Optimizing Local Anesthetic Concentration for Continuous Lumbar Plexus Nerve Blocks

NCT00912873 | Completed Phase 4 Results

• 1 other identifier: Hip Concentration Study
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hip Arthroplasty; Hip Pain

Keywords

postoperative pain; perineural catheter; continuous peripheral nerve block; posterior lumbar plexus; hip surgery; psoas compartment; postoperative analgesia

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline in Quadriceps Femoris Maximum Voluntary Isometric Contraction (MVIC)

  Quadriceps femoris muscle strength evaluated using a portable, hand-held, isometric force dynamometer (MicroFET2, Lafayette Instrument Company, Lafayette, IN) to measure the maximum voluntary isometric contraction (MVIC) in a seated position. The study primary endpoint will be the difference in MVIC the morning following surgery compared with the preoperative MVIC, expressed as a percentage of the preoperative MVIC: (preop - postop ) / preop x 100.

  The study primary endpoint will be the difference in MVIC the morning following surgery compared with the preoperative MVIC, expressed as a percentage of the preoperative MVIC: (preop - postop ) / preop x 100.

Secondary Outcomes (6)

• Ambulation 100-foot Walking Test

  Day following surgery

• Total Ambulation

  Day following surgery

• Percent Change From Baseline in Hip Flexion

  Day following surgery

• Mean Resting Pain

  Day following surgery

• Average Dynamic Pain

  Day following surgery

Study Arms (2)

0.1% Ropivicaine

ACTIVE COMPARATOR

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: 0.1% Ropivacaine

0.4% Ropivicaine

EXPERIMENTAL

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: 0.4% Ropivacaine

Interventions

0.1% Ropivacaine DRUG

Ropivacaine 0.1% will be administered via the perineural catheter as follows: Basal Rate (12mL/h); Basal Dose (12 mg/h); Bolus Volume (4 mL); Bolus Dose (4 mg); Lockout Duration (30 min); Maximum Dose (20 mg/h)

0.1% Ropivicaine

0.4% Ropivacaine DRUG

Ropivacaine 0.1% will be administered via the perineural catheter as follows: Basal Rate (3 mL/h); Basal Dose (12 mg/h); Bolus Volume (1 mL); Bolus Dose (4 mg); Lockout Duration (30 min); Maximum Dose (20 mg/h)

0.4% Ropivicaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UCSD Medical Center

San Diego, California, 92103, United States

Location

Related Publications (1)

• Ilfeld BM, Moeller LK, Mariano ER, Loland VJ, Stevens-Lapsley JE, Fleisher AS, Girard PJ, Donohue MC, Ferguson EJ, Ball ST. Continuous peripheral nerve blocks: is local anesthetic dose the only factor, or do concentration and volume influence infusion effects as well? Anesthesiology. 2010 Feb;112(2):347-54. doi: 10.1097/ALN.0b013e3181ca4e5d.

  PMID: 20098137 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Brian Ilfeld, MD, MS
• Organization: University California San Diego

bilfeld@health.ucsd.edu

(858) 822-0776

Study Officials

• Brian M Ilfeld, M.D., M.S.

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, In Residence

Study Record Dates

• First Submitted: June 1, 2009
• First Posted: June 3, 2009
• Study Start: May 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: March 11, 2021
• Results First Posted: March 11, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)