A Comparison of Postoperative Analgesic Nerve Block Ropivacaine Concentrations

NCT01556724 | Completed Results

• 1 other identifier: PRO09090339
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Hip Arthroplasty; Postoperative Pain

Keywords

Peripheral nerve blocks; Ropivacaine concentrations in lumbar plexus catheters; Postoperative pain; Total hip replacement

Outcome Measures

Primary Outcomes (1)

• Opiate Consumption Postoperatively

  Postoperative opiate consumption at 24 hours

  24 hours postoperatively

Secondary Outcomes (4)

• Patient Satisfaction With Pain Control

  24 hours postoperatively

• Numeric Rating Scale Pain Score With Movement at 24 Hours

  24 hours postoperatively

• Number of Participants With Increased Infusion Rates

  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

  Subjects will be followed postoperatively until postoperative day 2 (i.e. the discontinuation of the lumbar plexus catheters)

Study Arms (2)

0.2% ropivacaine nerve block (standard of care)

ACTIVE COMPARATOR

0.2% ropivacaine in lumbar plexus nerve catheter infusions for postoperative analgesia

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

Drug: 0.1% or 0.2% ropivacaine nerve blocks

Interventions

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.

Also known as: Naropin (ropivacaine hcl)

0.1% ropivacaine infusion in nerve block catheter; 0.2% ropivacaine nerve block (standard of care)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sylvia Wilson: lead

Study Sites (1)

UPMC Presbyterian Shadyside

Pittsburgh, Pennsylvania, 15232, United States

Location

Related Publications (6)

• 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.

  PMID: 17961837 BACKGROUND

• 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.

  PMID: 19122076 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.

  PMID: 15305253 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.

  PMID: 18788503 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.

  PMID: 18540926 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.

  PMID: 18503623 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Susan Sandusky
• Organization: University of Pittsburgh

sis127@pitt.edu

412-383-1036

Study Officials

• Sylvia Wilson, MD

  University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

• Jacques E Chelly, MD, PhD, MBA

  University of Pittsburgh Medical Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Regional Anesthesia Fellow

Study Record Dates

• First Submitted: March 6, 2012
• First Posted: March 16, 2012
• Study Start: January 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: December 1, 2014
• Last Updated: January 17, 2018
• Results First Posted: April 25, 2016

Record last verified: 2017-12

Locations

US (1)