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

Foot Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01229696
• Other study ID #: Popliteal Bifurcation
• Status: Completed
• Phase: Phase 4
• First received: October 27, 2010
• Last updated: April 7, 2016
• Start date: October 2010
• Est. completion date: June 2015

Study information

• Verified date: April 2016
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankle Surgery
• Foot Surgery
• Popliteal Bifurcation
• Popliteal Nerve Block

Intervention

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
United States	UCSD Medical Centers (Hillcrest and Thornton)	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	Average Pain	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).	1 Day following surgery	No
Secondary	Analgesic Use	Total oral opioid use since surgery and total IV analgesics if any.	1 day following surgery	No
Secondary	Sleep Disturbances	Total number of times patient woke due to pain the night following surgery.	1 day following surgery	No
Secondary	Infusion Side Effects	Numbness of foot and toes on a 0-10 scale where 0=no numbness and 10=complete numbness.	1 day following surgery	No
Secondary	Satisfaction of pain control	Patients will give an answer on a 0-10 scale where 0=completely unsatisfied wiht pain control and 10=completely satisfied with pain control.	1 day following surgery	No