Studies
| Study First Submitted Date | 2019-06-26 |
| Study First Posted Date | 2019-07-01 |
| Last Update Posted Date | 2023-06-26 |
| Start Month Year | August 1, 2023 |
| Primary Completion Month Year | October 2024 |
| Verification Month Year | June 2023 |
| Verification Date | 2023-06-30 |
| Last Update Posted Date | 2023-06-26 |
Facilities
| Sequence: | 199678440 |
| Name | Queen Mary Hospital |
| City | Hong Kong |
| Country | Hong Kong |
Facility Contacts
| Sequence: | 28065407 |
| Facility Id | 199678440 |
| Contact Type | primary |
| Name | Chi Wing Chan, MBBS |
| timmychancw@gmail.com | |
| Phone | 2255 5791 |
Browse Interventions
| Sequence: | 95863614 | Sequence: | 95863615 | Sequence: | 95863616 | Sequence: | 95863617 | Sequence: | 95863618 | Sequence: | 95863619 | Sequence: | 95863620 |
| Mesh Term | Bupivacaine | Mesh Term | Anesthetics, Local | Mesh Term | Anesthetics | Mesh Term | Central Nervous System Depressants | Mesh Term | Physiological Effects of Drugs | Mesh Term | Sensory System Agents | Mesh Term | Peripheral Nervous System Agents |
| Downcase Mesh Term | bupivacaine | Downcase Mesh Term | anesthetics, local | Downcase Mesh Term | anesthetics | Downcase Mesh Term | central nervous system depressants | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | sensory system agents | Downcase Mesh Term | peripheral nervous system agents |
| Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
| Sequence: | 52078471 |
| Name | Pain, Postoperative |
| Downcase Name | pain, postoperative |
Id Information
| Sequence: | 40084868 |
| Id Source | org_study_id |
| Id Value | UW19-304 |
Countries
| Sequence: | 42484343 |
| Name | Hong Kong |
| Removed | False |
Design Groups
| Sequence: | 55491858 | Sequence: | 55491857 |
| Group Type | Active Comparator | Group Type | Experimental |
| Title | group SB | Title | Group LB |
| Description | LIA with ACB will be given using 20ml 0.5%standard bupivacaine | 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 |
Interventions
| Sequence: | 52391559 | Sequence: | 52391560 |
| Intervention Type | Drug | Intervention Type | Drug |
| Name | Liposomal bupivacaine | Name | Bupivacaine Injection |
| Description | LIA with ACB will be given using 10ml of 1.33% liposomal bupivacaine + 10ml 0.5% standard bupivacaine | Description | LIA with ACB will be given using 20ml 0.5% standard bupivacaine |
Keywords
| Sequence: | 79715458 | Sequence: | 79715459 | Sequence: | 79715460 | Sequence: | 79715461 | Sequence: | 79715462 | Sequence: | 79715463 | Sequence: | 79715464 |
| Name | bupivacaine | Name | LIA | Name | ACB | Name | total knee replacement | Name | post operative pain | Name | acute pain | Name | anaesthesia |
| Downcase Name | bupivacaine | Downcase Name | lia | Downcase Name | acb | Downcase Name | total knee replacement | Downcase Name | post operative pain | Downcase Name | acute pain | Downcase Name | anaesthesia |
Design Outcomes
| Sequence: | 177062741 | Sequence: | 177062742 | Sequence: | 177062743 | Sequence: | 177062744 | Sequence: | 177062745 | Sequence: | 177062746 |
| Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
| Measure | Pain assessed by numerical rating scales (NRS) pain scores | Measure | PCA morphine consumption | Measure | Range of motion (ROM) of knee | Measure | Walking Distance | Measure | Degree of assistance | Measure | Ability to stand |
| Time Frame | at postoperative day 1 | Time Frame | from postoperative day 0 until postoperative day 5 | Time Frame | from postoperative day 0 until postoperative day 6 | Time Frame | from postoperative day 0 until postoperative day 6 | Time Frame | from postoperative day 0 until postoperative day 6 | Time Frame | from postoperative day 0 until postoperative day 6 |
| 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 | Description | Cumulative PCA morphine doses (in mg) will be recorded daily based on medical record. | Description | Active and Passive ROM of knee (flexion and extension) will be recorded. | Description | Walking distance will be measured in meters | 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 | Description | Patients' ability to stand is recorded after surgery |
Browse Conditions
| Sequence: | 193117696 | Sequence: | 193117693 | Sequence: | 193117694 | Sequence: | 193117695 | Sequence: | 193117697 |
| Mesh Term | Pain | Mesh Term | Pain, Postoperative | Mesh Term | Postoperative Complications | Mesh Term | Pathologic Processes | Mesh Term | Neurologic Manifestations |
| Downcase Mesh Term | pain | Downcase Mesh Term | pain, postoperative | Downcase Mesh Term | postoperative complications | Downcase Mesh Term | pathologic processes | Downcase Mesh Term | neurologic manifestations |
| Mesh Type | mesh-ancestor | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
| Sequence: | 48233340 |
| Agency Class | OTHER |
| Lead Or Collaborator | lead |
| Name | The University of Hong Kong |
Overall Officials
| Sequence: | 29231231 |
| Role | Principal Investigator |
| Name | Chi Wing Chan, MBBS |
| Affiliation | Queen Mary Hospital, Hong Kong |
Central Contacts
| Sequence: | 11989474 |
| Contact Type | primary |
| Name | Chi Wing Chan, MBBS |
| Phone | 2255 5791 |
| timmychancw@gmail.com | |
| Role | Contact |
Design Group Interventions
| Sequence: | 68026169 | Sequence: | 68026170 |
| Design Group Id | 55491857 | Design Group Id | 55491858 |
| Intervention Id | 52391559 | Intervention Id | 52391560 |
Eligibilities
| Sequence: | 30711442 |
| Gender | All |
| Minimum Age | 18 Years |
| Maximum Age | 80 Years |
| Healthy Volunteers | Accepts Healthy Volunteers |
| Criteria | Inclusion Criteria:
ASA I-III Exclusion Criteria: Revision total knee replacement |
| Adult | True |
| Child | False |
| Older Adult | True |
Calculated Values
| Sequence: | 253938515 |
| Number Of Facilities | 1 |
| Registered In Calendar Year | 2019 |
| Were Results Reported | False |
| Has Us Facility | False |
| Has Single Facility | True |
| Minimum Age Num | 18 |
| Maximum Age Num | 80 |
| Minimum Age Unit | Years |
| Maximum Age Unit | Years |
| Number Of Primary Outcomes To Measure | 2 |
| Number Of Secondary Outcomes To Measure | 4 |
Designs
| Sequence: | 30458027 |
| Allocation | Randomized |
| Intervention Model | Parallel Assignment |
| Observational Model | |
| Primary Purpose | Treatment |
| Time Perspective | |
| Masking | Double |
| Subject Masked | True |
| Investigator Masked | True |
Responsible Parties
| Sequence: | 28824500 |
| Responsible Party Type | Principal Investigator |
| Name | Dr. Chan Chi-Wing |
| Title | Consultant |
| Affiliation | The University of Hong Kong |