Clinical trial NCT01556724: A Comparison of Postoperative Analgesic Nerve Block Ropivacaine Concentrations
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Hip Arthroplasty
Postoperative Pain
Keywords: Peripheral nerve blocks
Ropivacaine concentrations in lumbar plexus catheters
Postoperative pain
Total hip replacement
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2012-03-16
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Opiate Consumption Postoperatively
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Patient Satisfaction With Pain Control
timeFrame: 24 hours postoperatively
measure: Numeric Rating Scale Pain Score With Movement at 24 Hours
timeFrame: 24 hours postoperatively
measure: Number of Participants With Increased Infusion Rates
timeFrame: Subjects will be followed postoperatively until postoperative day 2 (i.e. the discontinuation of the lumbar plexus catheters)
measure: Number of Participants With Decreased Infusion Rates
timeFrame: Subjects will be followed postoperatively until postoperative day 2 (i.e. the discontinuation of the lumbar plexus catheters)
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Presbyterian Shadyside
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh Medical Center
name: Sylvia Wilson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh Medical Center
name: Jacques E Chelly, MD, PhD, MBA
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.