Optimizing Local Anesthetic Concentration for Continuous Lumbar Plexus Nerve Blocks

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Brian M. Ilfeld, MD, MS, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00912873
First received: June 1, 2009
Last updated: June 18, 2012
Last verified: June 2012
  Purpose

This is a research study to determine if the concentration of local anesthetic through a catheter next to the nerves that go to the hip that is undergoing surgery, affects muscle strength and sense of touch experienced after surgery. This study is looking at the varying concentrations of local anesthetic placed through the catheter.


Condition Intervention Phase
Hip Arthroplasty
Hip Pain
Drug: ropivicaine (Psoas compartment block)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Optimizing Local Anesthetic Concentration for Continuous Lumbar Plexus Nerve Blocks

Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Quadriceps femoris muscle strength, by measuring the maximum voluntary isometric contraction (MVIC). The difference in MVIC on POD1 compared with the preoperative MVIC, expressed as a percentage of the preoperative MVIC. [ Time Frame: change between two time points: baseline (Immediately prior to surgery) and postoperative day 2 (morning following surgery between 8:30-10:30) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hip adductor strength, evaluated in sitting position using the same technique as described for the primary outcome measure. [ Time Frame: change between two time points: baseline (Immediately prior to surgery) and postoperative day 2 (morning following surgery between 8:30-10:30) ] [ Designated as safety issue: No ]
  • Hip flexor strength, evaluated in the supine position using the same technique as described for the primary outcome measure. [ Time Frame: change between two time points: baseline (Immediately prior to surgery) and postoperative day 2 (morning following surgery between 8:30-10:30) ] [ Designated as safety issue: No ]
  • Sensory level, evaluated in the seated position, the current through TES is increased from 0mV until the patient describes mild discomfort and the current is then recorded. [ Time Frame: change between two time points: baseline (Immediately prior to surgery) and postoperative day 2 (morning following surgery between 8:30-10:30) ] [ Designated as safety issue: No ]
  • Ambulatory ability, evaluated using the 100-foot walk test and the six minute walk test. Afer patients walk 100 feet, they will continue to walk for six minutes and the total distance will be recorded. [ Time Frame: change between two time points: baseline (Immediately prior to surgery) and postoperative day 2 (morning following surgery between 8:30-10:30) ] [ Designated as safety issue: No ]
  • Range of motion, evaluated using a standard goniometer for hip flexion within precaution limits. [ Time Frame: change between two time points: baseline (Immediately prior to surgery) and postoperative day 2 (morning following surgery between 8:30-10:30) ] [ Designated as safety issue: No ]
  • Weight bearing, evaluated using a standard scale to demonstrate the correct amount of weight to place on an operative extremity. [ Time Frame: change between two time points: baseline (Immediately prior to surgery) and postoperative day 2 (morning following surgery between 8:30-10:30) ] [ Designated as safety issue: No ]
  • Pain, evaluated using a verbal rating scale of 0-10, where 0=no pain and 10=worst imaginable pain. [ Time Frame: change between two time points: baseline (Immediately prior to surgery) and postoperative day 2 (morning following surgery between 8:30-10:30) ] [ Designated as safety issue: No ]
    Average of all pain scores (other than during physical therapy)


Enrollment: 56
Study Start Date: May 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1. 0.1% Ropivicaine
Patients will be given 0.1% ropivicaine provided via infusion pump which will be attached intraoperatively and will remain connected until patient is ready to leave the hospital. In this time a physical therapist will work with the patient to assess outcome measures.
Drug: ropivicaine (Psoas compartment block)
Patients will be randomized to one of two groups: ropivicaine 0.1% infusion or ropivicaine 0.4% infusion. The infusion rate will be set at 12mL/hour and 3mL/hour respectively and the outcome measures will be assessed by physical therapy using the described methods.
Experimental: 2. 0.4% Ropivicaine
Patients will be given 0.4% ropivicaine provided via infusion pump which will be attached intraoperatively and will remain connected until patient is ready to leave the hospital. In this time a physical therapist will work with the patient to assess outcome measures.
Drug: ropivicaine (Psoas compartment block)
Patients will be randomized to one of two groups: ropivicaine 0.1% infusion or ropivicaine 0.4% infusion. The infusion rate will be set at 12mL/hour and 3mL/hour respectively and the outcome measures will be assessed by physical therapy using the described methods.

Detailed Description:

These results will help define the optimal concentration of local anesthetic used for continuous peripheral nerve blocks and help guide future research in this clinically-relevant area.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary, unilateral hip arthroplasty
  • age greater than or equal to 18 years
  • postoperative analgesic plan includes perineural local anesthetic infusion

Exclusion Criteria:

  • morbid obesity as defined by a body mass index greater than 40
  • chronic high dose opioid use
  • history of opioid abuse
  • neuro-muscular deficit of the ipsilateral femoral nerve and/or quadriceps muscle
  • vulnerable populations i.e., children, pregnant women, or prisoners
  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: NCT00912873

Locations
United States, California
UCSD Medical Center
San Diego, California, United States, 92103
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Brian M Ilfeld, M.D., M.S. University of California, San Diego
  More Information

No publications provided

Responsible Party: Brian M. Ilfeld, MD, MS, Associate Professor, In Residence, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00912873     History of Changes
Other Study ID Numbers: Hip Concentration Study
Study First Received: June 1, 2009
Last Updated: June 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
pain
catheter
nerve block
UCSD
range of motion
hip surgery
psoas compartment
Range of Motion

Additional relevant MeSH terms:
Anesthetics
Anesthetics, Local
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014