A Comparison of Postoperative Analgesic Nerve Block Ropivacaine Concentrations

Postoperative Pain Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01556724
• Other study ID #: PRO09090339
• Status: Completed
• Phase: N/A
• First received: March 6, 2012
• Last updated: December 18, 2017
• Start date: January 2010
• Est. completion date: December 2014

Study information

• Verified date: December 2017
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: December 2014
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain
• Total Hip Arthroplasty

Intervention

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.

Locations

Country	Name	City	State
United States	UPMC Presbyterian Shadyside	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Sylvia Wilson

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. Review. — View 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. — View 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. — View 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. — View Citation

Zink W, Graf BM. Local anesthetic myotoxicity. Reg Anesth Pain Med. 2004 Jul-Aug;29(4):333-40. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opiate Consumption Postoperatively	Postoperative opiate consumption at 24 hours	24 hours postoperatively
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.	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.	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.	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.	Subjects will be followed postoperatively until postoperative day 2 (i.e. the discontinuation of the lumbar plexus catheters)