Phase 4
N=165
Peripheral Nerve Blocks vs Periarticular Local Anesthetic Injection for Total Knee Arthroplasty (TKA)
Total Knee Arthroplasty
Bottom Line
View on ClinicalTrials.gov: NCT02223364 ↗Enrolled (actual)
165
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcome: Primary: Maximum Pain Post-Operative Day (POD) 1 (Morning) — 3; 4; 4.5 units on a scale — p=0.144
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Peripheral nerve blocks with Bupivacaine (Drug); Intra articular injection with Ropivacaine (Drug); Intra articular injection with liposomal bupivacaine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Pain Post-Operative Day (POD) 1 (Morning) |
3; 4; 4.5 | 0.144 |
| SECONDARY Average Pain Post-Postanesthesia Care Unit (PACU) |
0.6; 1.7; 2.4 | 0.003 sig |
| SECONDARY Maximum Pain Post-PACU |
1; 4; 5 | <0.001 sig |
| SECONDARY Average Pain POD 1 (24 Hours) |
2.5; 3.5; 3.7 | 0.059 |
| SECONDARY Maximum Pain POD 1 (24 Hours) |
5.5; 6; 6 | 0.189 |
| SECONDARY Average Pain POD 2 (24 Hours) |
3.3; 3.2; 3.5 | 0.958 |
| SECONDARY Maximum Pain POD 2 (24 Hours) |
5; 6; 6 | 0.493 |
| SECONDARY Preoperative Daily Opioid Use |
15; 15; 15 | 0.571 |
| SECONDARY Intraoperative Opioid Use |
10; 10; 10 | 0.807 |
| SECONDARY PACU Opioid Use |
0; 0; 0 | — |
| SECONDARY POD 0 Post-PACU Opioid Use |
0; 8; 15 | 0.012 sig |
| SECONDARY POD 1 Opioid Use |
26; 38; 45 | 0.202 |
| SECONDARY POD 2 Opioid Use |
23; 15; 23 | 0.933 |
| SECONDARY Hospital Length of Stay |
2; 2; 2 | 0.768 |
| SECONDARY Balance Testing on Operative Leg Using Unipedal Stance Time |
24; 16; 17; 20; 30; 23 | 0.623 |
Summary
The purpose of this study is to find a better way to make patients comfortable after their knee surgery. The investigators compared three ways of providing pain relief, either by use of a nerve block at the femoral and sciatic nerve areas, or with actual injections in the surgical joint area with one of two different medicines, either ropivacaine or liposomal bupivacaine (Exparel®). The hypothesis was that the nerve block at the femoral and sciatic nerve areas would result in lower pain scores and opioid consumption than either of the two injections in the surgical joint area.
Eligibility Criteria
Inclusion Criteria
- Adult patients with an American Society of Anesthesiologists (ASA) physiological status I-III
- Patients presenting for unilateral primary total knee replacement.
- No focal neurologic deficit of the surgical lower extremity.
- Cognitively intact with the ability to sign informed consent
Exclusion Criteria
- Chronic pain syndromes such as fibromyalgia or complex regional pain syndrome
- History of long term use of daily opioids (>1 months) with oral morphine equivalent (OME) >5mg/day.
- Body mass index (BMI) > 40 kg/m2
- Allergies to medications used in this study such as: fentanyl, hydromorphone, ketorolac, ibuprofen, acetaminophen, local anesthetics, oxycodone, OxyContin, tramadol, ondansetron, droperidol, or dexamethasone, celecoxib
- Major systemic medical problems such as:
- Severe renal disorder defined as glomerular filtration rate (GFR) 1.5], refusal, etc.).
- Previous contralateral knee replacement managed with regional or periarticular injection
- Unable to follow-up at the 3 month interval at Mayo Clinic in Rochester, Minnesota
- Pregnancy or breast feeding (women of child-bearing potential, must have a negative pregnancy test)
Data sourced from ClinicalTrials.gov (NCT02223364). 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.