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

Foot Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01325012
• Other study ID #: Subgluteal vs Popliteal
• Status: Terminated
• Phase: Phase 4
• First received: March 28, 2011
• Last updated: March 27, 2013
• Start date: March 2011
• Est. completion date: March 2013

Study information

• Verified date: March 2013
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Foot Surgery

Intervention

Procedure:
• 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. After catheter placement, outcome measures will be assessed.
• 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. After Catheter placement outcome measures will be assessed.

Locations

Country	Name	City	State
United States	UCSD Medical Center, Thornton	La Jolla	California
United States	UCSD Medical Center Hillcrest	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Sensory Effect	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.	08:00-09:00 morning after surgery	No
Secondary	Pain Scores	Surgical pain scores both average and worse as collected by nursing staff; and also the average and worse pain during the primary endpoint measurement	from leaving the PACU until 08:00 the morning after surgery	No
Secondary	Sleep Disturbances	Total number of times patient woke in the night due to surgical pain.	recorded at 08:00-09:00 the morning after surgery for the previous night	No
Secondary	Total Infusion	Total infusiond duration in time and volume and total number of boluses delivered via catheter.	recorded at 08:00-09:00 the morning following Surgery	No
Secondary	Anesthetic Leakage	Leakage from the catheter site noted by patient.	recorded at 08:00-09:00 the morning following Surgery	No
Secondary	analgesic consumption	Hourly analgesic consumption.	end of PACU stay until 08:00-09:00 the morning following surgery	No