Phase 4
N=65
Liposomal Bupivacaine for Post Operative Pain After Knee Replacement Surgery
Post-operative Pain
Bottom Line
View on ClinicalTrials.gov: NCT02274870 ↗Enrolled (actual)
65
Serious AEs
0.0%
Results posted
Jun 2018
Primary outcome: Primary: Pain Intensity at Movement — 8.95; 7.91 VAS Scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Liposome Bupivacaine (Drug); Bupivacaine HCl (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northwell Health
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Intensity at Movement |
8.95; 7.91 | — |
| SECONDARY Pain Intensity at Rest |
5.08; 5.16 | — |
| SECONDARY Opioid Consumption |
28.91; 26.32 | — |
| SECONDARY Mean Plasma Bupivicaine Level |
0.04; 1.08 | — |
| SECONDARY Mean Plasma Bupivacaine Levels |
0.29; 1.76 | — |
| SECONDARY Mean Plasma Bupivacaine Level |
0.1; 0.1 | — |
| SECONDARY Mean Plasma Bupivacaine Level |
0.1; 0.1 | — |
| SECONDARY Mean Plasma Bupivacaine Level |
0.1; 0.1 | — |
| SECONDARY Mean Plasma Bupivacaine Level |
0.1; 0.1 | — |
| SECONDARY Mean Plasma Bupivacaine Level |
0.1; 0.1 | — |
Summary
Continuous femoral nerve blocks (CFNB) provide effective pain control to patients undergoing total knee replacement (TKR). However the resulting motor blockade can lead to decreased quadriceps muscle strength and delayed functional recovery.The purpose of this study is to compare the effect of Liposome Bupivacaine infiltration into the knee to CFNB on pain control and functional recovery
Eligibility Criteria
Inclusion Criteria
- ASA Status I-III
- Scheduled to undergo primary unilateral total knee arthroplasty
Exclusion Criteria
- Patients who are pregnant or nursing
- Alcohol or narcotic dependence within the last 2 years
- Condition requiring regular use of analgesia that may confound post surgical assessments as determined by principle investigator
- BMI > 40kg/m2
- Contraindication to acetaminophen, morphine, oxycodone, ketorolac, epinephrine, or pathological conditions potentially aggravated by epinephrine
- Allergies to amide-type local anesthetics
- Any disease condition or lab result that could complicate a patients postoperative recovery
- History of hypotension
- Abnormal liver, renal or cardiac function
- Other physical, mental or medical conditions that, in the opinion of the investigator, make study participation inadvisable.
Data sourced from ClinicalTrials.gov (NCT02274870). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.