Peripheral Nerve Blocks vs Periarticular Local Anesthetic Injection for Total Knee Arthroplasty (TKA)

Phase 4

Completed

Conditions: Total Knee Arthroplasty

Interventions: Drug: Intra articular injection with Ropivacaine
Drug: Intra articular injection with liposomal bupivacaine
Drug: Peripheral nerve blocks with Bupivacaine

Registration Number: NCT02223364

Lead Sponsor: Mayo Clinic

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 165

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) <50 units/m2
- Cardiovascular disorders defined as congestive heart failure (CHF) New York Heart Association (NYHA) class III-IV
- Severe hepatic disorder defined as current or past diagnosis of acute/subacute necrosis liver, acute hepatic failure, chronic liver disease, cirrhosis (primary biliary cirrhosis), fatty liver, chronic hepatitis/toxic hepatitis, liver abscess, hepatic coma, hepatorenal syndrome, other disorders of liver.
Impaired cognitive function or inability to understand the study protocol
Contraindication to a regional anesthesia technique (e.g., preexisting neuropathy in the operative extremity, coagulopathy [platelets < 100,000, International Normalized Ratio (INR) >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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ropivacaine (PAI-R)	Intra articular injection with Ropivacaine	This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
Liposomal Bupivacaine (PAI-L)	Intra articular injection with liposomal bupivacaine	This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
Peripheral Nerve Block (PNB)	Peripheral nerve blocks with Bupivacaine	This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine.

Primary Outcome Measures

Name	Time	Method
Maximum Pain Post-Operative Day (POD) 1 (Morning)	Post-Operative Day 1, approximately 6 am to 12:00 pm	Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.

Secondary Outcome Measures

Name	Time	Method
Maximum Pain Post-PACU	Post-operative Day 0, approximately 12 pm to 12 am	Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.
Maximum Pain POD 1 (24 Hours)	POD 1, approximately 12 am to 12 am next day	Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.
Average Pain POD 2 (24 Hours)	POD 2, approximately 12 am to 12 am next day	Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.
Preoperative Daily Opioid Use	baseline	Opioid consumption will be documented in the patient electronic medical record by the nursing staff caring for the patient.
Intraoperative Opioid Use	During the procedure, approximately 2 hours after start of the procedure	Opioid consumption was documented in the patient electronic medical record by the nursing staff caring for the patient.
Maximum Pain POD 2 (24 Hours)	POD 2, approximately 12 am to 12 am next day	Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.
POD 0 Post-PACU Opioid Use	POD 0, approximately 12 pm to 12 am	Additional opioid medications that were taken by subjects (recorded at the same time as the time points for measuring pain). Opioid consumption was documented in the patient electronic medical record by the nursing staff caring for the patient.
Average Pain Post-Postanesthesia Care Unit (PACU)	Post-operative Day 0, approximately 12 pm to 12 am	Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.
Average Pain POD 1 (24 Hours)	POD 1, approximately 12 am to 12 am next day	Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.
Balance Testing on Operative Leg Using Unipedal Stance Time	baseline, approximately 12 weeks	In order to measure clinical balance, unipedal stance time (UST) was collected as an indicator of balance and fall risk. Timing (in seconds) began upon withdrawal of support and continued until the uplifted foot returned to the floor, the subject required support, or if the subject reached a time limit of 30 seconds. The best performance of three repetitions was recorded for analysis. Normative values for the UST are available. A UST threshold of 30 seconds yields a sensitivity of 95% and a specificity of 58% in identifying those with a history of falls. The first five seconds of unipedal stance is indicative of dynamic balance; inability to maintain unipedal stance for five seconds is a significant predictor of injurious falls.
PACU Opioid Use	Approximately 2 hours after entry in PACU	Opioid consumption was documented in the patient electronic medical record by the nursing staff caring for the patient.
Hospital Length of Stay	Approximately 3 days	The hospital length of stay was measured from the date of admittance until the date of discharge.
POD 1 Opioid Use	POD 1, approximately 12 am to 12 am next day	Additional opioid medications that were taken by subjects (recorded at the same time as the time points for measuring pain). Opioid consumption was documented in the patient electronic medical record by the nursing staff caring for the patient.
POD 2 Opioid Use	POD 2, approximately 12 am to 12 am next day	Additional opioid medications that were taken by subjects (recorded at the same time as the time points for measuring pain). Opioid consumption was documented in the patient electronic medical record by the nursing staff caring for the patient.