Continuous Popliteal Nerve Blocks: Effect of Perineural Catheter Tip Location Relative to the Sciatic Nerve Bifurcation on Postoperative Analgesia

Phase 4

Completed

• Conditions: Ankle Surgery; Popliteal Nerve Block; Foot Surgery; Popliteal Bifurcation
• Interventions: Procedure: Catheter Placed 5cm Above Bifurcation; Procedure: Catheter Placed At Bifurcation

• Registration Number: NCT01229696
• Lead Sponsor: University of California, San Diego

Brief Summary

Research study to determine the relationship between perineural catheter tip location relative to the sciatic nerve bifurcation and postoperative analgesia for continuous popliteal nerve blocks.

Detailed Description

Hypothesis: During a continuous popliteal nerve block, postoperative analgesia will be improved with the perineural catheter tip at the level of the sciatic nerve bifurcation compared to when the catheter tip is 5 cm cephalad/proximal to the bifurcation.

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-27
• Study First Submitted QC: 2010-10-27
• Study First Posted: 2010-10-28
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-07
• Last Update Posted: 2016-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• undergoing surgery with a popliteal perineural catheter for postoperative analgesia
• age 18 years or older

Exclusion Criteria

• pregnancy
• inability to communicate with the investigators and hospital staff
• incarceration
• clinical neuropathy in the surgical extremity
• chronic high-dose opioid use
• a history of opioid abuse
• surgery outside of ipsilateral sciatic and saphenous nerve distributions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5cm Above Bifurcation	Catheter Placed 5cm Above Bifurcation	Patients randomized to this group will receive a sciatic nerve block placed 5cm above the bifurcaton of the sciatic nerve and outcome measures will be tested.
At Bifurcation	Catheter Placed At Bifurcation	Patients randomized to this group will receive a sciatic nerve block placed at the bifurcaton of the sciatic nerve and outcome measures will be tested.

Primary Outcome Measures

Name	Time	Method
Average Pain	1 Day following surgery	The average pain in the three hours previous to a phone call the day following surgery as measured on a numeric rating scale (0-10, 0=no pain, 10=worst imaginable pain).

Secondary Outcome Measures

Name	Time	Method
Satisfaction of pain control	1 day following surgery	Patients will give an answer on a 0-10 scale where 0=completely unsatisfied wiht pain control and 10=completely satisfied with pain control.
Infusion Side Effects	1 day following surgery	Numbness of foot and toes on a 0-10 scale where 0=no numbness and 10=complete numbness.
Sleep Disturbances	1 day following surgery	Total number of times patient woke due to pain the night following surgery.
Analgesic Use	1 day following surgery	Total oral opioid use since surgery and total IV analgesics if any.

Trial Locations

Locations (1)

UCSD Medical Centers (Hillcrest and Thornton); 🇺🇸 San Diego, California, United States