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

• Sponsor: Duke University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03353233
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Actual Duration (Months): 32.7
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis; Primary Total Knee Arthroplasty; Physical Therapy; Pain; Knee Extension	Drug: Ropivacaine; Procedure: Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block; Drug: Saline	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Supportive Care
• Official Title: Evaluation of Utility of Ultrasound Guided iPACK Block for Knee Extension After Total Knee Arthroplasty.
• Actual Study Start Date: May 3, 2018
• Actual Primary Completion Date: Jan 22, 2021
• Actual Study Completion Date: Jan 23, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: iPACK Block Group A nerve block technique using a numbing medication called ropivacaine.	Drug: Ropivacaine; Local anesthetic (numbing drug); Other Names: Naropin ; Procedure: 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.; Other Names: iPACK Posterior Capsule
Placebo Comparator: Sham Group 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; An ultrasound guided nerve block using a numbing medication called ropivacaine that numbs the nerves to the back of the knee.; Other Names: iPACK Posterior Capsule ; Drug: Saline; An ultrasound guided nerve block using a medication that does NOT numb the nerve called saline, or salt water.; Other Names: Salt water placebo

Outcome Measures

Primary Outcome Measures

1. Number of Participants Able to Hyperextend the Knee After Surgery [Within 8 hours]

   Ability to hyperextend the knee after surgery

Secondary Outcome Measures

1. Ambulation as Measured by Distance Walked After Surgery [Post-operative Day 0]

2. Pain as Measure by Numerical Rating Scale (NRS) 11 [24 hours]

   The 11-point numeric rating scale ranges from 0 ("no pain") to 10 ("worst pain imaginable").

3. Cumulative Opioid Consumption [24 hours]

   Total amount of opioids used

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke University Hospital	Durham	North Carolina	United States	27713

Sponsors and Collaborators

• Duke University

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 6, 2021
• Informed Consent Form - Jan 6, 2021

More Information

Publications

None provided.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT03353233
• Other Study ID Numbers: Pro00070573
• First Posted: Nov 27, 2017
• Last Update Posted: Dec 21, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Duke University: iPACK; Interspace between the Popliteal Artery and Capsule of the Knee; Posterior Capsule block; Nerve Block
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Ropivacaine

Study Results

Participant Flow

Arm/Group Title	iPACK Block Group	Sham Group
Arm/Group Description	A nerve block technique using a numbing medication called ropivacaine. Ropivacaine: Local anesthetic (numbing 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.	The same nerve block technique as above, however using an inactive solution of salt water. 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. Saline: An ultrasound guided nerve block using a medication that does NOT numb the nerve called saline, or salt water.
Period Title: Overall Study
STARTED	25	25
COMPLETED	25	25
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	iPACK Block Group	Sham Group	Total
Arm/Group Description	A nerve block technique using a numbing medication called ropivacaine. Ropivacaine: Local anesthetic (numbing 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.	The same nerve block technique as above, however using an inactive solution of salt water. 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. Saline: An ultrasound guided nerve block using a medication that does NOT numb the nerve called saline, or salt water.	Total of all reporting groups
Overall Participants	25	25	50
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	8 32%	11 44%	19 38%
>=65 years	17 68%	14 56%	31 62%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66.84 (6.39)	64.59 (7.01)	65.71 (6.73)
Sex: Female, Male (Count of Participants)
Female	15 60%	13 52%	28 56%
Male	10 40%	12 48%	22 44%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	25 100%	25 100%	50 100%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	5 20%	2 8%	7 14%
White	20 80%	23 92%	43 86%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	25 100%	25 100%	50 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Able to Hyperextend the Knee After Surgery
Description	Ability to hyperextend the knee after surgery
Time Frame	Within 8 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	iPACK Block Group	Sham Group
Arm/Group Description	A nerve block technique using a numbing medication called ropivacaine. Ropivacaine: Local anesthetic (numbing 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.	The same nerve block technique as above, however using an inactive solution of salt water. 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. Saline: An ultrasound guided nerve block using a medication that does NOT numb the nerve called saline, or salt water.
Measure Participants	25	25
Count of Participants [Participants]	4 16%	3 12%

2. Secondary Outcome

Title	Ambulation as Measured by Distance Walked After Surgery
Time Frame	Post-operative Day 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	iPACK Block Group	Sham Group
Arm/Group Description	A nerve block technique using a numbing medication called ropivacaine. Ropivacaine: Local anesthetic (numbing 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.	The same nerve block technique as above, however using an inactive solution of salt water. 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. Saline: An ultrasound guided nerve block using a medication that does NOT numb the nerve called saline, or salt water.
Measure Participants	25	25
Mean (Standard Deviation) [feet]	120.36 (123.1)	148.8 (108.4)

3. Secondary Outcome

Title	Pain as Measure by Numerical Rating Scale (NRS) 11
Description	The 11-point numeric rating scale ranges from 0 ("no pain") to 10 ("worst pain imaginable").
Time Frame	24 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	iPACK Block Group	Sham Group
Arm/Group Description	A nerve block technique using a numbing medication called ropivacaine. Ropivacaine: Local anesthetic (numbing 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.	The same nerve block technique as above, however using an inactive solution of salt water. 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. Saline: An ultrasound guided nerve block using a medication that does NOT numb the nerve called saline, or salt water.
Measure Participants	25	25
Mean (Standard Deviation) [score on a scale]	4.64 (2.74)	5 (2.2)

4. Secondary Outcome

Title	Cumulative Opioid Consumption
Description	Total amount of opioids used
Time Frame	24 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	iPACK Block Group	Sham Group
Arm/Group Description	A nerve block technique using a numbing medication called ropivacaine. Ropivacaine: Local anesthetic (numbing 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.	The same nerve block technique as above, however using an inactive solution of salt water. 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. Saline: An ultrasound guided nerve block using a medication that does NOT numb the nerve called saline, or salt water.
Measure Participants	25	25
Mean (Standard Deviation) [IV morphine equivalents]	47.52 (39.54)	48.98 (36.3)

Adverse Events

Time Frame	From enrollment in study until 24 hours post-op.
Arm/Group Title	iPACK Block Group		Sham Group
Arm/Group Description	A nerve block technique using a numbing medication called ropivacaine. Ropivacaine: Local anesthetic (numbing 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.		The same nerve block technique as above, however using an inactive solution of salt water. 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. Saline: An ultrasound guided nerve block using a medication that does NOT numb the nerve called saline, or salt water.
All Cause Mortality
	iPACK Block Group		Sham Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/25 (0%)
Serious Adverse Events
	iPACK Block Group		Sham Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/25 (0%)
Other (Not Including Serious) Adverse Events
	iPACK Block Group		Sham Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/25 (0%)

Limitations/Caveats

Technical problems with allocations leading to unrelabile and uninterpretable data.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.