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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.2% ropivacaine nerve block (standard of care) | Active Comparator | 0.2% ropivacaine in lumbar plexus nerve catheter infusions for postoperative analgesia |
|
| 0.1% ropivacaine infusion in nerve block catheter | Experimental | 0.1% ropivacaine in lumbar plexus nerve catheter infusions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.1% or 0.2% ropivacaine nerve blocks | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Opiate Consumption Postoperatively | Postoperative opiate consumption at 24 hours | 24 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 hours postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sylvia Wilson, MD | University of Pittsburgh Medical Center | Principal Investigator |
| Jacques E Chelly, MD, PhD, MBA | University of Pittsburgh Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Presbyterian Shadyside | Pittsburgh | Pennsylvania | 15232 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17961837 | Background | 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. | |
| 19122076 | Background |
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Forty-one patients signed an informed consent form. Eleven patients were excluded: six for inability to achieve <0.5mA quadriceps stimulation for lumbar plexus block placement and five for general anesthesia. After pharmacy randomization, 14 received ropivacaine 0.1% and 16 received ropivacaine 0.2%.
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| ID | Title | Description |
|---|---|---|
| FG000 | 0.2% Ropivacaine | 0.2% ropivacaine 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. |
| FG001 | 0.1% Ropivacaine | 0.1% ropivacaine 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 0.2% Ropivacaine | 0.2% ropivacaine 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Opiate Consumption Postoperatively | Postoperative opiate consumption at 24 hours | Forty-one patients signed informed consent and underwent primary THA. Eleven patients were excluded: six for inability to achieve <0.5mA quadriceps stimulation for lumbar plexus block and five for general anesthesia. The study was completed after pharmacy randomization 30 patients: 16 in 0.2% and 14 in 0.1% group. | Posted | Mean | 95% Confidence Interval | mg | 24 hours postoperatively |
|
Adverse event were analyzed after lumbar plexus perineural catheter removal on POD2 as this was the end of the data collection period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 0.2% Ropivacaine | 0.2% ropivacaine 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Susan Sandusky | University of Pittsburgh | 412-383-1036 | sis127@pitt.edu |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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|
|
| 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. |
| 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. | 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. | Subjects will be followed postoperatively until postoperative day 2 (i.e. the discontinuation of the lumbar plexus catheters) |
| Marino 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. |
| 15305253 | Background | Zink 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. |
| 18788503 | Background | Leone 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. |
| 18540926 | Background | Paauwe 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. |
| 18503623 | Background | de 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. |
| BG001 | 0.1% Ropivacaine | 0.1% ropivacaine 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 0.1% Ropivacaine | 0.1% ropivacaine 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. |
|
|
| Secondary | 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. | Patient satisfaction with pain control at 24 hours. | Posted | Median | 95% Confidence Interval | units on a scale | 24 hours postoperatively |
|
|
|
| Secondary | 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. | NRS pain scores at 24 hours postoperatively at rest and in movement. | Posted | Median | 95% Confidence Interval | units on a scale | 24 hours postoperatively |
|
|
|
| Secondary | Number of Participants With Increased Infusion Rates | Number of patients requiring increased infusion rates to 9 mL/hour to better optimize pain control. | The number of participants with requiring increased infusion rates. | Posted | Count of Participants | Participants | Subjects will be followed postoperatively until postoperative day 2 (i.e. the discontinuation of the lumbar plexus catheters) |
|
|
|
| Secondary | Number of Participants With Decreased Infusion Rates | Number of patient requiring decreased infusion rates decreased to 5 mL/hour due to increased motor blockade. | Number of patient requiring decreased infusion rates. | Posted | Count of Participants | Participants | Subjects will be followed postoperatively until postoperative day 2 (i.e. the discontinuation of the lumbar plexus catheters) |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | 0.1% Ropivacaine Infusion in Nerve Block Catheter | 0.1% ropivacaine 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. | 0 | 14 | 0 | 14 | 0 | 14 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |