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
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Condition or disease | Intervention/treatment | Phase |
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Knee Replacement Total Knee Arthroplasty Post-Operative Pain | Drug: Liposomal bupivacaine Drug: Bupivacaine | Phase 4 |
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 |
Arm | Intervention/treatment |
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Experimental: Liposomal Bupivacaine
Adductor canal block using liposomal bupivacaine and conventional bupivacaine
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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
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Drug: Bupivacaine
Adductor canal block with injection of 20cc 0.5% bupivacaine within one hour following surgery |
- 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.
- 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.
- 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.
- 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.
- 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 |
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
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
United States, Maine | |
Northern Light Mercy Hospital | |
Portland, Maine, United States, 04102 |
Principal Investigator: | Brian McAllister, MD | Medical Staff & Chief of Anesthesia |
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 |
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 |
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 |