Analgesic Efficacy of Different Liposomal Bupivacaine Doses in the Adductor Canal Block for Total Knee Arthroplasty

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorThe University of Hong Kong

About this trial

Total knee arthroplasty is a commonly performed orthopaedic surgery for the treatment of end-stage osteoarthritis when conservative management becomes ineffective. TKA is associated with significant acute postoperative pain and many patients experience severe postoperative pain despite the use of multimodal analgesia. Poor acute postoperative pain control impacts rehabilitation, prolongs recovery and increases opioid consumption and chronic post-surgical pain.

Liposomal bupivacaine (Exparel, Pacira Pharmaceuticals Inc, Parsippany, New Jersey, USA) is a multivesicular formulation of bupivacaine that prolongs drug release and can extend the duration of analgesia. The adductor canal block (ACB) has been shown to reduce pain intensity and opioid consumption after total knee arthroplasty. The use of liposomal bupivacaine in the adductor canal block has recently been FDA-approved. However, the results of its efficacy from existing clinical trials have been mixed. In addition, the doses in the clinical trials have been different, and the optimal dose for perineural application of liposomal bupivacaine is unclear, including for the adductor canal block.

In this project, the investigators propose to conduct a randomized controlled trial to investigate the effect of different doses of liposomal bupivacaine in the adductor canal block on acute postoperative pain intensity and opioid consumption after robotic assisted total knee arthroplasty. The investigators will also assess secondary outcomes including knee functional scores, chronic pain and quality of recovery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

ASA I-III

Age 18-80 years old

Scheduled for elective primary unilateral total knee arthroplasty (TKA) with robotic surgery

Able to speak and understand Cantonese or Mandarin or English

Disqualifiers

Revision TKA

Single-stage bilateral TKA

Complex primary TKA requiring use of stem/augment/constrained liner

Surgeries with significant intraoperative complications which may alter rehabilitation protocol eg collateral ligament injury, fracture requiring fixation

Trial design

Design model

Parallel

Treatments tested in this trial

  • 0.5% standard bupivacaine only

    Drug

    20ml 0.5% standard bupivacaine only

  • 1.33% liposomal bupivacaine with 0.5% standard bupivacaine

    Drug

    10ml 1.33% liposomal bupivacaine (133mg) plus 10ml 0.5% standard bupivacaine

  • 1.33% liposomal bupivacaine only

    Drug

    20ml 1.33% liposomal bupivacaine (266mg)

Treatment groups

177 Participants
are divided into 3 treatment groups
Group A: ACB using 20ml 0.5% standard bupivacaine (SB-ACB)Active comparator 1 intervention
Group B: ACB using 10ml 1.33% liposomal bupivacaine with 10 ml 0.5% standard bupivacaine (LB10-ACB)Experimental treatment 1 intervention
Group C: ACB using 20ml 1.33% liposomal bupivacaine only (LB20-ACB)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Weighted area under curve (AUC) pain score

Pain severity would be rated at rest after surgery using numerical rating scale (NRS) with 0 to 10 where 0=no pain and 10=the worst possible pain

Time frame
The first 48 hours after surgery when the patient is at rest

Secondary outcomes

1

NRS pain scores

NRS pain scores at rest and with movement (active knee flexion) from after surgery to postoperative day (POD) 7, ranging 0-10, with higher scores indicating more severe pain.

Time frame
from after surgery to postoperative day 7
2

Oxynorm consumption

Oxynorm consumption from postoperative day (POD) 1-7

Time frame
Postoperative day 1-7
3

Overall Benefit of Analgesic Score (OBAS)

Overall Benefit of Analgesic Score (OBAS) from postoperative day (POD) 1-7 (range, 0 \[best\] to 28 \[worst\])

Time frame
Postoperative day (POD) 1-7
4

Plasma level of bupivacaine and ropivacaine

Plasma level of bupivacaine and ropivacaine before and after surgery

Time frame
Blood will be collected during induction, at 12 hours, 24 hours, 48 hours, and 72 hours after ACB.

Other outcomes

Sponsors and contacts

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