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Pain, PostoperativePhase 4NCT04003506

Effectiveness of Adductor Canal Block Using Liposomal Bupivacaine

A Phase 4 study testing Liposomal bupivacaine and Bupivacaine Injection in people with Pain, Postoperative, run by The University of Hong Kong at 1 site in Hong Kong.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

With aging of population, osteoarthritis of knees and hips become major orthopaedic problems in Hong Kong. Osteoarthritis of knees and hips are associated with significant pain problem and functional disability. Total joints replacement is the ultimate surgical procedures to deal with such problems. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Pain, Postoperative
What is being tested?
Liposomal bupivacaine and Bupivacaine Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteHong Kong
Study dates
1 Mar 2024to Oct 2026
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ASA I-III
  • Age 18-80 years old
  • Scheduled for elective primary unilateral total knee replacement
  • Chinese patients
  • BMI < 40
  • Able to speak and understand Cantonese
  • Able to provide informed oral and written consent

Who cannot join

  • Revision total knee replacement
  • Single stage bilateral total knee replacement
  • Known allergy to opioids, local anaesthetic drugs, paracetamol, non-steroidal anti-inflammatory drugs (NSAIDS) including COX-2 inhibitors
  • History of chronic pain other than chronic knee pain
  • History of immunosuppression
  • Daily use of glucocorticoids
Show all 18Show fewer
  • Daily use of strong opioids (morphine, fentanyl, hydromorphone, ketobemidone, methadone, nicomorphine, oxycodone, or meperidine)
  • History of severe heart disease (NYHA 2)
  • Alcohol or drug abuse
  • Impaired renal function, defined as preoperative serum creatinine level over 120 μmol/L
  • Pre-existing neurological or muscular disorders
  • Psychiatric illness or neurologic or psychiatric diseases potentially influencing pain perception
  • Impaired or retarded mental state
  • Difficulties in using patient controlled analgesia (PCA)
  • Pregnancy
  • Local infection
  • On immunosuppresants
  • Patient refusal

Trial locations and contacts

1 site in 1 country.

Chi Wing Chan, MBBS contact

2255 5791

timmychancw@gmail.com

Hong Kong1 site
  • Queen Mary Hospital

    Hong Kong

    Chi Wing Chan, MBBS, 2255 5791, timmychancw@gmail.com

Other trials in Hong Kong

About this study

Official title: Comparing the Efficacy of Combining Periarticular Local Infiltration of Analgesia and Adductor Canal Block Using Liposomal Bupivacaine and Standard Bupivacaine in Total Knee Arthroplasty - A Prospective Randomized Controlled Trial

With aging of population, osteoarthritis of knees and hips become major orthopaedic problems in Hong Kong. Osteoarthritis of knees and hips are associated with significant pain problem and functional disability. Total joints replacement is the ultimate surgical procedures to deal with such problems.

However total joints replacement is associated with significant tissue damage and post-operative pain problems, which would affect post-operative recovery and rehabilitation.

Read more

The primary aims of total knee replacement are improvement in functional activities and reduce pain due to degenerated knee joints. However, there are around 20-30% of patients would develop significant pain problem despite uncomplicated total knee replacement. It accounts for major post-operative problems and burdens.

Procedure specific analgesic method with multi-model analgesia technique is well-known to be useful in post-operative pain management, which reduces the post-operative pain score. However, despite using of multi-modal analgesic technique, pain after total joint replacement is still the most unsolved issue. It prolongs the recovery period and increases post-operative analgesic consumptions.

Multimodal analgesia, including periarticular local infiltration of analgesia (LIA), regional nerve block, opioid and non-opioid have been shown to be effective in managing postoperative pain.

Periarticular LIA has been shown to be an effective way of pain management. Regional nerve block using femoral nerve block or adductor canal block (ACB) is also a well-established anlagesic technique after total knee replacement. Comparing with femoral nerve block, it involves more sensory blockade so has the advantage of quadriceps sparing, less affecting the post-operative mobilization.

From most recent systematic reviews and randomized controlled trials, it becomes clear that periarticular LIA has better pain control with less opioid consumption than ACB alone. However, duration of a single-dose LIA may not be long enough after total knee replacement. Recent meta-analysis has shown that combined ACB with LIA could significantly reduce pain scores and morphine consumption compared LIA alone after TKA. Standard bupivacaine, levobupivocaine, ropivocaine were used in ACB in these studies. They are local anaesthetic with half-life ranging from 3-6 hours.

With the availability of liposomal bupivacaine (LB), ACB using LB may further prolong the analgesic effect of ACB as the therapeutic levels of bupivacaine, which are below the toxic range and sustained for 72 hours after injection. Therefore, the issue is whether ACB using LB has even longer analgesic effect than plain bupivacaine or ropivacaine. There was only one study directly compared ACB using LB and 0.1% ropivociane infusion. It was shown that LB had significant impact in pain control in the first 36 hours. However, this was a retrospective study and there was difference in delivery of local anaesthetics (single shot injection for liposomal bupivacaine but continuous infusion for ropivacaine).

The primary aim of this study is to investigate whether ACB using liposomal bupivacaine has even longer analgesic effect than standard bupivacaine (SB) and its cost effectiveness. Secondary aims are to evaluate the pharmacokinetic data of standard bupivacaine and liposomal bupivacaine in adductor canal block and pharmacokinetic data of ropivocaine level in LIA.

Being tested
Liposomal bupivacaine, Bupivacaine Injection
Keywords
bupivacaine, LIA, ACB, total knee replacement, post operative pain, acute pain, anaesthesia
Medical subject headings
Pain, Postoperative, Acute Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Liposomal bupivacaineDrug

    LIA with ACB will be given using 10ml of 1.33% liposomal bupivacaine + 10ml 0.5% standard bupivacaine

  • Bupivacaine InjectionDrug

    LIA with ACB will be given using 20ml 0.5% standard bupivacaine

Study groups in NCT04003506
Study groupRoleWhat they receive
Group LBExperimentallocal infiltration of analgesia (LIA) with adductor canal block (ACB) will be given using 10ml of 1.33% liposomal bupivacaine with 10ml 0.5% standard bupivacaine
Receives: Drug: Liposomal bupivacaine
group SBActive comparatorLIA with ACB will be given using 20ml 0.5%standard bupivacaine
Receives: Drug: Bupivacaine Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain assessed by numerical rating scales (NRS) pain scores

    NRS pain scores (from 0-10, where 0 is the least satisfaction and 10 most satisfaction) will be recorded during movement and at rest, by NRS (movement) and NRS (rest) respectively

    Measured: at postoperative day 1

Secondary outcomes (5)
  1. Range of motion (ROM) of knee

    Active and Passive ROM of knee (flexion and extension) will be recorded.

    Measured: from postoperative day 0 until postoperative day 6

  2. Walking Distance

    Walking distance will be measured in meters

    Measured: from postoperative day 0 until postoperative day 6

  3. Degree of assistance

    Patients' ability to walk will be assessed. There are three categories including walking without help, walking with walking frame and being unable to walk

    Measured: from postoperative day 0 until postoperative day 6

  4. Ability to preform straight leg raising

    Patients' ability to preform straight leg raising is recorded after surgery

    Measured: from postoperative day 0 until postoperative day 6

  5. Plasma level of bupivacaine and ropivacaine.

    Blood sample would be collected and plasma level of bupivacaine and ropivacaine would be measured using liquid chromatography coupled mass spectrometry.

    Measured: at before ACB, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 20 hours, 24 hours, 48 hours, and 72 hours after ACB.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2019
  2. Study start1 Mar 2024 (estimated)
  3. Primary completionOct 2026 (estimated)
  4. Study completionOct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04003506
Sponsor's protocol ID
UW19-304
Status last verified
Nov 2023
First submitted
26 Jun 2019
Last updated
1 Dec 2023
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Liposomal bupivacaine and Bupivacaine Injection in people with Pain, Postoperative, run by The University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Chi Wing Chan, MBBS (2255 5791, timmychancw@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain assessed by numerical rating scales (NRS) pain scores (time frame: at postoperative day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2023.

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