  • Inability to give consent/cooperate with study

Treatment and study plan

Ropivacaine with Epinephrine

Drug

Posterior capsular injection - ultrasound guided infiltration of Ropivacaine with Epinephrine between popliteal artery and capsule of knee above the femoral condyles

Other names: Naropin, Adrenalin

Ropivacaine

Drug

Tibial nerve block - ultrasound selective Ropivacaine tibial nerve block in the popliteal fossa

Other names: Naropin

Primary outcomes

  1. Pain Intensity

    Time frame: 48 hours post surgery

    Mean Numeric Pain Rating Scale (NPRS) self-reported pain Intensity on a 11-point score (0=no pain to 10= worst possible) in Post Anesthesia Care Unit (PACU) and every 6 hours for 48 hours post surgery

Secondary outcomes

  1. Opioid Consumption

    Time frame: 24 hours post surgery

    Amount of opioid used for the first 24 hours post surgery

  2. Plantar Flexion in the Tibial Nerve Distribution

    Time frame: Upon emergence from anesthesia in the PACU

    Blinded nurse assessment on a 3-point scale 0= normal (No Motor Block), 1= weak (Partial Motor Block), 2 = absent (Complete Motor Block)

  3. Cold Sensation in the Tibial Nerve Distribution

    Time frame: Upon emergence from anesthesia in the PACU

    Number of participants with a self reported on a 3-point scale; 0=normal (No Sensory Block), 1= absent cold perception but touch sensation in tact (Partial Sensory Block), 2= absence of touch sensation (Complete Sensory Block)

  4. Dorsiflexion in the Peroneal Nerve Distribution

    Time frame: Upon emergence from anesthesia in the PACU

    Number of participants with a blinded nurse assessment on a 3-point scale 0= normal (No Motor Block), 1= weak (Partial Motor Block), 2 = absent (Complete Motor Block)

  5. Sensation in the Peroneal Nerve Distribution

    Time frame: Upon emergence from anesthesia in the PACU

    Number of participants with self reported on a 3-point scale; 0=normal (No Sensory Block), 1= absent cold perception but touch sensation in tact (Partial Sensory Block), 2= absence of touch sensation (Complete Sensory Block)

Sponsors and collaborators

Lead sponsor

Trinity Health Of New England

Other

Registry information

Official study title

Assessment of Knee Pain in Patients Receiving Continuous Femoral Nerve Block Combined With Either Ultrasound Guided Posterior Capsular Injection or Selective Tibial Nerve Block Following Total Knee Arthroplasty

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Mar 8, 2016
Registry last updated
Oct 3, 2018

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.