Liposomal Bupivacaine vs Perineural Adjuvants in Adductor Canalf and iPACK Blocks in Total Knee Arthroplasty

NCT07097493 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: IRB00133197
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to compare two different combinations of anesthetic medications to see which works the best in providing the longest lasting pain relief for total knee arthroplasty surgery. The drugs being used are liposomal bupivacaine compared to a combination of bupivacaine, clonidine, epinephrine, buprenorphine, and dexamethasone. Pain scores will be collected at different intervals during study participation.

Conditions

Knee Arthroplasty, Total

Keywords

pain; knee surgery; pain management

Outcome Measures

Primary Outcomes (3)

• Pain Score with Movement

  numerical rating scale pain score with movement utilizing the numerical rating pain score scale of 0 to 10, where 0 is no pain and 10 is the worst imaginable pain

  Baseline

• Pain Score with Movement

  numerical rating scale pain score with movement utilizing the numerical rating pain score scale of 0 to 10, where 0 is no pain and 10 is the worst imaginable pain

  Hour 4 post final block placement

• Pain Score with Movement

  numerical rating scale pain score with movement utilizing the numerical rating pain score scale of 0 to 10, where 0 is no pain and 10 is the worst imaginable pain

  Hour 8 post final block placement

Secondary Outcomes (12)

• Pain Score with Rest

  Hour 48 post final block placement

• Pain Score with Rest

  Hour 72 post final block placement

• Pain Score with Movement

  Hour 72 post final block placement

• Highest Daily Pain Score

  Postop Days 3, 4, 5, 6, 7

• Cumulative Opioid Consumption

  Hour 48 post final block placement

Study Arms (2)

Liposomal Bupivacaine

ACTIVE COMPARATOR

randomized to liposomal bupivacaine in the adductor canal and infiltration between the popliteal artery and condyles of the knee (iPACK) block

Drug: Liposomal Bupivacaine

Bupivacaine, Clonidine, Epinephrine, Buprenorphine and Dexamethasone (BPV-CEBD)

ACTIVE COMPARATOR

randomized to bupivacaine mixed with clonidine, epinephrine, buprenorphine and dexamethasone in the adductor canal and infiltration between the popliteal artery and condyles of the knee (iPACK) block

Drug: Bupivacaine, Clonidine, Epinephrine, Buprenorphine and Dexamethasone (BPV-CEBD) Combination

Interventions

Liposomal Bupivacaine DRUG

10 ml of 0.25% bupivacaine expanded with 133 mg (10 ml volume) of liposomal bupivacaine into both the adductor canal and iPACK blocks (total of 40 ml)

Liposomal Bupivacaine

Bupivacaine, Clonidine, Epinephrine, Buprenorphine and Dexamethasone (BPV-CEBD) Combination DRUG

20 ml of solution consisting of 0.25% bupivacaine, 1.667mcg/ml of clonidine, 1:400,000 epinephrine, 0.15 mg total of buprenorphine, and 2 mg total of preservative free dexamethasone which will be used in both the adductor canal block and iPACK block (total of 40 ml)

Bupivacaine, Clonidine, Epinephrine, Buprenorphine and Dexamethasone (BPV-CEBD)

Eligibility Criteria

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

You may qualify if:

• years of age
• Receiving primary total knee arthroplasty
• Patients receiving a spinal anesthetic with ropivacaine and fentanyl
• American Society of Anesthesiology (ASA) category 1 to 3

You may not qualify if:

• Revision of Total Knee Arthroplasty
• Opioid use in the prior 6 months \> 40 mg oxycodone equivalents per day or long-acting opioids as determined by the Prescription Drug Monitoring Program (PDMP)
• Patients planned to receive general anesthesia
• Patients planned to receive a spinal other than ropivacaine
• History of peripheral neuropathy
• Poorly controlled diabetes (Hgb A1C \>8)
• Allergies or contraindications to study medications: acetaminophen, celecoxib (including sulfa), methocarbamol, midazolam, fentanyl, bupivacaine, dexamethasone, acetaminophen, buprenorphine, NSAIDs, clonidine, epinephrine, and liposomal bupivacaine.
• Unable to provide informed consent

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Pain; Agnosia

Interventions

Bupivacaine; Clonidine; Epinephrine; Buprenorphine; Dexamethasone

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated

Study Officials

• Afua Gyamfi, MD

  Atrium Health Wake Forest Baptist

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Afua Gyamfi, MD

CONTACT

336-716-4498; agyamfi@wakehealth.edu

Lynnette Harris, RN

CONTACT

336-716-8791; lynnette.harris@advocatehealth.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: July 31, 2025
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 23, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)