Evaluation of Utility of Ultrasound Guided iPACK Block for Knee Extension After Total Knee Arthroplasty.

NCT ID: NCT03353233

Last Updated: 2021-12-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-03
• Study Completion Date: 2021-01-23

Brief Summary

The purpose of this study is to learn if using an Interspace between the Popliteal Artery and Capsule of the Knee (iPACK) injection technique (also called a "nerve block") that numbs the nerves going to the back part of the knee to aid in physical therapy after surgery. The iPACK technique uses a numbing solution (local anesthetics) that is injected behind the knee to reduce pain and to help straighten the knee. This block may affect movement in the leg and make the legs weak, but thing is rare. A few institutions use the iPACK block for patients having total knee replacements, with the hope of providing good pain relief combined with improved mobility after surgery.

Conditions

Knee Osteoarthritis; Primary Total Knee Arthroplasty; Physical Therapy; Pain; Knee Extension

Keywords

iPACK; Interspace between the Popliteal Artery and Capsule of the Knee; Posterior Capsule block; Nerve Block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

iPACK Block Group

A nerve block technique using a numbing medication called ropivacaine.

Group Type: EXPERIMENTAL

Ropivacaine

Intervention Type: DRUG

Local anesthetic (numbing drug)

Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block

Intervention Type: PROCEDURE

An ultrasound guided nerve block using a numbing medication called ropivacaine that numbs the nerves to the back of the knee.

Sham Group

The same nerve block technique as above, however using an inactive solution of salt water.

Group Type: PLACEBO_COMPARATOR

Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block

Intervention Type: PROCEDURE

An ultrasound guided nerve block using a numbing medication called ropivacaine that numbs the nerves to the back of the knee.

Saline

Intervention Type: DRUG

An ultrasound guided nerve block using a medication that does NOT numb the nerve called saline, or salt water.

Interventions

Ropivacaine

Local anesthetic (numbing drug)

Intervention Type: DRUG

Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block

An ultrasound guided nerve block using a numbing medication called ropivacaine that numbs the nerves to the back of the knee.

Intervention Type: PROCEDURE

Saline

An ultrasound guided nerve block using a medication that does NOT numb the nerve called saline, or salt water.

Intervention Type: DRUG

Other Intervention Names

Naropin; iPACK; Posterior Capsule; Salt water placebo

Eligibility Criteria

Inclusion Criteria

• English speaking
• Between 18 and 75 years old
• American Society of Anesthesiologists (ASA) 1-3 patients undergoing primary total knee arthroplasty

Exclusion Criteria

• ASA 4 or 5
• Revision knee arthroplasty
• Diagnosis of chronic pain
• Daily chronic opioid use (over 3 months of continuous opioid use)
• Inability to communicate pain scores or need for analgesia
• Acute knee dislocation/fracture
• Infection at the site of block placement
• Age under 18 years old or greater than 75 years old
• Pregnant women
• Intolerance/allergy to local anesthetics
• Weight <50 kg
• Suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
• Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, may interfere with study assessments or compliance
• Current or historical evidence of any clinically significant disease or condition that, in the opinion of the investigator, may increase the risk of surgery or complicate the subject's postoperative course.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Duke University Hospital

Durham, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Pro00070573

Identifier Type: -

Identifier Source: org_study_id