NCT01591603

Brief Summary

The study will investigate the difference in success rate between popliteal peripheral nerve catheters placed at 1 centimeter compared to 5 centimeters past the tip of a Tuohy needle.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
83

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

April 23, 2012

Completed
8 days until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 4, 2012

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

July 20, 2015

Status Verified

July 1, 2015

Enrollment Period

3.2 years

First QC Date

April 23, 2012

Last Update Submit

July 17, 2015

Conditions

Neuromuscular Inhibition

Outcome Measures

Primary Outcomes (1)

  • Change in Peripheral block score (PBS).

    The extent of popliteal nerve blockade will be captured with four sensory groups (sural, superficial peroneal, tibial, and deep peroneal) and three motor groups (superficial peroneal, tibial, and deep peroneal). For each group, a score of 0, 1, or 2 will be assigned based on complete, partial, or no blockade, respectively. The peripheral block score (PBS) outcome variable will be based on the sum of these values and will range from 0 to 14.

    10, 20, and 30 minutes after intervention

Secondary Outcomes (5)

  • Pain score

    Arrival to PACU (Immediately after surgery, approximately 3-5 hours after intervention)

  • Analgesia failure rate

    Arrival to PACU (Immediately after surgery, approximately 3-5 hours after intervention)

  • Catheter dislodgement rates

    Arrival to PACU (Immediately after surgery, approximately 3-5 hours after intervention)

  • Difference in total opioid usage

    Length of Stay In PACU (Approximately 5-7 hours after intervention)

  • Degree of Doppler color agitation

    Immediately after intervention

Study Arms (2)

Group 1

EXPERIMENTAL
Procedure: 1 cm

Group 2

EXPERIMENTAL
Procedure: 5 cm

Interventions

1 cmPROCEDURE

A Tuohy needle will be advanced in-plane with the bevel cephalad to a point that lies between the tibial and common peroneal branches of the sciatic nerve. The catheter will be advanced 1 cm past the tip of the Tuohy

Also known as: 18 gauge 100mm Contiplex Tuohy needle, 20-gauge non-stimulating catheter
Group 1
5 cmPROCEDURE

A Tuohy needle will be advanced in-plane with the bevel cephalad to a point that lies between the tibial and common peroneal branches of the sciatic nerve. The catheter will be advanced 5 cm past the tip of the Tuohy

Also known as: 18 gauge 100mm Contiplex Tuohy needle, 20-gauge non-stimulating catheter
Group 2

Eligibility Criteria

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

You may qualify if:

  • Will be having a popliteal nerve blocks

You may not qualify if:

  • \< 18 years old
  • BMI \> 35
  • Pregnant patients
  • Diabetes mellitus or patients with known neuropathy
  • Amputations \& polytrauma patients
  • Patients allergic to local anesthetics
  • Chronic Pain patients
  • Patients in whom communication is a problem

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

  • Bowens C Jr, Badiola IJ, Allen BFS, Canlas CL, Gupta RK, Jaeger LM, Briggs ER, Corey JM, Shi Y, Schildcrout JS, Malchow RJ. Color Doppler ultrasonography of an agitated solution is predictive of accurate catheter placement for a continuous popliteal sciatic nerve block. Perioper Med (Lond). 2021 Dec 15;10(1):59. doi: 10.1186/s13741-021-00229-w.

    PMID: 34906248DERIVED

Study Officials

  • Clifford Bowens, M.D.

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 23, 2012

First Posted

May 4, 2012

Study Start

May 1, 2012

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

July 20, 2015

Record last verified: 2015-07

Locations

US(1)