Total Hip ArthroplastyNCT01556724
A Comparison of Postoperative Analgesic Nerve Block Ropivacaine Concentrations
A study testing 0.1% or 0.2% ropivacaine nerve blocks in people with Total Hip Arthroplasty and Postoperative Pain, run by Sylvia Wilson at 1 site in United States.
Trial summary
Peripheral nerve blocks are the standard of care for pain management after hip replacement surgery at UPMC Shadyside. This prospective, randomized study is intended to assess the effect of 0.1 versus 0.2% ropivacaine in lumbar plexus nerve catheter infusions after total hip arthroplasty. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Total Hip Arthroplasty, Postoperative Pain
- What is being tested?
- 0.1% or 0.2% ropivacaine nerve blocks
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Dec 2014
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years old
- American Society of Anesthesiologists physical status score I-III
- Scheduled for primary total hip arthroplasty at UPMC Shadyside Hospital in Pittsburgh, PA.
- No contraindications to peripheral nerve catheter placement
- Patients not expected to receive therapeutic anticoagulation in the postoperative period.
- No known drug allergies to study medications
- Patients willing to receive spinal anesthesia as operative anesthetic
Who cannot join
- Age under 18 years or older than 75 years.
- Any contraindication to a placement of continuous lumbar plexus peripheral nerve catheter.
- American Society of Anesthesiologist physical status IV or greater.
- Chronic painful conditions.
- Preoperative opioid tolerant use (opioid use for greater than 6 contiguous months before surgery).
- Coagulation abnormalities or patients who are expected to be on therapeutic anticoagulants postoperatively.
Show all 13Show fewer
- Allergy to any of the drugs/agents used study protocol.
- Pregnancy
- Having an altered mental status (not oriented to place, person, or time)
- Any comorbid condition that, in the judgment of the consulting orthopedic surgeon or intraoperative anesthesiologist, would proscribe the patient from any aspect of the study.
- Patient refusal.
- Patient requiring postoperative management in the ICU
- Lumbar plexus catheter placed by loss of resistance technique.
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Presbyterian Shadyside
Pittsburgh, Pennsylvania, 15232
About this study
Official title: A Comparison of 0.1 and 0.2% Ropivacaine in Lumbar Plexus Catheters After Primary Total Hip Arthroplasty: a Comparison of Postoperative Analgesia and Motor Function.
Peripheral nerve blocks are the standard of care for pain management after hip replacement surgery at UPMC Shadyside. This prospective, randomized study is intended to assess the effect of 0.1 versus 0.2% ropivacaine in lumbar plexus nerve catheter infusions after total hip arthroplasty. Ropivacaine peripheral nerve block infusions have been utilized as the standard of care at UPMC Shadyside for many years. Ropivacaine, a less potent left-isomer of bupivacaine, is often used in place of bupivacaine due to less motor blockade and less severe cardiovascular and central nervous system potential toxicity.
The primary goal of this study to examine the effect of a low concentration infusion of ropivacaine (0.1%) on postoperative analgesia (evaluated by opioid consumption after 36 hours) compared with the standard accepted concentration of 0.2% ropivacaine in lumbar plexus catheters after primary total hip arthroplasty. Secondary goals are to examine motor function, VAS scores and patient satisfaction with pain control in low concentration 0.1% ropivacaine compared with 0.2% ropivacaine lumbar plexus infusions upto 36 hours after primary total hip arthroplasty.
Read the detailed description
Lumbar plexus catheters are the standard of care for postoperative pain management following total hip arthroplasty (THA) at UPMC Shadyside. The safety and efficacy of this technique has been demonstrated by multiple studies. Ropivacaine 0.2% was used for many years at UPMC Shadyside and throughout the UPMC system and this concentration of ropivacaine is the standard local anesthetic utilized by multiple other studies. However, this concentration of ropivacaine was later decreased to 0.1% in our institution in order to decrease patient's motor weakness and promote postoperative physical therapy. Patients were clinically observed to continue to have adequate postoperative analgesia while demonstrating improved motor function. A randomized, double blinded clinical trial has never compared 0.1 and 0.2% ropivacaine.
- Conditions
- Total Hip Arthroplasty, Postoperative Pain
- Being tested
- 0.1% or 0.2% ropivacaine nerve blocks
- Keywords
- Peripheral nerve blocks, Ropivacaine concentrations in lumbar plexus catheters, Postoperative pain, Total hip replacement
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.1% or 0.2% ropivacaine nerve blocksDrug
Also called Naropin (ropivacaine hcl)
Either 0.1% or 0.2% ropivacaine will be infused at 7 mL/hr through lumbar plexus nerve block catheter based upon randomization, and can then receive a 6 ml bolus of either 0.1% or 0.2% ropivacaine. Additional pain relief will be available by nurse administered boluses of additional local anesthetic (from their randomized infusion) with a maximum dose of an extra 3 ml per bolus and limited to one bolus per hour. This bolus of their randomized local anesthetic will remain available until the nerve catheters are removed. Nerve block infusion rates may be increased to 9 ml/h for patients with increased pain without increased motor blockade as determined by the acute interventional perioperative pain service (AIPPS) or decreased to 5 ml/h for patients with increased motor blockade or weakness from the peripheral nerve block as determined by the AIPPS .All continuous lumbar plexus catheters will be removed on post operative day (POD) 2.
| Study group | Role | What they receive |
|---|---|---|
| 0.2% ropivacaine nerve block (standard of care) | Active comparator | 0.2% ropivacaine in lumbar plexus nerve catheter infusions for postoperative analgesia Receives: Drug: 0.1% or 0.2% ropivacaine nerve blocks |
| 0.1% ropivacaine infusion in nerve block catheter | Experimental | 0.1% ropivacaine in lumbar plexus nerve catheter infusions Receives: Drug: 0.1% or 0.2% ropivacaine nerve blocks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opiate Consumption Postoperatively
Postoperative opiate consumption at 24 hours
Measured: 24 hours postoperatively
Secondary outcomes (4)
Patient Satisfaction With Pain Control
Patient satisfaction with pain control at 24 hours (0-10 scale). Patients' satisfaction was assessed using an 11-point numeric scale (0-10, 0 = unsatisfied and 10 = very satisfied). Scores at 24 hours were not averaged with any other scores.
Measured: 24 hours postoperatively
Numeric Rating Scale Pain Score With Movement at 24 Hours
Numeric rating scale (NRS) pain score with movement were assessed at 24 hours. Pain scores were followed using an 11-point NRS (0 = no pain and 10 = worst imaginable pain). Scores at 24 hours were not averaged with any other scores.
Measured: 24 hours postoperatively
Number of Participants With Increased Infusion Rates
Number of patients requiring increased infusion rates to 9 mL/hour to better optimize pain control.
Measured: Subjects will be followed postoperatively until postoperative day 2 (i.e. the discontinuation of the lumbar plexus catheters)
Number of Participants With Decreased Infusion Rates
Number of patient requiring decreased infusion rates decreased to 5 mL/hour due to increased motor blockade.
Measured: Subjects will be followed postoperatively until postoperative day 2 (i.e. the discontinuation of the lumbar plexus catheters)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2012 (estimated)
- Study startJan 2010
- Primary completionMay 2011
- Study completionDec 2014
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 (6)Papers the sponsor has linked to this study.
- Other trials for Total Hip ArthroplastyStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sylvia Wilson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sylvia Wilson, University of Pittsburgh
- Investigators
- Sylvia Wilson, MD, Principal investigator, University of Pittsburgh Medical CenterJacques E Chelly, MD, PhD, MBA, Study chair, University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01556724
- Sponsor's protocol ID
- PRO09090339
- Status last verified
- Dec 2017
- First submitted
- 6 Mar 2012
- Last updated
- 17 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Siddiqui ZI, Cepeda MS, Denman W, Schumann R, Carr DB. Continuous lumbar plexus block provides improved analgesia with fewer side effects compared with systemic opioids after hip arthroplasty: a randomized controlled trial. Reg Anesth Pain Med. 2007 Sep-Oct;32(5):393-8. doi: 10.1016/j.rapm.2007.04.008.
PubMed 17961837Marino J, Russo J, Kenny M, Herenstein R, Livote E, Chelly JE. Continuous lumbar plexus block for postoperative pain control after total hip arthroplasty. A randomized controlled trial. J Bone Joint Surg Am. 2009 Jan;91(1):29-37. doi: 10.2106/JBJS.H.00079.
PubMed 19122076Zink W, Graf BM. Local anesthetic myotoxicity. Reg Anesth Pain Med. 2004 Jul-Aug;29(4):333-40. doi: 10.1016/j.rapm.2004.02.008.
PubMed 15305253Leone S, Di Cianni S, Casati A, Fanelli G. Pharmacology, toxicology, and clinical use of new long acting local anesthetics, ropivacaine and levobupivacaine. Acta Biomed. 2008 Aug;79(2):92-105.
PubMed 18788503Paauwe JJ, Thomassen BJ, Weterings J, van Rossum E, Ausems ME. Femoral nerve block using ropivacaine 0.025%, 0.05% and 0.1%: effects on the rehabilitation programme following total knee arthroplasty: a pilot study. Anaesthesia. 2008 Sep;63(9):948-53. doi: 10.1111/j.1365-2044.2008.05538.x. Epub 2008 Jun 6.
PubMed 18540926de Leeuw MA, Dertinger JA, Hulshoff L, Hoeksema M, Perez RS, Zuurmond WW, de Lange JJ. The efficacy of levobupivacaine, ropivacaine, and bupivacaine for combined psoas compartment-sciatic nerve block in patients undergoing total hip arthroplasty. Pain Pract. 2008 Jul-Aug;8(4):241-7. doi: 10.1111/j.1533-2500.2008.00209.x. Epub 2008 May 23.
PubMed 18503623
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of 0.1 and 0.2% Ropivacaine in Lumbar Plexus Catheters After Primary Total Hip Arthroplasty: a Comparison of Postoperative Analgesia and Motor Function.
- ClinicalTrials.gov ID
- NCT01556724
- Acronym / sponsor ID
- PRO09090339
- Conditions
- Total Hip Arthroplasty, Postoperative Pain
- Keywords
- Peripheral nerve blocks, Ropivacaine concentrations in lumbar plexus catheters, Postoperative pain, Total hip replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Sylvia WilsonUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- May 2011 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 16 Mar 2012 (estimated)
- Results
- Posted 25 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Peripheral nerve blocks are the standard of care for pain management after hip replacement surgery at UPMC Shadyside. This prospective, randomized study is intended to assess the effect of 0.1 versus 0.2% ropivacaine in lumbar plexus nerve catheter infusions after total hip arthroplasty. Ropivacaine peripheral nerve block infusions have been utilized as the standard of care at UPMC Shadyside for many years. Ropivacaine, a less potent left-isomer of bupivacaine, is often used in place of bupivacaine due to less motor blockade and less severe cardiovascular and central nervous system potential toxicity.
The primary goal of this study to examine the effect of a low concentration infusion of ropivacaine (0.1%) on postoperative analgesia (evaluated by opioid consumption after 36 hours) compared with the standard accepted concentration of 0.2% ropivacaine in lumbar plexus catheters after primary total hip arthroplasty. Secondary goals are to examine motor function, VAS scores and patient satisfaction with pain control in low concentration 0.1% ropivacaine compared with 0.2% ropivacaine lumbar plexus infusions upto 36 hours after primary total hip arthroplasty.
Detailed description
Lumbar plexus catheters are the standard of care for postoperative pain management following total hip arthroplasty (THA) at UPMC Shadyside. The safety and efficacy of this technique has been demonstrated by multiple studies. Ropivacaine 0.2% was used for many years at UPMC Shadyside and throughout the UPMC system and this concentration of ropivacaine is the standard local anesthetic utilized by multiple other studies. However, this concentration of ropivacaine was later decreased to 0.1% in our institution in order to decrease patient's motor weakness and promote postoperative physical therapy. Patients were clinically observed to continue to have adequate postoperative analgesia while demonstrating improved motor function. A randomized, double blinded clinical trial has never compared 0.1 and 0.2% ropivacaine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.2% ropivacaine nerve block (standard of care) | Active comparator | Drug: 0.1% or 0.2% ropivacaine nerve blocks0.2% ropivacaine in lumbar plexus nerve catheter infusions for postoperative analgesia |
| 0.1% ropivacaine infusion in nerve block catheter | Experimental | Drug: 0.1% or 0.2% ropivacaine nerve blocks0.1% ropivacaine in lumbar plexus nerve catheter infusions |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18-75 years old
- American Society of Anesthesiologists physical status score I-III
- Scheduled for primary total hip arthroplasty at UPMC Shadyside Hospital in Pittsburgh, PA.
- No contraindications to peripheral nerve catheter placement
- Patients not expected to receive therapeutic anticoagulation in the postoperative period.
Key exclusion criteria (13 listed)
- Age under 18 years or older than 75 years.
- Any contraindication to a placement of continuous lumbar plexus peripheral nerve catheter.
- American Society of Anesthesiologist physical status IV or greater.
- Chronic painful conditions.
- Preoperative opioid tolerant use (opioid use for greater than 6 contiguous months before surgery).
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 |
|---|---|---|
| 0.1% or 0.2% ropivacaine nerve blocksAlso: Naropin (ropivacaine hcl)Either 0.1% or 0.2% ropivacaine will be infused at 7 mL/hr through lumbar plexus nerve block catheter based upon randomization, and can then receive a 6 ml bolus of either 0.1% or 0.2% ropivacaine. Additional pain relief will be available by nurse administered boluses of additional local anesthetic (from their randomized infusion) with a maximum dose of an extra 3 ml per bolus and limited to one bolus per hour. This bolus of their randomized local anesthetic will remain available until the nerve catheters are removed. Nerve block infusion rates may be increased to 9 ml/h for patients with increased pain without increased motor blockade as determined by the acute interventional perioperative pain service (AIPPS) or decreased to 5 ml/h for patients with increased motor blockade or weakness from the peripheral nerve block as determined by the AIPPS .All continuous lumbar plexus catheters will be removed on post operative day (POD) 2. | Drug | 0.1% ropivacaine infusion in nerve block catheter, 0.2% ropivacaine nerve block (standard of care) |
Primary outcome
Opiate Consumption Postoperatively
Time frame: 24 hours postoperatively
Postoperative opiate consumption at 24 hours
4 secondary outcomes
Patient Satisfaction With Pain Control
Time frame: 24 hours postoperatively
Numeric Rating Scale Pain Score With Movement at 24 Hours
Time frame: 24 hours postoperatively
Number of Participants With Increased Infusion Rates
Time frame: Subjects will be followed postoperatively until postoperative day 2 (i.e. the discontinuation of the lumbar plexus catheters)
Number of Participants With Decreased Infusion Rates
Time frame: Subjects will be followed postoperatively until postoperative day 2 (i.e. the discontinuation of the lumbar plexus catheters)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17961837Siddiqui ZI, Cepeda MS, Denman W, Schumann R, Carr DB. Continuous lumbar plexus block provides improved analgesia with fewer side effects compared with systemic opioids after hip arthroplasty: a randomized controlled trial. Reg Anesth Pain Med. 2007 Sep-Oct;32(5):393-8. doi: 10.1016/j.rapm.2007.04.008.
- Background: PubMed 19122076Marino J, Russo J, Kenny M, Herenstein R, Livote E, Chelly JE. Continuous lumbar plexus block for postoperative pain control after total hip arthroplasty. A randomized controlled trial. J Bone Joint Surg Am. 2009 Jan;91(1):29-37. doi: 10.2106/JBJS.H.00079.
- Background: PubMed 15305253Zink W, Graf BM. Local anesthetic myotoxicity. Reg Anesth Pain Med. 2004 Jul-Aug;29(4):333-40. doi: 10.1016/j.rapm.2004.02.008.
- Background: PubMed 18788503Leone S, Di Cianni S, Casati A, Fanelli G. Pharmacology, toxicology, and clinical use of new long acting local anesthetics, ropivacaine and levobupivacaine. Acta Biomed. 2008 Aug;79(2):92-105.
- Background: PubMed 18540926Paauwe JJ, Thomassen BJ, Weterings J, van Rossum E, Ausems ME. Femoral nerve block using ropivacaine 0.025%, 0.05% and 0.1%: effects on the rehabilitation programme following total knee arthroplasty: a pilot study. Anaesthesia. 2008 Sep;63(9):948-53. doi: 10.1111/j.1365-2044.2008.05538.x. Epub 2008 Jun 6.
- Background: PubMed 18503623de Leeuw MA, Dertinger JA, Hulshoff L, Hoeksema M, Perez RS, Zuurmond WW, de Lange JJ. The efficacy of levobupivacaine, ropivacaine, and bupivacaine for combined psoas compartment-sciatic nerve block in patients undergoing total hip arthroplasty. Pain Pract. 2008 Jul-Aug;8(4):241-7. doi: 10.1111/j.1533-2500.2008.00209.x. Epub 2008 May 23.
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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.
Sylvia Wilson, MD principal investigator
University of Pittsburgh Medical Center
Jacques E Chelly, MD, PhD, MBA study chair
University of Pittsburgh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0.1% or 0.2% ropivacaine nerve blocks in people with Total Hip Arthroplasty and Postoperative Pain, run by Sylvia Wilson 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 7 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 17 Jan 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Apr 2016). 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?
Opiate Consumption Postoperatively (time frame: 24 hours postoperatively). 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 NCT01556724, which also lists 6 linked publications.
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 17 Jan 2018.