NCT04539730
Withdrawn
Phase 4
Does the Addition of Liposomal Bupivacaine to the Adductor Canal Block Impact Narcotic Use After Primary Total Knee Arthroplasty: a Prospective, Blind Randomized Control Trial
InterventionsLiposomal bupivacaine
Overview
- Phase
- Phase 4
- Intervention
- Liposomal bupivacaine
- Conditions
- Arthroplasty Complications
- Sponsor
- University of Miami
- Primary Endpoint
- Opioid Use
- Status
- Withdrawn
- Last Updated
- 4 years ago
Overview
Brief Summary
The purpose of this study is to evaluate whether liposomal bupivacaine is superior to normal bupivacaine in terms of providing better pain control postoperatively after total knee arthroplasty.
Investigators
Jaime Carvajal Alba
Assistant Professor
University of Miami
Eligibility Criteria
Inclusion Criteria
- •The subject is scheduled for elective unilateral primary TKA
- •The subject is ≥ 18 years
- •The subject's primary anesthesia care team has planned for a neuraxial anesthetic (i.e. spinal, epidural or combined-spinal epidural)
- •The patient consents for an adductor canal block
- •Willing and able to sign an informed consent.
Exclusion Criteria
- •Patients unwilling or unable to consent to participate in the study.
- •Reported to have mental illness or belonging to a vulnerable population.
- •Subject is \< 18 years of age.
- •Patients receiving general anesthesia for the total knee arthroplasty.
- •Subject has impaired decision-making capacity per discretion of the Investigator.
- •Any condition for which the primary anesthesia care team deems neuraxial anesthesia inappropriate.
- •Significant pre-existing neuropathy on the operative limb.
- •Significant chronic pain disorders (i.e. fibromyalgia, complex regional pain syndrome I \& II, among others).
- •Subject has sustained a significant trauma to the operative knee.
- •Chronic Opioid Use (daily or almost daily use of opioids for \> 3 months).
Arms & Interventions
Liposomal Bupivacaine Intervention Group
Participants undergoing elective TKA surgery that are randomized to the intervention group will undergo an ultrasound-guided ACB with Liposomal Bupivacaine post TKA surgery.
Intervention: Liposomal bupivacaine
Outcomes
Primary Outcomes
Opioid Use
Time Frame: Up to 2 weeks
Opioid use after SoC TKA surgery will be evaluated as morphine milligram equivalents
Secondary Outcomes
- Post-Operative Pain Score(Up to 5 days)
- Patient Satisfaction as per the Knee Society Score(Up to Week 6)
- Number of participants requiring narcotic prescriptions(2 weeks)
- Distance Ambulated with physical therapist(Up to 5 days)
- Length of hospitalization(Up to 5 days)
- Incidence of events of PONV(Up to 5 days)
- Incidence of urinary retention from narcotic use(2 Weeks)
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