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

Total Knee Arthroplasty Clinical Trial

Official title:

Prospective, Randomized, Controlled Trial Comparing Continuous Femoral and Single Injection Sciatic Peripheral Nerve Blocks vs Periarticular Injection With Ropivacaine or Liposomal Bupivacaine (Exparel) on Patients Undergoing Total Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02223364
• Other study ID #: 14-002083
• Status: Completed
• Phase: Phase 4
• First received: July 29, 2014
• Last updated: August 29, 2017
• Start date: July 2014
• Est. completion date: July 2016

Study information

• Verified date: August 2017
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Adult patients with an American Society of Anesthesiologists (ASA) physiological status I-III

2. Patients presenting for unilateral primary total knee replacement.

3. No focal neurologic deficit of the surgical lower extremity.

4. Cognitively intact with the ability to sign informed consent

Exclusion Criteria:

1. Chronic pain syndromes such as fibromyalgia or complex regional pain syndrome

2. History of long term use of daily opioids (>1 months) with oral morphine equivalent (OME) >5mg/day.

3. Body mass index (BMI) > 40 kg/m2

4. Allergies to medications used in this study such as: fentanyl, hydromorphone, ketorolac, ibuprofen, acetaminophen, local anesthetics, oxycodone, OxyContin, tramadol, ondansetron, droperidol, or dexamethasone, celecoxib

5. 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.

6. Impaired cognitive function or inability to understand the study protocol

7. 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.).

8. Previous contralateral knee replacement managed with regional or periarticular injection

9. Unable to follow-up at the 3 month interval at Mayo Clinic in Rochester, Minnesota

10. Pregnancy or breast feeding (women of child-bearing potential, must have a negative pregnancy test)

Related Conditions & MeSH terms

• Total Knee Arthroplasty

Intervention

Drug:
• Peripheral nerve blocks with Bupivacaine
Subjects received Bupivacaine 0.5% preoperatively, then Bupivacaine 0.2% upon post anesthesia care unit (PACU) arrival via femoral nerve block, then Bupivacaine 0.25% via single-injection sciatic nerve.
• Intra articular injection with Ropivacaine
Subjects received an intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Ropivacaine dose depended upon body weight: 50-74.9 kg: 200 mg, 75-99.9 kg: 300 mg, 100-125 kg: 400 mg.
• Intra articular injection with liposomal bupivacaine
Subjects received an intra articular injection with liposomal bupivacaine, a total volume of 120 mL injected in the periarticular structures by the surgeon. Patients weighing 50-125 kg received 266mg of Liposomal Bupivacaine.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

References & Publications (1)

Amundson AW, Johnson RL, Abdel MP, Mantilla CB, Panchamia JK, Taunton MJ, Kralovec ME, Hebl JR, Schroeder DR, Pagnano MW, Kopp SL. A Three-arm Randomized Clinical Trial Comparing Continuous Femoral Plus Single-injection Sciatic Peripheral Nerve Blocks ver — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Pain Post-Operative Day (POD) 1 (Morning)	Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.	Post-Operative Day 1, approximately 6 am to 12:00 pm
Secondary	Average Pain Post-Postanesthesia Care Unit (PACU)	Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.	Post-operative Day 0, approximately 12 pm to 12 am
Secondary	Maximum Pain Post-PACU	Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.	Post-operative Day 0, approximately 12 pm to 12 am
Secondary	Average Pain POD 1 (24 Hours)	Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.	POD 1, approximately 12 am to 12 am next day
Secondary	Maximum Pain POD 1 (24 Hours)	Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.	POD 1, approximately 12 am to 12 am next day
Secondary	Average Pain POD 2 (24 Hours)	Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.	POD 2, approximately 12 am to 12 am next day
Secondary	Maximum Pain POD 2 (24 Hours)	Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.	POD 2, approximately 12 am to 12 am next day
Secondary	Preoperative Daily Opioid Use	Opioid consumption will be documented in the patient electronic medical record by the nursing staff caring for the patient.	baseline
Secondary	Intraoperative Opioid Use	Opioid consumption was documented in the patient electronic medical record by the nursing staff caring for the patient.	During the procedure, approximately 2 hours after start of the procedure
Secondary	PACU Opioid Use	Opioid consumption was documented in the patient electronic medical record by the nursing staff caring for the patient.	Approximately 2 hours after entry in PACU
Secondary	POD 0 Post-PACU Opioid Use	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 0, approximately 12 pm to 12 am
Secondary	POD 1 Opioid Use	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 1, approximately 12 am to 12 am next day
Secondary	POD 2 Opioid Use	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, approximately 12 am to 12 am next day
Secondary	Hospital Length of Stay	The hospital length of stay was measured from the date of admittance until the date of discharge.	Approximately 3 days
Secondary	Balance Testing on Operative Leg Using Unipedal Stance Time	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.	baseline, approximately 12 weeks