Overview

This trial is active, not recruiting.

Conditions total hip arthroplasty, postoperative pain
Treatment 0.1% or 0.2% ropivacaine nerve blocks
Sponsor University of Pittsburgh
Start date January 2010
End date May 2011
Trial size 41 participants
Trial identifier NCT01556724, PRO09090339

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
0.2% ropivacaine in lumbar plexus nerve catheter infusions for postoperative analgesia
0.1% or 0.2% ropivacaine nerve blocks Naropin (ropivacaine hcl)
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.
(Experimental)
0.1% ropivacaine in lumbar plexus nerve catheter infusions
0.1% or 0.2% ropivacaine nerve blocks Naropin (ropivacaine hcl)
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 Outcomes

Measure
Opiate consumption postoperatively
time frame: 24 hours postoperatively

Secondary Outcomes

Measure
Patient satisfaction with pain control
time frame: 24 hours postoperatively
NRS Pain Score
time frame: 24 hours postoperatively
Increased infusion rates
time frame: Subjects will be followed postoperatively until postoperative day 2 (i.e. the discontinuation of the lumbar plexus catheters)
Decreased infusion rates
time frame: Subjects will be followed postoperatively until postoperative day 2 (i.e. the discontinuation of the lumbar plexus catheters)

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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.

Additional Information

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.
Principal investigator Sylvia Wilson, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2013.
Information provided to ClinicalTrials.gov by University of Pittsburgh.