Phase 3 Adductor Canal Block With EXPAREL in Subjects Undergoing Primary Unilateral Total Knee Arthroplasty

Knee Osteoarthritis Clinical Trial

Official title:

A Phase 3, Randomized, Double-Blind, Multicenter, Active-Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of EXPAREL Admixed With Bupivacaine HCl vs. Bupivacaine HCl Administered Via Adductor Canal Block for Postsurgical Analgesia in Subjects Undergoing Primary Unilateral Total Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05139030
• Other study ID #: 402-C-335
• Status: Completed
• Phase: Phase 3
• Start date: January 18, 2022
• Est. completion date: July 11, 2022

Study information

• Verified date: July 2022
• Source: Pacira Pharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to compare magnitude of postsurgical analgesic effect in different groups following a single dose of study drug when administered via adductor canal block in subjects undergoing primary unilateral total knee arthroplasty.

Description:

This is a Phase 3, multicenter, randomized, double-blind, active-controlled study in approximately 160 subjects undergoing primary unilateral TKA under spinal anesthesia. The study will have 2 cohorts, enrolling in parallel.

Cohort 1 -PK, PD, Efficacy, and Safety, Cohort 2 -Efficacy and Safety

An adaptive study design will be used in this study. An interim analysis to evaluate the sample size assumptions and evaluate futility will occur when a total of approximately 80 subjects (40 subjects in each arm) combined from either Cohort 1 or Cohort 2 have enrolled and provided complete assessment data for the primary efficacy outcome.

The time from study drug administration until the end of participation is POD 14 (±3 days). Therefore, subjects may participate in the study for up to 62 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 167
• Est. completion date: July 11, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male or female, ages 18 or older at screening.

2. Indicated to undergo primary unilateral total knee arthroplasty under spinal anesthesia.

3. Primary indication for TKA is degenerative osteoarthritis of the knee.

4. American Society of Anesthesiologists (ASA) physical status 1, 2, or 3.

5. Able to provide informed consent, adhere to the study schedule, and complete all study assessments.

6. Body Mass Index (BMI) =18 and <40 kg/m2.

Exclusion Criteria:

1. Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications for which an alternative is not named in the protocol (e.g., amide-type local anesthetics, opioids, bupivacaine HCl, NSAIDs).

2. Planned concurrent surgical procedure (e.g., bilateral TKA).

3. Undergoing unicompartmental TKA or revision TKA.

4. Concurrent painful physical condition (e.g., arthritis, fibromyalgia, cancer) that may require analgesic treatment with NSAIDs or opioids in the post dosing period for pain that is not strictly related to the knee surgery and which, in the Investigator's opinion, may confound the post dosing assessments.

5. Inadequate sensory function below the knee as assessed by the Investigator.

6. History of contralateral TKA within 1 year.

7. Previous open knee surgery on the knee being considered for TKA. Prior arthroscopy is permitted.

8. History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.

9. Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study.

10. Previous participation in an EXPAREL study.

11. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the Investigator, could interfere with study assessments or compliance.

12. Currently pregnant, nursing, or planning to become pregnant during the study.

13. Clinically significant medical disease that, in the opinion of the Investigator, would make participation in a clinical study inappropriate. This includes diabetic neuropathy, coagulation or bleeding disorders, severe peripheral vascular disease, renal insufficiency, hepatic dysfunction, or other conditions that would constitute a contraindication to participation in the study.

14. Currently on a neuromodulating agent (e.g., gabapentin, pregabalin [Lyrica], duloxetine [Cymbalta], etc.)].

15. Current use of systemic glucocorticoids within 30 days of randomization in this study.

16. Use of dexmedetomidine HCl (Precedex®) or clonidine within 3 days of study drug administration.

17. Any use of marijuana [including Tetrahydrocannabinol (THC) and Cannabidiol (CBD)] within 30 days prior to randomization, or planned use during the course of the study.

18. Chronic opioid use (average =30 oral morphine equivalents/day) within 30 days prior to randomization.

Given the COVID-19 pandemic, if there is a concern about a subject's recent or potential exposure to COVID-19, or if the subject is not medically fit/cleared for surgery due to suspected COVID-19 illness/symptoms, the subject must be excluded per Exclusion criterion #13.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee
• Pain Management

Intervention

Drug:
• bupivacaine liposome injectable suspension
Adductor canal block with EXPAREL
• Bupivacaine Hydrochloride
Adductor Canal Block with bupivacaine HCl

Locations

Country	Name	City	State
United States	First Surgical Hospital	Bellaire	Texas
United States	HD Research- Legent Orthopedic Hospital	Carrollton	Texas
United States	Midwest Clinical Research Center, LLC	Dayton	Ohio
United States	Woodland International Research Group	Little Rock	Arkansas
United States	Lotus Clinical Research	Pasadena	California
United States	Endeavor Clinical Trials	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Pacira Pharmaceuticals, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NRS scores through 96 hours post-surgery	The area under the curve (AUC) of the NRS pain intensity scores from 0 to 96 hours post-surgery.	0 to 96 hours post-surgery
Secondary	Postsurgical Opioid Consumption through 96 hours post-surgery	Total postsurgical opioid consumption in oral morphine equivalents (OMED) from 0 to 96 hours post-surgery.	0 to 96 hours post-surgery
Secondary	Time to first opioid	Time to first opioid consumption post-surgery	0 to 96 hours post-surgery
Secondary	NRS scores	Worst and average NRS pain intensity scores at 24h, 48h, 72h and 96h from the end of surgery	0-24hours, 0-48hours, 0-72hours, 0-96hours