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A Comparison of Postoperative Analgesic Nerve Block Ropivacaine Concentrations

Primary Purpose

Total Hip Arthroplasty, Postoperative Pain

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

0.1% or 0.2% ropivacaine nerve blocks

About this trial

This is an interventional treatment trial for Total Hip Arthroplasty focused on measuring Peripheral nerve blocks, Ropivacaine concentrations in lumbar plexus catheters, Postoperative pain, Total hip replacement

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

UPMC Presbyterian Shadyside

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

0.2% ropivacaine nerve block (standard of care)

0.1% ropivacaine infusion in nerve block catheter

Arm Description

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

0.1% ropivacaine in lumbar plexus nerve catheter infusions

Outcomes

Primary Outcome Measures

Opiate Consumption Postoperatively

Postoperative opiate consumption at 24 hours

Secondary Outcome Measures

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.

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.

Number of Participants With Increased Infusion Rates

Number of patients requiring increased infusion rates to 9 mL/hour to better optimize pain control.

Number of Participants With Decreased Infusion Rates

Number of patient requiring decreased infusion rates decreased to 5 mL/hour due to increased motor blockade.

Full Information

NCT ID

NCT01556724

First Posted

March 6, 2012

Last Updated

December 18, 2017

Sponsor

Sylvia Wilson

1. Study Identification

Unique Protocol Identification Number

NCT01556724

Brief Title

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

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

May 2011 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Sylvia Wilson

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Total Hip Arthroplasty, Postoperative Pain

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

41 (Actual)

8. Arms, Groups, and Interventions

Arm Title

0.2% ropivacaine nerve block (standard of care)

Arm Type

Active Comparator

Arm Description

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

Arm Title

0.1% ropivacaine infusion in nerve block catheter

Arm Type

Experimental

Arm Description

0.1% ropivacaine in lumbar plexus nerve catheter infusions

Intervention Type

Drug

Intervention Name(s)

0.1% or 0.2% ropivacaine nerve blocks

Other Intervention Name(s)

Naropin (ropivacaine hcl)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Opiate Consumption Postoperatively

Description

Postoperative opiate consumption at 24 hours

Time Frame

24 hours postoperatively

Secondary Outcome Measure Information:

Title

Patient Satisfaction With Pain Control

Description

Time Frame

24 hours postoperatively

Title

Numeric Rating Scale Pain Score With Movement at 24 Hours

Description

Time Frame

24 hours postoperatively

Title

Number of Participants With Increased Infusion Rates

Description

Number of patients requiring increased infusion rates to 9 mL/hour to better optimize pain control.

Time Frame

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

Title

Number of Participants With Decreased Infusion Rates

Description

Number of patient requiring decreased infusion rates decreased to 5 mL/hour due to increased motor blockade.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sylvia Wilson, MD

Organizational Affiliation

University of Pittsburgh Medical Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jacques E Chelly, MD, PhD, MBA

Organizational Affiliation

University of Pittsburgh Medical Center

Official's Role

Study Chair

Facility Information:

Facility Name

UPMC Presbyterian Shadyside

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15232

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

17961837

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.

Results Reference

background

PubMed Identifier

19122076

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.

Results Reference

background

PubMed Identifier

15305253

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.

Results Reference

background

PubMed Identifier

18788503

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.

Results Reference

background

PubMed Identifier

18540926

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.

Results Reference

background

PubMed Identifier

18503623

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.

Results Reference

background

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A Comparison of Postoperative Analgesic Nerve Block Ropivacaine Concentrations

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