NCT01325012

Brief Summary

To determine the relationship between perineural catheter location along the sciatic nerve (popliteal versus subgluteal placement) and infusion effects for ultrasound-guided continuous sciatic nerve blocks.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

March 28, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 29, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

March 29, 2013

Status Verified

March 1, 2013

Enrollment Period

2 years

First QC Date

March 28, 2011

Last Update Submit

March 27, 2013

Conditions

Foot Surgery

Keywords

PainSurgeryCatheterNerve BlockPoplitealSubglutealSciaticUCSDModerate-to-severe painPerineural CatheterOrthopedic Surgeryfoot surgery surgerysciatic perineural catheterage =>18

Outcome Measures

Primary Outcomes (1)

  • Muscle Strength (MVIC) of the hamstring muscles

    We will evaluate hamstring strength which is innervated by the sciatic nerve with an isometric force electromechanical dynamometer to measure the force produced during a maximum voluntary isometric contraction (MVIC) in a seated position with the knees flexed at 90º

    08:00-09:00 morning after surgery as a percentage of baseline

Secondary Outcomes (6)

  • Sensory Effect

    08:00-09:00 morning after surgery

  • Pain Scores

    from leaving the PACU until 08:00 the morning after surgery

  • Sleep Disturbances

    recorded at 08:00-09:00 the morning after surgery for the previous night

  • Total Infusion

    recorded at 08:00-09:00 the morning following Surgery

  • Anesthetic Leakage

    recorded at 08:00-09:00 the morning following Surgery

  • +1 more secondary outcomes

Study Arms (2)

Subgluteal Sciatic Nerve Block

ACTIVE COMPARATOR

Patients randomized to this group will receive a sciatic nerve block with the catheter tip insertion at the subgluteal location 1-3 cm caudad to the inferior border of the gluteus maximus muscle.

Procedure: Subgluteal Sciatic Nerve Block

Popliteal Sciatic Nerve Block

ACTIVE COMPARATOR

Patients randomized to this group will receive a sciatic nerve block with the catheter tip insertion at the popliteal location 1-3 cm cephalad to the sciatic bifurcation.

Procedure: Popliteal Sciatic Nerve Block

Interventions

Subgluteal Sciatic Nerve BlockPROCEDURE

Patients randomized to this group will receive a sciatic nerve block with the catheter tip insertion at the subgluteal location 1-3 cm caudad to the inferior border of the gluteus maximus muscle. After catheter placement, outcome measures will be assessed.

Subgluteal Sciatic Nerve Block
Popliteal Sciatic Nerve BlockPROCEDURE

Patients randomized to this group will receive a sciatic nerve block with the catheter tip insertion at the popliteal location 1-3 cm cephalad to the sciatic bifurcation. After Catheter placement outcome measures will be assessed.

Popliteal Sciatic Nerve Block

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • undergoing foot surgery with a sciatic perineural catheter for postoperative analgesia
  • spending the first postoperative night hospitalized
  • age 18 years or older

You may not qualify if:

  • pregnancy
  • inability to communicate with the investigators and hospital staff
  • incarceration
  • clinical neuropathy in the surgical extremity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UCSD Medical Center, Thornton

La Jolla, California, United States

Location

UCSD Medical Center Hillcrest

San Diego, California, 92103, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Brian M Ilfeld, M.D., M.S.

    University of California, Department of Anesthesiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, In Residence

Study Record Dates

First Submitted

March 28, 2011

First Posted

March 29, 2011

Study Start

March 1, 2011

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

March 29, 2013

Record last verified: 2013-03

Locations

US(2)