Does PAI Reduce Pain After TKA Among Knee Arthroplasty Patients Receiving ACB & IPACK?

NCT04749615 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 2019-2096
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to determine whether Periarticular Injection (PAI) alongside Adductor Canal Block (ACB) and Infiltration between the Popliteal Artery and Capsule of the Knee (IPACK) block can decrease post-operative pain in patients undergoing primary total knee arthroplasty. The main question it aims to answer is:

• Is ACB/IPACK without PAI as effective as ACB/IPACK with PAI for TKA patients? Participants will be assigned to one of the following groups at random:
• ACB/PACK with PAI
• ACB/IPACK with saline injection Participants will also be asked to complete pre- and post-operative questionnaires.

Conditions

Total Knee Athroplasty

Keywords

TKA; PAI; ACB; IPACK; Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Pain Scores (NRS, 0-10) With Ambulation on POD1

  The NRS (numeric rating scale) is a questionnaire that measures pain on a numeric scale, 0 (no pain) to 10 (worst pain imaginable). The questionnaire will be asked on post operative discharge day 1.

  24 hours Post Operative Discharge

Secondary Outcomes (17)

• Opioid Use (Cumulative Oral Morphine Equivalents POD0-POD2, 2 Weeks, 3 Months)

  post surgical discharge, 24 hours post surgical discharge, 48 hours post surgical discharge, 2 weeks post surgical discharge, and 3 months post surgical discharge.

• NRS Pain With Movement

  pre-operation, in the post anesthesia care unit (PACU), at post operative (POD) 1, POD 2, and POD 3 months

• Numerical Rating Scale (NRS) Pain Score at Rest

  from pre-operation, post anesthesia care unit (PACU), post operative day (POD) 1, POD 2, and POD 3 months

• PAIN OUT Questionnaire at Preoperation

  at preoperation

• Quality of Recovery (POD1)

  24 hours post surgical discharge.

Study Arms (2)

No PAI + ACB & IPACK

PLACEBO COMPARATOR

Control: saline injection (same injection technique and volumes as described for the active intervention, of normal saline)

Drug: Saline Control Periarticular Injection (PAI)

PAI + ACB & IPACK

ACTIVE COMPARATOR

Active intervention: Periarticular injection: one deep injection prior to cementation and then a second more superficial injection prior to closure. The deep injection will consist of bupivacaine 0.25% with 1:200,000 epinephrine, 30 cc; morphine, 8 mg/ml, 1cc; methylprednisolone, 40 mg/ml, 1 ml; cefazolin, 500 in 10 ml; normal saline, 22cc. The superficial injection will be 20 ml 0.25% bupivacaine

Drug: Periarticular Injection (PAI)

Interventions

Periarticular Injection (PAI) DRUG

PAI is a widely-utilized, surgeon-performed, analgesic intervention for TKA patients.

PAI + ACB & IPACK

Saline Control Periarticular Injection (PAI) DRUG

equal volume of saline will be used in place of analgesics used in PAI injections

No PAI + ACB & IPACK

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Planned use of regional anesthesia
• Ability to follow the major components of the study protocol
• English speaking (Secondary outcomes include questionnaires validated in English only)

You may not qualify if:

• Patients younger than 25 years old and older than 80
• Non-English speaking
• Patients intending to receive general anesthesia
• Contraindication to nerve blocks or peri-articular injection
• Patients with an ASA of IV or higher
• Renal insufficiency (ESRD, HD, estimated creatinine clearance \< 30 ml/min)
• Patients with major prior ipsilateral open knee surgery
• Chronic gabapentin/pregabalin use (regular use for longer than 3 months)
• Chronic opioid use (taking opioids for longer than 3 months)

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Results Point of Contact

• Title: Justas Lauzadis, PhD
• Organization: Hospital for Special Surgery

lauzadisj@hss.edu

212-774-2946

Study Officials

• Jacques YaDeau, MD, PhD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: February 11, 2021
• Study Start: December 17, 2020
• Primary Completion: April 1, 2022
• Study Completion: July 1, 2022
• Last Updated: December 27, 2024
• Results First Posted: June 18, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• Access Criteria: Investigators whose proposed use of the data has been approved by an Independent review committee ("learned intermediary") identified for this purpose and who have signed a DUA.

Locations

US (1)