Ultrasound-Guided Continuous Sciatic Nerve Blocks: Popliteal Versus Subgluteal Catheters

Phase 4

Terminated

• Conditions: Foot Surgery
• Interventions: Procedure: Subgluteal Sciatic Nerve Block; Procedure: Popliteal Sciatic Nerve Block

• Registration Number: NCT01325012
• Lead Sponsor: University of California, San Diego

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-03-28
• Study First Submitted QC: 2011-03-28
• Study First Posted: 2011-03-29
• Status Verified: 2013-03
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Last Update Submitted: 2013-03-27
• Last Update Posted: 2013-03-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Subgluteal Sciatic Nerve Block	Subgluteal Sciatic Nerve Block	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.
Popliteal Sciatic Nerve Block	Popliteal Sciatic Nerve Block	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.

Primary Outcome Measures

Name	Time	Method
Muscle Strength (MVIC) of the hamstring muscles	08:00-09:00 morning after surgery as a percentage of baseline	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

Secondary Outcome Measures

Name	Time	Method
Sensory Effect	08:00-09:00 morning after surgery	We will evaluate tolerance of transcutaneous electrical stimulation. Electrocardiogram pads will be placed on the plantar and dorsal aspects of the foot, and attached to a nerve stimulator. The current will be increased from 0 mA until subjects described a "buzzing" sensation (not painful), at which time the current will be recorded as the tolerated level and the nerve stimulator turned off.
Pain Scores	from leaving the PACU until 08:00 the morning after surgery	Surgical pain scores both average and worse as collected by nursing staff; and also the average and worse pain during the primary endpoint measurement
Sleep Disturbances	recorded at 08:00-09:00 the morning after surgery for the previous night	Total number of times patient woke in the night due to surgical pain.
Total Infusion	recorded at 08:00-09:00 the morning following Surgery	Total infusiond duration in time and volume and total number of boluses delivered via catheter.
Anesthetic Leakage	recorded at 08:00-09:00 the morning following Surgery	Leakage from the catheter site noted by patient.
analgesic consumption	end of PACU stay until 08:00-09:00 the morning following surgery	Hourly analgesic consumption.

Trial Locations

Locations (2)

UCSD Medical Center, Thornton; 🇺🇸 La Jolla, California, United States

UCSD Medical Center Hillcrest; 🇺🇸 San Diego, California, United States