IPACK and Adductor Canal Catheter Patient Outcomes for TKAs?

NCT03774966 | Completed Early Phase 1 FDA Drug

• 1 other identifier: 18-001490
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the addition of the IPACK block to the adductor canal block and catheter in the pain management of total knee arthroplasty. Half of participants will receive the adductor canal block and catheter with the IPACK block, while the other half will receive the adductor canal block and catheter only.

Conditions

Surgery; Acute Pain

Keywords

total knee arthroplasty; regional block

Outcome Measures

Primary Outcomes (1)

• Opioid consumption in milligram morphine equivalents

  Total opioid consumption will be calculated for postoperative day 0-3 ( postoperative day 0 is the day of the surgery and is the first day of the time frame and postoperative day 3 is the 4th day) and total hospital stay. Opioid amount will be converted to morphine equivalents (milligram) for comparison.

  4 days

Secondary Outcomes (2)

• Visual analog pain scores

  4 days

• Distance ambulated during physical therapy

  4 days

Study Arms (2)

Adductor Canal Block + Catheter

ACTIVE COMPARATOR

Adductor canal block: 15 mL of 0.25% ropivicaine, adductor canal catheter: 6 mL/hr of 0.2% ropivacaine

Procedure: Adductor canal block + catheter

Adductor Canal Block + Catheter & IPACK

EXPERIMENTAL

Adductor canal block: 15 mL of 0.25% ropivicaine, adductor canal catheter: 6 mL/hr of 0.2% ropivacaine, IPACK block: 15 ml of 0.25% ropivacaine.

Procedure: Adductor Canal Block + Catheter & IPACK block

Interventions

Adductor Canal Block + Catheter & IPACK block PROCEDURE

Adductor Canal Block + Catheter \& IPACK block

Adductor Canal Block + Catheter & IPACK

Adductor canal block + catheter PROCEDURE

Adductor canal block + catheter

Adductor Canal Block + Catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing total knee replacement without contraindications to regional blocks

You may not qualify if:

• Patients who have contraindications to regional blocks: infection at injection site for the nerve block, allergy to local anesthetics, history of a bleeding disorder

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA Medical Center, Santa Monica

Santa Monica, California, 90404, United States

Location

Related Publications (2)

• Cullom C, Weed JT. Anesthetic and Analgesic Management for Outpatient Knee Arthroplasty. Curr Pain Headache Rep. 2017 May;21(5):23. doi: 10.1007/s11916-017-0623-y.

  PMID: 28283810 BACKGROUND

• Thobhani S, Scalercio L, Elliott CE, Nossaman BD, Thomas LC, Yuratich D, Bland K, Osteen K, Patterson ME. Novel Regional Techniques for Total Knee Arthroplasty Promote Reduced Hospital Length of Stay: An Analysis of 106 Patients. Ochsner J. 2017 Fall;17(3):233-238.

  PMID: 29026354 RESULT

MeSH Terms

Conditions

Acute Pain

Interventions

Catheters

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 4, 2018
• First Posted: December 13, 2018
• Study Start: February 12, 2019
• Primary Completion: May 28, 2019
• Study Completion: May 28, 2019
• Last Updated: February 19, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)