Total Knee Arthroplasty Infiltration Study for Postoperative Analgesia

Postoperative Pain Clinical Trial

Official title:

A Phase 2b, Randomized, Double-Blind, Saline Placebo- and Active-Controlled, Multicenter Study of HTX-011 Via Infiltration for Postoperative Analgesia in Subjects Undergoing Total Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03015532
• Other study ID #: HTX-011-209
• Status: Completed
• Phase: Phase 2
• Start date: January 13, 2017
• Est. completion date: May 16, 2018

Study information

• Verified date: September 2021
• Source: Heron Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase 2b, randomized, double-blind, saline placebo- and active-controlled, multicenter study in subjects undergoing primary unilateral total knee arthroplasty (TKA) to evaluate the analgesic efficacy, safety, and pharmacokinetics (PK) of HTX-011 administered via infiltration to the surgical site.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 285
• Est. completion date: May 16, 2018
• Est. primary completion date: April 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Is scheduled to undergo primary unilateral TKA under general anesthesia.

• Has not previously undergone TKA in either knee.

• Has an American Society of Anesthesiologists Physical Status of I, II, or III.

• Is able to demonstrate motor function by performing a timed 20-meter walk unassisted, but with the optional use of a 4-legged walker for balance.

• Female subjects are eligible only if not pregnant, not lactating, not planning to become pregnant during the study, sterile; or using acceptable contraceptives.

Exclusion Criteria:

• Has a planned concurrent surgical procedure (eg, bilateral TKA).

• Has a pre-existing concurrent acute or chronic painful/restrictive physical condition that may require analgesic treatment in the postoperative period for pain.

• Has a contraindication or a known or suspected history of hypersensitivity or idiosyncratic reaction to required study medications.

• Has known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months.

• Has taken NSAIDs within 10 days prior to the scheduled surgery.

• Has taken opioids within 24 hours prior to the scheduled surgery (3 days for long-acting).

• Has been administered bupivacaine within 5 days prior to the scheduled surgery.

• Has initiated treatment with medications within 1 month prior to study drug administration that can impact pain control.

• Has been administered systemic steroids within 5 half-lives or 10 days prior to administration of study drug.

• Has a medical condition such that, in the opinion of the Investigator, participating in the study would pose a health risk to the subject or confound the postoperative assessments.

• Has a known history of Hepatitis B, human immunodeficiency virus (HIV), or active Hepatitis C.

• Has uncontrolled anxiety, psychiatric, or neurological disorder that might interfere with study assessments.

• Has any chronic neuromuscular deficit of either femoral nerve function or thigh musculature. Has any chronic condition or disease that would compromise neurological or vascular assessments.

• Had a malignancy in the last year, with the exception of non-metastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix.

• Has a known or suspected history of drug abuse, a positive drug screen on the day of surgery, or a recent history of alcohol abuse.

• Received an investigational product or device in a clinical trial within 30 days or within 5 elimination half lives.

• Has undergone 3 or more surgeries within 12 months.

• Has a body mass index (BMI) >38 kg/m2.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• HTX-011
HTX-011 (bupivacaine/meloxicam), via instillation
• Saline Placebo
Saline placebo via injection
• Bupivicaine HCl
Bupivacaine HCl without epinephrine
• Ropivacaine
Ropivacaine, via injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Heron Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Area Under the Curve (AUC) of the NRS-R (Windowed Worst Observation Carried Forward) Pain Intensity Scores	Pain intensity scores are assessed using an 11-point Numeric Rating Scale (NRS) (0-10) where 0 represents "no pain" and 10 represents "worst pain imaginable". NRS scores are recorded at rest (NRS-R).	48 hours
Secondary	Mean Area Under the Curve (AUC) of the NRS-R (Windowed Worst Observation Carried Forward) Pain Intensity Scores	Pain intensity scores are assessed using an 11-point Numeric Rating Scale (NRS) (0-10) where 0 represents "no pain" and 10 represents "worst pain imaginable". NRS scores are recorded at rest (NRS-R).	72 hours
Secondary	Mean Total Postoperative Opioid Consumption (in Morphine Equivalents)		72 hours