Optimizing Local Anesthetic Concentration for Continuous Lumbar Plexus Nerve Blocks
This study has been completed.
Sponsor:
University of California, San Diego
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
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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
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, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions |
Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013