Clinical trial NCT02701296: Posterior Capsular Injection With Femoral Nerve Block for Total Knee Arthroplasty
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posterior Knee Infiltration
Keywords: Infiltration between popliteal artery and capsule of knee (iPACK)
Lead sponsor: Trinity Health Of New England
Sponsor class: OTHER
First posted: 2016-03-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain Intensity
timeFrame: 48 hours post surgery
Secondary outcomes:
measure: Opioid Consumption
timeFrame: 24 hours post surgery
measure: Plantar Flexion in the Tibial Nerve Distribution
timeFrame: Upon emergence from anesthesia in the PACU
measure: Cold Sensation in the Tibial Nerve Distribution
timeFrame: Upon emergence from anesthesia in the PACU
measure: Dorsiflexion in the Peroneal Nerve Distribution
timeFrame: Upon emergence from anesthesia in the PACU
measure: Sensation in the Peroneal Nerve Distribution
timeFrame: Upon emergence from anesthesia in the PACU
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Saint Francis Hospital and Medical Center
state: Connecticut
Study officials:
affiliation: Saint Francis Hospital and Medical Center
name: Sanjay Sinha
role: PRINCIPAL_INVESTIGATOR
References: