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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorWake Forest University Health Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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)

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Liposomal BupivacaineActive comparator 1 intervention
Group B: Bupivacaine, Clonidine, Epinephrine, Buprenorphine and Dexamethasone (BPV-CEBD)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Baseline
2

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

Time frame
Hour 4 post final block placement
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

Time frame
Hour 8 post final block placement

Secondary outcomes

1

Pain Score with Rest

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

Time frame
Hour 48 post final block placement
2

Pain Score with Rest

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

Time frame
Hour 72 post final block placement
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

Time frame
Hour 72 post final block placement
4

Highest Daily Pain Score

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

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

Other outcomes

Sponsors and contacts

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