Posterior Capsular Injection With Femoral Nerve Block for Total Knee Arthroplasty

NCT ID: NCT02701296

Last Updated: 2018-10-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-07

Study Completion Date

2014-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Posterior Knee Infiltration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Posterior capsular injection

Ultrasound guided posterior capsular injection of ropivacaine with epinephrine

Group Type EXPERIMENTAL

Ropivacaine with Epinephrine

Intervention Type DRUG

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

Tibial nerve block

Ultrasound selective tibial nerve block of ropivacaine

Group Type ACTIVE_COMPARATOR

Ropivacaine

Intervention Type DRUG

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

Interventions

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Ropivacaine with Epinephrine

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

Intervention Type DRUG

Ropivacaine

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

Intervention Type DRUG

Other Intervention Names

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Naropin Adrenalin Naropin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Trinity Health Of New England

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sanjay Sinha

Role: PRINCIPAL_INVESTIGATOR

Saint Francis Hospital and Medical Center

Locations

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Saint Francis Hospital and Medical Center

Hartford, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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11-10-004

Identifier Type: -

Identifier Source: org_study_id

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