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Trial of Liposomal Bupivacaine for TKA

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ClinicalTrials.gov Identifier: NCT05635916
Recruitment Status : Completed
First Posted : December 2, 2022
Last Update Posted : July 7, 2023
Sponsor:
Collaborator:
MaineHealth
Information provided by (Responsible Party):
Northern Light Mercy Hospital

Brief Summary:
Total knee arthroplasty (TKA), also known as a knee replacement, is a procedure performed to reduce severe pain and improve function of the joint. Managing postoperative pain can be challenging following TKA, and inadequate relief can lead to impaired mobility and persistent opioid use. Adductor canal nerve blocks (ACB), have shown significant benefit in improving postoperative analgesia and patient satisfaction. However, the local anesthetic used currently for these blocks only provides temporary relief that wears off within 24 hours. Liposomal bupivacaine is an extended-release local anesthetic agent that can provide up to 72 hours of pain relief, however it is unclear if its use is also effective in ACBs for knee surgery. The purpose of this study is to determine if liposomal bupivacaine is better than conventional bupivacaine in improving pain control, opioid consumption, and length of stay in patients scheduled for TKA.

Condition or disease Intervention/treatment Phase
Knee Replacement Total Knee Arthroplasty Post-Operative Pain Drug: Liposomal bupivacaine Drug: Bupivacaine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: The randomization scheme will be developed using NQuery Software (Statistical Solutions, Boston, MA). The analyst will provide the research coordinator with randomization assignments in sequentially-numbered opaque envelopes. As the study is unblinded, both patients and providers will be aware of the randomization assignment. To help mitigate bias, the team members collecting and entering data will be masked regarding the patient's assignment. The REDCap database has the randomization assignments in an instrument separate from the study data collection instruments, allowing for data entry without seeing which group the subject is in.
Primary Purpose: Treatment
Official Title: A Prospective, Randomized Trial of Liposomal Bupivacaine Compared to Conventional Bupivacaine on Pain Control and Post-Operative Opioid Use in Receiving Adductor Canal Blocks for Total Knee Arthroplasty
Actual Study Start Date : September 22, 2022
Actual Primary Completion Date : April 11, 2023
Actual Study Completion Date : April 17, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Experimental: Liposomal Bupivacaine
Adductor canal block using liposomal bupivacaine and conventional bupivacaine
Drug: Liposomal bupivacaine
Adductor canal block with injection of 10cc 13.3% liposomal bupivacaine combined with 10cc 0.50% bupivacaine within one hour following surgery

Active Comparator: Standard of Care
Adductor canal block using conventional bupivacaine
Drug: Bupivacaine
Adductor canal block with injection of 20cc 0.5% bupivacaine within one hour following surgery




Primary Outcome Measures :
  1. To compare the efficacy of liposomal bupivacaine to conventional bupivacaine for adductor canal blocks in adults scheduled for total knee arthroplasty. [ Time Frame: Measured at 24 hours post-op ]
    The primary outcome of this study will be composite pain scores 24 hours after surgery. Others have shown that composite pain scores quantify pain with greater accuracy than a single measurement. Jensen et. al. concluded in their study that composite pain intensity scores from two or more individual ratings of pain are valid for detecting treatment effects.23 Pain scores will be measured using a numeric rating scale (NRS) (0=no pain; 10= worst possible pain) "Worst," "average," and "least" pain scores will be assessed for the preceding time interval at 24, 48, and 72 hours following surgery. If a participant is discharged prior to 72 hours after surgery, they will be given a log to record their pain scores and pain medication use to report to study staff via telephone.

  2. To compare postoperative pain scores and opioid consumption at 48 hours after surgery. [ Time Frame: Measured at 48 hours post-op ]
    The primary outcome of this study will be composite pain scores 24 hours after surgery. Others have shown that composite pain scores quantify pain with greater accuracy than a single measurement. Jensen et. al. concluded in their study that composite pain intensity scores from two or more individual ratings of pain are valid for detecting treatment effects.23 Pain scores will be measured using a numeric rating scale (NRS) (0=no pain; 10= worst possible pain) "Worst," "average," and "least" pain scores will be assessed for the preceding time interval at 24, 48, and 72 hours following surgery. If a participant is discharged prior to 72 hours after surgery, they will be given a log to record their pain scores and pain medication use to report to study staff via telephone.

  3. To compare postoperative pain scores and opioid consumption at 72 hours after surgery. [ Time Frame: Measure at 72 hours post-op ]
    The primary outcome of this study will be composite pain scores 24 hours after surgery. Others have shown that composite pain scores quantify pain with greater accuracy than a single measurement. Jensen et. al. concluded in their study that composite pain intensity scores from two or more individual ratings of pain are valid for detecting treatment effects.23 Pain scores will be measured using a numeric rating scale (NRS) (0=no pain; 10= worst possible pain) "Worst," "average," and "least" pain scores will be assessed for the preceding time interval at 24, 48, and 72 hours following surgery. If a participant is discharged prior to 72 hours after surgery, they will be given a log to record their pain scores and pain medication use to report to study staff via telephone.


Secondary Outcome Measures :
  1. To compare postoperative opioid consumption measured as morphine milligram equivalents (MME) at 24 hours postoperatively. [ Time Frame: Measured intraoperatively, in PACU at 4 hours post-op, and at 24,48, and 72 hours post-op. ]
    For our opioid consumption assessments, data will be collected intraoperatively, in the PACU at 4 hours post-op, and at the 24hr, 48hr, and 72hr timepoints following surgery, as is standard for surgical patients. Information on opioid type and dose will be obtained through review of the participant's electronic medical record or through phone assessment, depending on point of hospital discharge. Opioid amounts will be converted into MMEs.

  2. To compare total length of postoperative stay following surgical stop time. [ Time Frame: Measure at discharge, an average of 1 day. ]
    The time of surgical stop time and discharge will be extracted from the medical record and calculated to length of stay in hours.



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

Inclusion Criteria:

  • Patients 18 years and older who are scheduled for a total knee arthroplasty at Northern Light Mercy Hospital

Exclusion Criteria:

  • Patients under the age of 18

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): NCT05635916


Locations
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United States, Maine
Northern Light Mercy Hospital
Portland, Maine, United States, 04102
Sponsors and Collaborators
Northern Light Mercy Hospital
MaineHealth
Investigators
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Principal Investigator: Brian McAllister, MD Medical Staff & Chief of Anesthesia
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Responsible Party: Northern Light Mercy Hospital
ClinicalTrials.gov Identifier: NCT05635916    
Other Study ID Numbers: 155
First Posted: December 2, 2022    Key Record Dates
Last Update Posted: July 7, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
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