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Effectiveness of Adductor Canal Block Using Liposomal Bupivacaine

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ClinicalTrials.gov Identifier: NCT04003506
Recruitment Status : Not yet recruiting
First Posted : July 1, 2019
Last Update Posted : September 4, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Chan Chi-Wing, The University of Hong Kong

Brief Summary:

Due to population ageing, osteoarthritis of knees and hips become major orthopaedic problems in Hong Kong. Osteoarthritis of knees and hips are associated with significant pain problems and functional disability. Total joint replacement is the ultimate surgical procedure to deal with these problems.

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

The primary aims of total knee replacement are improvement in functional activities and reducing pain due to degenerated knee joints. However, there are around 20-30% of patients who would develop significant pain problems after undergoing 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. Despite the use of multi-modal analgesic technique, pain after total joint replacement remains unsolved. It prolongs the recovery period and increases post-operative analgesic consumption.

Multimodal analgesia which includes 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 for total knee replacement. Compared with femoral nerve block, it involves more sensory blockade. Hence, it has the advantage of quadriceps sparing. Moreover, post-operative mobilization is less affected.

Recent meta-analysis and systemic review suggests that periarticular LIA is associated with better pain control and reduced opioid consumption compared to using ACB alone. However, duration of action and efficacy of a single-dose LIA may not be sufficient for total knee replacement. Whether the combination use of ACB and periarticular LIA has additional benefit of prolonging analgesia or comes with synergistic effect remains controversial. Although recent meta analysis has shown that combined ACB with LIA could significantly reduce pain score and morphine consumption compared with LIA alone after TKA, only 7 RCTS were involved in this analysis. It is essential to have more RCTs to further evaluate the usefulness of combining both LIA and ACB.

Plain bupivacaine or ropivocaine were used in ACB in all previous studies. They are local anaesthetics with half-life ranging from 3-6 hours. With the availability of liposomal bupivacaine, analgesic effect of ACB may be prolonged. It is because the therapeutic level of bupivacaine is below the toxic range and sustained for 72 hours after injection. Only one study evaluated the effect of adductor canal block using liposomal bupivacaine. However, it was a retrospectively study which compared ACB using liposomal bupivacaine and 0.1 % Ropivociane infusion. It didn't evaluate the efficacy of combining ACB using LB and periarticular LIA.

The primary aim of this study is to investigate the efficacy of combining periarticular local infiltration of analgesia and adductor canal block using liposomal bupivacaine


Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: Liposomal bupivacaine Drug: Bupivacaine Injection Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Efficacy of Combining Periarticular Local Infiltration of Analgesia and Adductor Canal Block Using Liposomal Bupivacaine - A Prospective Randomized Controlled Trial
Estimated Study Start Date : October 2020
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group LB
local infiltration of analgesia (LIA) with adductor canal block (ACB) will be given using 10ml of 1.33% liposomal bupivacaine
Drug: Liposomal bupivacaine
LIA with ACB will be given using 10ml of 1.33% liposomal bupivacaine

Active Comparator: group bupivacaine
LIA with ACB will be given using 15ml 0.25% bupivacaine
Drug: Bupivacaine Injection
LIA with ACB will be given using 15ml 0.25% bupivacaine




Primary Outcome Measures :
  1. Pain assessed by numerical rating scales (NRS) pain scores [ Time Frame: at postoperative day 1 ]
    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

  2. PCA morphine consumption [ Time Frame: from postoperative day 0 until postoperative day 5 ]
    Cumulative PCA morphine doses (in mg) will be recorded daily based on medical record.


Secondary Outcome Measures :
  1. Range of motion (ROM) of knee [ Time Frame: from postoperative day 0 until postoperative day 6 ]
    Active and Passive ROM of knee (flexion and extension) will be recorded.

  2. Walking Distance [ Time Frame: from postoperative day 0 until postoperative day 6 ]
    Walking distance will be measured in meters

  3. Degree of assistance [ Time Frame: from postoperative day 0 until postoperative day 6 ]
    Patients' ability to walk will be assessed. There are three categories including walking without help, walking with walking frame and being unable to walk

  4. Ability to stand [ Time Frame: from postoperative day 0 until postoperative day 6 ]
    Patients' ability to stand is recorded after surgery



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ASA I-III
  • Scheduled for elective primary unilateral total knee replacement
  • Chinese patients
  • Able to speak and understand Cantonese
  • Able to provide informed oral and written consent

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04003506


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

Locations
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Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Contact: Chi Wing Chan, MBBS    2255 5791    timmychancw@gmail.com   
Sponsors and Collaborators
The University of Hong Kong
Investigators
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Principal Investigator: Chi Wing Chan, MBBS Queen Mary Hospital, Hong Kong
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Responsible Party: Dr. Chan Chi-Wing, Consultant, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT04003506    
Other Study ID Numbers: UW19-304
First Posted: July 1, 2019    Key Record Dates
Last Update Posted: September 4, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Dr. Chan Chi-Wing, The University of Hong Kong:
bupivacaine
LIA
ACB
total knee replacement
post operative pain
acute pain
anaesthesia
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents