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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
177
20ml 0.5% standard bupivacaine only
10ml 1.33% liposomal bupivacaine (133mg) plus 10ml 0.5% standard bupivacaine
20ml 1.33% liposomal bupivacaine (266mg)
The University of Hong Kong
Hong Kong, Hong Kong, Hong Kong
RECRUITINGWeighted 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
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
Oxynorm consumption
Oxynorm consumption from postoperative day (POD) 1-7
Time frame: Postoperative day 1-7
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
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.
Quality of Recovery Questionnaire (QoR-9)
Quality of Recovery Questionnaire (QoR-9) on postoperative day 1, ranging from 0 to 18, with higher scores indicating good recovery after anaesthesia.
Time frame: Postoperative day 1
Rehabilitation parameters (range of maximal active knee flexion)
Range of maximal active knee flexion will be assessed by the physiotherapists while the patient is in hospital.
Time frame: While the patient is in hospital from postoperative day 0, day 1, and day 2.
Rehabilitation parameters (quadricep power)
Quadricep power will be assessed by the physiotherapists while the patient is in hospital. Ratings: 0 - no muscle contraction 1. \- Move w/o gravity 2. \- Raise then drop down immediately 3. \- Raise against gravity w/o resistance 4. \- Raise against gravity w/some resistance 5. \- Raise against gravity w/ full resistance
Time frame: While the patient is in hospital from postoperative day 0, day 1, and day 2.
Rehabilitation parameters (ability to perform straight leg raising)
Ability to perform straight leg raising will be assessed by the physiotherapists while the patient is in hospital. Ratings (Yes/ No).
Time frame: While the patient is in hospital from postoperative day 0, day 1, and day 2.
Rehabilitation parameters (walking distance)
Walking distance (in metres) will be assessed by the physiotherapists while the patient is in hospital.
Time frame: While the patient is in hospital from postoperative day 0, day 1, and day 2.
Rehabilitation parameters (Duration of hospital stay)
No. of hospitalization days from admission to discharge
Time frame: estimated on average of postoperative day 7 at the date of discharge from hospital
Rehabilitation parameters (discharge location)
Home or rehabilitation center
Time frame: estimated on average of postoperative day 7 at the date of discharge from hospital
Opioid-related side effects
Presence or absence of pruritus, dizziness, nausea, and vomiting will be recorded.
Time frame: While the patient is in hospital from postoperative day 0, 1, and 2.
Potential side effects related to adductor canal block (ACB)
Presence or absence of local anaesthetic toxicity, neurological injury, and intravascular injection will be recorded.
Time frame: While the patient is in hospital from postoperative day 0, 1, and 2.
Analgesic block duration
Measured in time to return of pain (When did your pain relief from the block completely wear off?), time to sensory resolution (When did your numbness completely resolve and return to normal?), and time to motor resolution (When did your arm or hand weakness resolve and return to normal?)
Time frame: While the patient is in hospital at postoperative day 1
Sensory and motor assessment
The affected lower limb will be measured. Sensory assessment (Sensation to pin prick), rating from 0 (no sensation) to 10 (normal sensation) Motor assessment * Straight leg raising achieved Ratings (Yes/ No) * Quadriceps power Ratings: 0 - no muscle contraction 1. \- Move w/o gravity 2. \- Raise then drop down immediately 3. \- Raise against gravity w/o resistance 4. \- Raise against gravity w/some resistance 5. \- Raise against gravity w/ full resistance
Time frame: While the patient is in hospital from post-block 2 hours, 6 hours, 12 hours, and 24 hours.
quality of life (SF12v2)
Eight domains of SF-12v2 (HK) are measured on a scale ranging from 0 to 100. A higher domain score indicates a better HRQoL.
Time frame: at 6 weeks and at 3 and 6 months after surgery
Identification Pain Questionnaire for Neuropathic Pain (ID-NeP)
Neuropathic pain will be assessed using Identification Pain Questionnaire for Neuropathic Pain (ID-NeP), consisting of six items: "Yes" answers to questions 1-5 were given a score of 1, while "yes" answer to question 6 scored -1. "No" answers to questions 1-5 were given a score of 0, while "yes" answer to question 6 scored 0.
Time frame: at 6 weeks, 3 months and 6 months postoperatively
Knee Society Knee Function Score
Knee Society Knee Function Score at 6 weeks, 3 months and 6 months postoperatively, from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions.
Time frame: at 6 weeks, 3 months and 6 months postoperatively
Chronic post-surgical pain
The presence or absence of chronic post-surgical pain, pain scores if present.
Time frame: at 6 weeks, 3 months and 6 months postoperatively
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