Trial of Liposomal Bupivacaine for TKA

NCT05635916 | Completed Phase 4 FDA Drug

• 1 other identifier: 155
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Total knee arthroplasty (TKA), also known as a knee replacement, is a procedure performed to reduce severe pain and improve function of the joint. Managing postoperative pain can be challenging following TKA, and inadequate relief can lead to impaired mobility and persistent opioid use. Adductor canal nerve blocks (ACB), have shown significant benefit in improving postoperative analgesia and patient satisfaction. However, the local anesthetic used currently for these blocks only provides temporary relief that wears off within 24 hours. Liposomal bupivacaine is an extended-release local anesthetic agent that can provide up to 72 hours of pain relief, however it is unclear if its use is also effective in ACBs for knee surgery. The purpose of this study is to determine if liposomal bupivacaine is better than conventional bupivacaine in improving pain control, opioid consumption, and length of stay in patients scheduled for TKA.

Conditions

Knee Replacement; Total Knee Arthroplasty; Post-Operative Pain

Outcome Measures

Primary Outcomes (3)

• To compare the efficacy of liposomal bupivacaine to conventional bupivacaine for adductor canal blocks in adults scheduled for total knee arthroplasty.

  The primary outcome of this study will be composite pain scores 24 hours after surgery. Others have shown that composite pain scores quantify pain with greater accuracy than a single measurement. Jensen et. al. concluded in their study that composite pain intensity scores from two or more individual ratings of pain are valid for detecting treatment effects.23 Pain scores will be measured using a numeric rating scale (NRS) (0=no pain; 10= worst possible pain) "Worst," "average," and "least" pain scores will be assessed for the preceding time interval at 24, 48, and 72 hours following surgery. If a participant is discharged prior to 72 hours after surgery, they will be given a log to record their pain scores and pain medication use to report to study staff via telephone.

  Measured at 24 hours post-op

• To compare postoperative pain scores and opioid consumption at 48 hours after surgery.

  The primary outcome of this study will be composite pain scores 24 hours after surgery. Others have shown that composite pain scores quantify pain with greater accuracy than a single measurement. Jensen et. al. concluded in their study that composite pain intensity scores from two or more individual ratings of pain are valid for detecting treatment effects.23 Pain scores will be measured using a numeric rating scale (NRS) (0=no pain; 10= worst possible pain) "Worst," "average," and "least" pain scores will be assessed for the preceding time interval at 24, 48, and 72 hours following surgery. If a participant is discharged prior to 72 hours after surgery, they will be given a log to record their pain scores and pain medication use to report to study staff via telephone.

  Measured at 48 hours post-op

• To compare postoperative pain scores and opioid consumption at 72 hours after surgery.

  The primary outcome of this study will be composite pain scores 24 hours after surgery. Others have shown that composite pain scores quantify pain with greater accuracy than a single measurement. Jensen et. al. concluded in their study that composite pain intensity scores from two or more individual ratings of pain are valid for detecting treatment effects.23 Pain scores will be measured using a numeric rating scale (NRS) (0=no pain; 10= worst possible pain) "Worst," "average," and "least" pain scores will be assessed for the preceding time interval at 24, 48, and 72 hours following surgery. If a participant is discharged prior to 72 hours after surgery, they will be given a log to record their pain scores and pain medication use to report to study staff via telephone.

  Measure at 72 hours post-op

Secondary Outcomes (2)

• To compare postoperative opioid consumption measured as morphine milligram equivalents (MME) at 24 hours postoperatively.

  Measured intraoperatively, in PACU at 4 hours post-op, and at 24,48, and 72 hours post-op.

• To compare total length of postoperative stay following surgical stop time.

  Measure at discharge, an average of 1 day.

Study Arms (2)

Liposomal Bupivacaine

EXPERIMENTAL

Adductor canal block using liposomal bupivacaine and conventional bupivacaine

Drug: Liposomal bupivacaine

Standard of Care

ACTIVE COMPARATOR

Adductor canal block using conventional bupivacaine

Drug: Bupivacaine

Interventions

Liposomal bupivacaine DRUG

Adductor canal block with injection of 10cc 13.3% liposomal bupivacaine combined with 10cc 0.50% bupivacaine within one hour following surgery

Liposomal Bupivacaine

Bupivacaine DRUG

Adductor canal block with injection of 20cc 0.5% bupivacaine within one hour following surgery

Standard of Care

Eligibility Criteria

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

You may qualify if:

• Patients 18 years and older who are scheduled for a total knee arthroplasty at Northern Light Mercy Hospital

You may not qualify if:

• Patients under the age of 18

Sponsors & Collaborators

• Northern Light Mercy Hospital: lead
• MaineHealth: collaborator

Study Sites (1)

Northern Light Mercy Hospital

Portland, Maine, 04102, United States

Location

Related Publications (1)

• Quaye A, McAllister B, Garcia JR, Nohr O, Laduzenski SJ, Mack L, Kerr CR, Kerr DA, Razafindralay CN, Richard JM, Craig WY, Rodrigue S. A prospective, randomized trial of liposomal bupivacaine compared to conventional bupivacaine on pain control and postoperative opioid use in adults receiving adductor canal blocks for total knee arthroplasty. Arthroplasty. 2024 Feb 1;6(1):6. doi: 10.1186/s42836-023-00226-y.

  PMID: 38297390 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Brian McAllister, MD

  Medical Staff & Chief of Anesthesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The randomization scheme will be developed using NQuery Software (Statistical Solutions, Boston, MA). The analyst will provide the research coordinator with randomization assignments in sequentially-numbered opaque envelopes. As the study is unblinded, both patients and providers will be aware of the randomization assignment. To help mitigate bias, the team members collecting and entering data will be masked regarding the patient's assignment. The REDCap database has the randomization assignments in an instrument separate from the study data collection instruments, allowing for data entry without seeing which group the subject is in.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: December 2, 2022
• Study Start: September 22, 2022
• Primary Completion: April 11, 2023
• Study Completion: April 17, 2023
• Last Updated: July 7, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)