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

Mayo Clinic

Status and phase: Completed; Phase 4

Conditions: Total Knee Arthroplasty

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02223364

14-002083

Details and patient eligibility

About

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.

Enrollment: 165 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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165 participants in 3 patient groups

Peripheral Nerve Block (PNB)

Active Comparator group

Description:

This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine.

Treatment:

Drug: Peripheral nerve blocks with Bupivacaine

Ropivacaine (PAI-R)

Active Comparator group

Description:

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.

Treatment:

Drug: Intra articular injection with Ropivacaine

Liposomal Bupivacaine (PAI-L)

Active Comparator group

Description:

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.

Treatment:

Drug: Intra articular injection with liposomal bupivacaine