A Comparison of Postoperative Analgesic Nerve Block Ropivacaine Concentrations

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sylvia Wilson, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01556724
First received: March 6, 2012
Last updated: July 21, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Total Hip Arthroplasty
Postoperative Pain
Drug: 0.1% or 0.2% ropivacaine nerve blocks

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Opiate consumption postoperatively [ Time Frame: 24 hours postoperatively ] [ Designated as safety issue: No ]
    Postoperative opiate consumption at 24 hours


Secondary Outcome Measures:
  • Patient satisfaction with pain control [ Time Frame: 24 hours postoperatively ] [ Designated as safety issue: No ]
    Patient satisfaction with pain control at 24 hours (0-10 scale)

  • NRS Pain Score [ Time Frame: 24 hours postoperatively ] [ Designated as safety issue: No ]
    Pain scores (VAS; at rest and with physical therapy; 0-10) at 24 hours postoperative

  • Increased infusion rates [ Time Frame: Subjects will be followed postoperatively until postoperative day 2 (i.e. the discontinuation of the lumbar plexus catheters) ] [ Designated as safety issue: No ]
    Number of patients requiring increased infusion rates to better optimize pain control

  • Decreased infusion rates [ Time Frame: Subjects will be followed postoperatively until postoperative day 2 (i.e. the discontinuation of the lumbar plexus catheters) ] [ Designated as safety issue: No ]
    Number of patient requiring decreased infusion rates due to increased motor blockade


Enrollment: 41
Study Start Date: January 2010
Estimated Study Completion Date: December 2014
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 0.2% ropivacaine nerve block (standard of care)
0.2% ropivacaine in lumbar plexus nerve catheter infusions for postoperative analgesia
Drug: 0.1% or 0.2% ropivacaine nerve blocks
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.
Other Name: Naropin (ropivacaine hcl)
Experimental: 0.1% ropivacaine infusion in nerve block catheter
0.1% ropivacaine in lumbar plexus nerve catheter infusions
Drug: 0.1% or 0.2% ropivacaine nerve blocks
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.
Other Name: Naropin (ropivacaine hcl)

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01556724

Locations
United States, Pennsylvania
UPMC Presbyterian Shadyside
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Sylvia Wilson, MD University of Pittsburgh
Study Chair: Jacques E Chelly, MD, PhD, MBA University of Pittsburgh
  More Information

Publications:
Responsible Party: Sylvia Wilson, Regional Anesthesia Fellow, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01556724     History of Changes
Other Study ID Numbers: PRO09090339
Study First Received: March 6, 2012
Last Updated: July 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Peripheral nerve blocks
Ropivacaine concentrations in lumbar plexus catheters
Postoperative pain
Total hip replacement

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014