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Effectiveness of Adductor Canal Block Using Liposomal Bupivacaine

Primary Purpose

Pain, Postoperative

Status
Not yet recruiting
Phase
Phase 4
Locations
Hong Kong
Study Type
Interventional
Intervention
Liposomal bupivacaine
Bupivacaine Injection
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring bupivacaine, LIA, ACB, total knee replacement, post operative pain, acute pain, anaesthesia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Queen Mary Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group LB

group SB

Arm Description

local 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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Range of motion (ROM) of knee
Active and Passive ROM of knee (flexion and extension) will be recorded.
Walking Distance
Walking distance will be measured in meters
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
Ability to preform straight leg raising
Patients' ability to preform straight leg raising is recorded after surgery
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.

Full Information

First Posted
June 26, 2019
Last Updated
October 2, 2023
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT04003506
Brief Title
Effectiveness of Adductor Canal Block Using Liposomal Bupivacaine
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong

4. Oversight

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

5. Study Description

Brief 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. However total joints 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
bupivacaine, LIA, ACB, total knee replacement, post operative pain, acute pain, anaesthesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group LB
Arm Type
Experimental
Arm Description
local 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
Arm Title
group SB
Arm Type
Active Comparator
Arm Description
LIA with ACB will be given using 20ml 0.5%standard bupivacaine
Intervention Type
Drug
Intervention Name(s)
Liposomal bupivacaine
Intervention Description
LIA with ACB will be given using 10ml of 1.33% liposomal bupivacaine + 10ml 0.5% standard bupivacaine
Intervention Type
Drug
Intervention Name(s)
Bupivacaine Injection
Intervention Description
LIA with ACB will be given using 20ml 0.5% standard bupivacaine
Primary Outcome Measure Information:
Title
Pain assessed by numerical rating scales (NRS) pain scores
Description
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
Time Frame
at postoperative day 1
Secondary Outcome Measure Information:
Title
Range of motion (ROM) of knee
Description
Active and Passive ROM of knee (flexion and extension) will be recorded.
Time Frame
from postoperative day 0 until postoperative day 6
Title
Walking Distance
Description
Walking distance will be measured in meters
Time Frame
from postoperative day 0 until postoperative day 6
Title
Degree of assistance
Description
Patients' ability to walk will be assessed. There are three categories including walking without help, walking with walking frame and being unable to walk
Time Frame
from postoperative day 0 until postoperative day 6
Title
Ability to preform straight leg raising
Description
Patients' ability to preform straight leg raising is recorded after surgery
Time Frame
from postoperative day 0 until postoperative day 6
Title
Plasma level of bupivacaine and ropivacaine.
Description
Blood sample would be collected and plasma level of bupivacaine and ropivacaine would be measured using liquid chromatography coupled mass spectrometry.
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chi Wing Chan, MBBS
Phone
2255 5791
Email
timmychancw@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chi Wing Chan, MBBS
Organizational Affiliation
Queen Mary Hospital, Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chi Wing Chan, MBBS
Phone
2255 5791
Email
timmychancw@gmail.com

12. IPD Sharing Statement

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Effectiveness of Adductor Canal Block Using Liposomal Bupivacaine

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