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

NCT03353233 | Completed Phase 4 Results FDA Drug

• 1 other identifier: Pro00070573
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants Able to Hyperextend the Knee After Surgery

  Ability to hyperextend the knee after surgery

  Within 8 hours

Secondary Outcomes (3)

• Ambulation as Measured by Distance Walked After Surgery

  Post-operative Day 0

• Pain as Measure by Numerical Rating Scale (NRS) 11

  24 hours

• Cumulative Opioid Consumption

  24 hours

Study Arms (2)

iPACK Block Group

EXPERIMENTAL

A nerve block technique using a numbing medication called ropivacaine.

Drug: Ropivacaine; Procedure: Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block

Sham Group

PLACEBO COMPARATOR

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

Procedure: Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block; Drug: Saline

Interventions

Ropivacaine DRUG

Local anesthetic (numbing drug)

Also known as: Naropin

iPACK Block Group

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

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

Also known as: iPACK, Posterior Capsule

Sham Group; iPACK Block Group

Saline DRUG

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

Also known as: Salt water placebo

Sham Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Hospital

Durham, North Carolina, 27713, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain

Interventions

Ropivacaine; Dental Occlusion; Sodium Chloride

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

Technical problems with allocations leading to unrelabile and uninterpretable data.

Results Point of Contact

• Title: W. Michael Bullock, MD, PhD
• Organization: Duke University Medical Center

william.bullock@duke.edu

919-681-6437

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2017
• First Posted: November 27, 2017
• Study Start: May 3, 2018
• Primary Completion: January 22, 2021
• Study Completion: January 23, 2021
• Last Updated: December 21, 2021
• Results First Posted: December 21, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)