Posterior Capsular Injection With Femoral Nerve Block for Total Knee Arthroplasty

October 2, 2018 updated by: Saint Francis Care

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Hartford, Connecticut, United States, 06105
        • Saint Francis Hospital and Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Posterior capsular injection
Ultrasound guided posterior capsular injection of ropivacaine with epinephrine
Drug: Ropivacaine with Epinephrine
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
Active Comparator: Tibial nerve block
Ultrasound selective tibial nerve block of ropivacaine
Drug: Ropivacaine
Tibial nerve block - ultrasound selective Ropivacaine tibial nerve block in the popliteal fossa
Other Names:
  • Naropin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
48 hours post surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid Consumption
Time Frame: 24 hours post surgery
Amount of opioid used for the first 24 hours post surgery
24 hours post surgery
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)
Upon emergence from anesthesia in the PACU
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)
Upon emergence from anesthesia in the PACU
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)
Upon emergence from anesthesia in the PACU
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)
Upon emergence from anesthesia in the PACU

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saint Francis Care

Investigators

  • Principal Investigator: Sanjay Sinha, Saint Francis Hospital and Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 2011

Primary Completion (Actual)

August 31, 2014

Study Completion (Actual)

August 31, 2014

Study Registration Dates

First Submitted

February 17, 2016

First Submitted That Met QC Criteria

March 2, 2016

First Posted (Estimate)

March 8, 2016

Study Record Updates

Last Update Posted (Actual)

October 3, 2018

Last Update Submitted That Met QC Criteria

October 2, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-10-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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