Total Hip ArthroplastyPhase 4NCT02242201
Total Hip Arthroplasty (THA) Lumbar Plexus Verses Periarticular
A Phase 4 study testing PNB Bupivacaine, PAI Ropivacaine and PAI liposomal bupivacaine in people with Total Hip Arthroplasty, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Total Hip Arthroplasty
- What is being tested?
- PNB Bupivacaine, PAI Ropivacaine and PAI liposomal bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Sep 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Prospective, Randomized Controlled Trial Comparing Continuous Posterior Lumbar Plexus Nerve Block vs Periarticular Injection With Ropivacaine or Liposomal Bupivacaine (Exparel®) on Patients Undergoing Total Hip Arthroplasty
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®).
Read the detailed description
Total hip arthroplasty is associated with moderate to severe postoperative pain and an ideal clinical pathway for pain management has yet to be established. Multimodal pain management incorporating the use of regional anesthesia for THA has led to decreased hospital length of stay, improved patient comfort, and enhanced patient satisfaction that is efficacious and cost-effective. This investigation compared multimodal total joint arthroplasty pathways with continuous lumbar plexus blockade versus two different periarticular injection mixtures to potentially determine an ideal perioperative analgesia pathway for THA.
Patients undergoing elective, unilateral primary total hip arthroplasty within a clinical pathway utilizing preemptive low-dose opioid and non-opioid medications for multimodal analgesia were randomized to one of three different intervention groups after informed consent was obtained: posterior lumbar plexus block (PNB), periarticular infiltration (PAI) with ropivacaine, ketorolac, and epinephrine, and PAI with liposomal bupivacaine, ketorolac, and epinephrine. The investigators hypothesized differences in the analgesia outcomes between the three intervention groups would provide for an evidenced-based clinical pathway to emerge as a result of this study.
- Conditions
- Total Hip Arthroplasty
- Being tested
- PNB Bupivacaine, PAI Ropivacaine, PAI liposomal bupivacaine, Epinephrine, Ketorolac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PNB BupivacaineDrug
Also called Marcaine
Infusion
PAI RopivacaineDrug
Also called Naropin
Injection
PAI liposomal bupivacaineDrug
Also called Exparel
Injection
EpinephrineDrug
Injection, weight-based dosage of 100 mcg - 300 mcg
KetorolacDrug
Also called Acuvail, Acular
Injection, 30 mg
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: PNB Bupivacaine; Drug: 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. Receives: Drug: PAI Ropivacaine; Drug: Epinephrine; Drug: Ketorolac |
| PAI liposomal bupivacaine | Active comparator | Liposomal bupivacaine 255 mg, ketorolac 30 mg, bupivacaine 125 mg, epinephrine 125 ug. Receives: Drug: PAI liposomal bupivacaine; Drug: Epinephrine; Drug: Ketorolac |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post-Operative Day 1 (0600-1200)
Secondary outcomes (1)
Total Opioid Consumption During Hospitalization
Measured in daily oral morphine equivalents (OME)
Measured: Preoperative, Intraoperative, Postanesthesia Care Unit (PACU), Post Operative Day (POD) 0, day 1, and day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Total Hip ArthroplastyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rebecca L Johnson, MD, Mayo Clinic
- Investigators
- Rebecca Johnson, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02242201
- Sponsor's protocol ID
- 14-004183
- Other IDs
- UL1TR000135
- Status last verified
- Mar 2018
- First submitted
- 13 Sep 2014
- Last updated
- 19 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 29088038
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized Controlled Trial Comparing Continuous Posterior Lumbar Plexus Nerve Block vs Periarticular Injection With Ropivacaine or Liposomal Bupivacaine (Exparel®) on Patients Undergoing Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT02242201
- Acronym / sponsor ID
- 14-004183
- Conditions
- Total Hip Arthroplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 16 Sep 2014 (estimated)
- Results
- Posted 17 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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®).
Detailed description
Total hip arthroplasty is associated with moderate to severe postoperative pain and an ideal clinical pathway for pain management has yet to be established. Multimodal pain management incorporating the use of regional anesthesia for THA has led to decreased hospital length of stay, improved patient comfort, and enhanced patient satisfaction that is efficacious and cost-effective. This investigation compared multimodal total joint arthroplasty pathways with continuous lumbar plexus blockade versus two different periarticular injection mixtures to potentially determine an ideal perioperative analgesia pathway for THA.
Patients undergoing elective, unilateral primary total hip arthroplasty within a clinical pathway utilizing preemptive low-dose opioid and non-opioid medications for multimodal analgesia were randomized to one of three different intervention groups after informed consent was obtained: posterior lumbar plexus block (PNB), periarticular infiltration (PAI) with ropivacaine, ketorolac, and epinephrine, and PAI with liposomal bupivacaine, ketorolac, and epinephrine. The investigators hypothesized differences in the analgesia outcomes between the three intervention groups would provide for an evidenced-based clinical pathway to emerge as a result of this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PNB Bupivacaine | Active comparator | Drug: PNB Bupivacaine, Drug: EpinephrineBupivacaine 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. |
| PAI Ropivacaine | Active comparator | Drug: PAI Ropivacaine, Drug: Epinephrine, Drug: KetorolacPatients 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. |
| PAI liposomal bupivacaine | Active comparator | Drug: PAI liposomal bupivacaine, Drug: Epinephrine, Drug: KetorolacLiposomal bupivacaine 255 mg, ketorolac 30 mg, bupivacaine 125 mg, epinephrine 125 ug. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PNB BupivacaineAlso: MarcaineInfusion | Drug | PNB Bupivacaine |
| PAI RopivacaineAlso: NaropinInjection | Drug | PAI Ropivacaine |
| PAI liposomal bupivacaineAlso: ExparelInjection | Drug | PAI liposomal bupivacaine |
| EpinephrineInjection, weight-based dosage of 100 mcg - 300 mcg | Drug | PAI Ropivacaine, PAI liposomal bupivacaine, PNB Bupivacaine |
| KetorolacAlso: Acuvail, AcularInjection, 30 mg | Drug | PAI Ropivacaine, PAI liposomal bupivacaine |
Primary outcome
Maximum Postoperative Pain Score
Time frame: Post-Operative Day 1 (0600-1200)
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.
1 secondary outcome
Total Opioid Consumption During Hospitalization
Time frame: Preoperative, Intraoperative, Postanesthesia Care Unit (PACU), Post Operative Day (POD) 0, day 1, and day 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 29088038Johnson 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.
- Individual participant dataSharing planned: Undecided
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Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
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PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
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Total Hip Arthroplasty (THA)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Johnson, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PNB Bupivacaine, PAI Ropivacaine and PAI liposomal bupivacaine in people with Total Hip Arthroplasty, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Postoperative Pain Score (time frame: Post-Operative Day 1 (0600-1200)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02242201, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2018.