Posterior Capsular Injection With Femoral Nerve Block for Total Knee Arthroplasty

NCT02701296 | Completed Results

• 1 other identifier: 11-10-004
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Conditions

Posterior Knee Infiltration

Keywords

Infiltration between popliteal artery and capsule of knee (iPACK)

Outcome Measures

Primary Outcomes (1)

• Pain Intensity

  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 Outcomes (5)

• Opioid Consumption

  24 hours post surgery

• Plantar Flexion in the Tibial Nerve Distribution

  Upon emergence from anesthesia in the PACU

• Cold Sensation in the Tibial Nerve Distribution

  Upon emergence from anesthesia in the PACU

• Dorsiflexion in the Peroneal Nerve Distribution

  Upon emergence from anesthesia in the PACU

• Sensation in the Peroneal Nerve Distribution

  Upon emergence from anesthesia in the PACU

Study Arms (2)

Posterior capsular injection

EXPERIMENTAL

Ultrasound guided posterior capsular injection of ropivacaine with epinephrine

Drug: Ropivacaine with Epinephrine

Tibial nerve block

ACTIVE COMPARATOR

Ultrasound selective tibial nerve block of ropivacaine

Drug: Ropivacaine

Interventions

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

Also known as: Naropin, Adrenalin

Posterior capsular injection

Ropivacaine DRUG

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

Also known as: Naropin

Tibial nerve block

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Trinity Health Of New England: lead

Study Sites (1)

Saint Francis Hospital and Medical Center

Hartford, Connecticut, 06105, United States

Location

MeSH Terms

Interventions

Ropivacaine; Epinephrine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Sanjay Sinha, MD
• Organization: ST. FRANCIS HOSPITAL AND MEDICAL CENTER

sanjaysinha@comcast.net

Study Officials

• Sanjay Sinha

  Saint Francis Hospital and Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2016
• First Posted: March 8, 2016
• Study Start: November 7, 2011
• Primary Completion: August 31, 2014
• Study Completion: August 31, 2014
• Last Updated: October 3, 2018
• Results First Posted: June 14, 2017

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)