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NCT Number: NCT07097493

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

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)

Primary outcomes

  1. Pain Score with Movement

    Time frame: Baseline

    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

  2. Pain Score with Movement

    Time frame: Hour 4 post final block placement

    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

  3. Pain Score with Movement

    Time frame: Hour 8 post final block placement

    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

Secondary outcomes

  1. Pain Score with Rest

    Time frame: Hour 48 post final block placement

    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

  2. Pain Score with Rest

    Time frame: Hour 72 post final block placement

    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

  3. Pain Score with Movement

    Time frame: Hour 72 post final block placement

    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

  4. Highest Daily Pain Score

    Time frame: Postop Days 3, 4, 5, 6, 7

    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

  5. Cumulative Opioid Consumption

    Time frame: Hour 48 post final block placement

    all opioids consumed and recorded in morphine milligram equivalents (MME) for postoperative Day 2

  6. Cumulative Opioid Consumption

    Time frame: Hour 72 post final block placement

    all opioids consumed and recorded in morphine milligram equivalents (MME) for postoperative Day 3

  7. Quality of Recovery-15 Patient Survey

    Time frame: Postop Days 3, 4, 5, 6, 7

    quality of life questions rated on a 0-10 scale for 0=none of the time up to 10=all of the time on a daily basis; pain/nausea/vomiting/depression questions answered in a 10=none of the time down to a 0=all of the time (scales reversed on that scale)

  8. Distance Walked

    Time frame: 24 hours

    distance (feet) walked during first physical therapy appointment

  9. PROMIS Sleep Disturbance Survey

    Time frame: Postop Days 3, 4, 5, 6, 7

    quality of sleep rated on a scale of 0=very poor/not at all up to 5=very good/very much

  10. Patient Satisfaction

    Time frame: Postop Day 7

    measured with a 5-point Likert scale 0=not satisfied at all up to 5=best level of satisfaction

  11. Incidence of Postoperative Nausea

    Time frame: Up to Postop Day 7

    overall number of nausea occurrences

  12. Incidence of Postoperative Vomiting

    Time frame: Up to Postop Day 7

    overall number of vomiting occurrences

Study contacts

Contact information is provided by the study sponsor or research team.

Afua Gyamfi, MD

CONTACT

[email protected]

336-716-4498

Lynnette Harris, RN

CONTACT

[email protected]

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

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

Liposomal Bupivacaine vs Perineural Adjuvants in Adductor Canal and iPACK Blocks in Patients Undergoing Primary Total Knee Arthroplasty

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 31, 2025
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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