NCT02242201

Brief Summary

Total hip arthroplasty is a one of the most commonly performed surgical procedures with increasing numbers anticipated over the next several decades. The purpose of this study was to find a better way to make patients comfortable after their hip surgery. Three different ways of providing pain relief were compared, a peripheral nerve block in the lower back outside of the spinal space (using bupivacaine, a numbing medicine), or injections around the hip joint with one of two different medicines, either Ropivacaine or Liposomal Bupivacaine (Exparel®).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

January 17, 2018

Completed
Last Updated

April 19, 2018

Status Verified

March 1, 2018

Enrollment Period

2 years

First QC Date

September 13, 2014

Results QC Date

December 13, 2017

Last Update Submit

March 21, 2018

Conditions

Total Hip Arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Maximum Postoperative Pain Score

    Pain was measured on an ascending numeric rating scale (NRS) from 0-10 where 1-3 equaled mild pain, 4-6 equaled moderate pain, 7-9 equaled severe pain, and 10 equaled worst possible pain.

    Post-Operative Day 1 (0600-1200)

Secondary Outcomes (1)

  • Total Opioid Consumption During Hospitalization

    Preoperative, Intraoperative, Postanesthesia Care Unit (PACU), Post Operative Day (POD) 0, day 1, and day 2

Other Outcomes (7)

  • Hospital Length of Stay

    Post-operative Day 1 through discharge (approximately 3 days)

  • Change in Unipedal Stance Time

    Baseline, 3 months

  • Post-Operative Pain Score

    3 month follow-up

  • +4 more other outcomes

Study Arms (3)

PNB Bupivacaine

ACTIVE COMPARATOR

Bupivacaine 0.5% with 1:200,000 epinephrine 30 ml bolus preoperatively followed by an infusion of bupivacaine 0.2% on post anesthesia care unit (PACU) arrival.

Drug: PNB BupivacaineDrug: Epinephrine

PAI Ropivacaine

ACTIVE COMPARATOR

Patients 50 to 74.9 kg: ropivacaine 200 mg, epinephrine 100 ug, ketorolac 30 mg. Patients 75 to 99.9 kg: ropivacaine 300 mg, epinephrine 200 ug, ketorolac 30 mg. Patients 100 to 125 kg: ropivacaine 400 mg, epinephrine 300 ug, ketorolac 30mg.

Drug: PAI RopivacaineDrug: EpinephrineDrug: Ketorolac

PAI liposomal bupivacaine

ACTIVE COMPARATOR

Liposomal bupivacaine 255 mg, ketorolac 30 mg, bupivacaine 125 mg, epinephrine 125 ug.

Drug: PAI liposomal bupivacaineDrug: EpinephrineDrug: Ketorolac

Interventions

PNB BupivacaineDRUG

Infusion

Also known as: Marcaine
PNB Bupivacaine
PAI RopivacaineDRUG

Injection

Also known as: Naropin
PAI Ropivacaine
PAI liposomal bupivacaineDRUG

Injection

Also known as: Exparel
PAI liposomal bupivacaine
EpinephrineDRUG

Injection, weight-based dosage of 100 mcg - 300 mcg

PAI RopivacainePAI liposomal bupivacainePNB Bupivacaine
KetorolacDRUG

Injection, 30 mg

Also known as: Acuvail, Acular
PAI RopivacainePAI liposomal bupivacaine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (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 hip arthroplasty
  • Patients 18 years of age and older

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, tramadol, ondansetron, droperidol, dexamethasone, celecoxib and OxyContin
  • 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 of 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 hip replacement managed with regional or periarticular injection
  • Unable to follow-up at the 3 month interval at Mayo Clinic in Rochester, Minnesota
  • Pregnancy or breastfeeding (women of child-bearing potential will require a negative pregnancy test)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • Johnson RL, Amundson AW, Abdel MP, Sviggum HP, Mabry TM, Mantilla CB, Schroeder DR, Pagnano MW, Kopp SL. Continuous Posterior Lumbar Plexus Nerve Block Versus Periarticular Injection with Ropivacaine or Liposomal Bupivacaine for Total Hip Arthroplasty: A Three-Arm Randomized Clinical Trial. J Bone Joint Surg Am. 2017 Nov 1;99(21):1836-1845. doi: 10.2106/JBJS.16.01305.

    PMID: 29088038RESULT

MeSH Terms

Interventions

BupivacaineRopivacaineEpinephrineKetorolacKetorolac Tromethamine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesEthanolaminesAmino AlcoholsAlcoholsBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsIndomethacinIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Limitations and Caveats

PNB and PAI for total hip arthroplasty are highly technique dependent modalities and standardized delivery of PAI injections is less established than PNB.

Results Point of Contact

Title
Dr. Rebecca L. Johnson
Organization
Mayo Clinic
Johnson.Rebecca1@mayo.edu
507-266-2049

Study Officials

  • Rebecca Johnson, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

September 13, 2014

First Posted

September 16, 2014

Study Start

September 1, 2014

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

April 19, 2018

Results First Posted

January 17, 2018

Record last verified: 2018-03

Locations

US(1)