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

NCT ID: NCT07097493

Last Updated: 2026-01-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-28
• Study Completion Date: 2026-12-31

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.

Detailed Description

This double-blinded prospective randomized control trial will evaluate analgesia following total knee arthroplasty for patients who receive an adductor canal block and infiltration between the popliteal artery and condyles of the knee (iPACK) block utilizing bupivacaine with the adjuvants clonidine, epinephrine, buprenorphine and dexamethasone (BPV-CEBD), as compared to patients who receive liposomal bupivacaine (LB) for both blocks.

All patients will receive a spinal anesthetic with ropivacaine (17.5 mg) and fentanyl (10 mcg), and an adductor canal and iPACK block for analgesia. Patients randomized to the LB group will receive 10 ml of 0.25% bupivacaine expanded with 133 mg (10 ml volume) of LB into both the adductor canal and iPACK blocks (total of 40 ml). The BPV-CEBD group will receive a 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).

On post-operative day (POD) 0, rest and movement pain scores will be collected at 4 hours and 8 hours with time "zero" being the time of the final block placement. On POD 1 and 2, questionnaires will be collected for pain scores at 0700, 1200 and 1700. Participants will be called once daily on days 3 through 7 to collect remaining secondary data, including sleep score, quality of recovery, worst daily pain score, and patient satisfaction (POD 7 only).

Conditions

Knee Arthroplasty, Total

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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)

Liposomal Bupivacaine

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

Group Type: ACTIVE_COMPARATOR

Liposomal Bupivacaine

Intervention Type: 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)

Interventions

Liposomal Bupivacaine

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)

Intervention Type: DRUG

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

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)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 18-80 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Afua Gyamfi, MD

Role: PRINCIPAL_INVESTIGATOR

Atrium Health Wake Forest Baptist

Locations

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, United States

Countries

United States

Central Contacts

Afua Gyamfi, MD

Role: CONTACT

agyamfi@wakehealth.edu

336-716-4498

Lynnette Harris, RN

Role: CONTACT

lynnette.harris@advocatehealth.org

336-716-8791 ext. 336-716-8791

Facility Contacts

Afua Gyamfi, MD

Role: primary

agyuamfi@wakehealth.edu

336-716-4498

James Turner, MD

Role: backup

jturner@wakehealth.edu

336-716-4498

Other Identifiers

IRB00133197

Identifier Type: -

Identifier Source: org_study_id