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

NCT02223364 | Completed Phase 4 Results

• 1 other identifier: 14-002083
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Average Pain Post-Postanesthesia Care Unit (PACU)

  Post-operative Day 0, approximately 12 pm to 12 am

• Maximum Pain Post-PACU

  Post-operative Day 0, approximately 12 pm to 12 am

• Average Pain POD 1 (24 Hours)

  POD 1, approximately 12 am to 12 am next day

• Maximum Pain POD 1 (24 Hours)

  POD 1, approximately 12 am to 12 am next day

• Average Pain POD 2 (24 Hours)

  POD 2, approximately 12 am to 12 am next day

Study Arms (3)

Peripheral Nerve Block (PNB)

ACTIVE COMPARATOR

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

Drug: Peripheral nerve blocks with Bupivacaine

Ropivacaine (PAI-R)

ACTIVE COMPARATOR

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.

Drug: Intra articular injection with Ropivacaine

Liposomal Bupivacaine (PAI-L)

ACTIVE COMPARATOR

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.

Drug: Intra articular injection with liposomal bupivacaine

Interventions

Peripheral nerve blocks with Bupivacaine DRUG

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.

Also known as: Marcaine, Sensorcaine

Peripheral Nerve Block (PNB)

Intra articular injection with Ropivacaine DRUG

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.

Also known as: Naropin

Ropivacaine (PAI-R)

Intra articular injection with liposomal bupivacaine DRUG

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.

Also known as: Exparel

Liposomal Bupivacaine (PAI-L)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related 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 versus Periarticular Injection with Ropivacaine or Liposomal Bupivacaine for Patients Undergoing Total Knee Arthroplasty. Anesthesiology. 2017 Jun;126(6):1139-1150. doi: 10.1097/ALN.0000000000001586.

  PMID: 28234636 RESULT

MeSH Terms

Interventions

Bupivacaine; Injections, Intra-Articular; Ropivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Dr. Sandra L. Kopp
• Organization: Mayo Clinic

Kopp.Sandra@mayo.edu

507-284-6637

Study Officials

• Sandra Kopp, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology

Study Record Dates

• First Submitted: July 29, 2014
• First Posted: August 22, 2014
• Study Start: July 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: August 31, 2017
• Results First Posted: August 31, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)