Does Interneural Local Anesthetic Spread at the Site of Sciatic Nerve Bifurcation Shorten Block Onset Time?

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by University Health Network, Toronto.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01568476
First received: March 6, 2012
Last updated: March 29, 2012
Last verified: March 2012
  Purpose

Following foot and ankle surgery, ultrasound-guided sciatic nerve block (SNB) at the popliteal fossa decreases post-operative pain and opioid consumption. At the popliteal fossa, the sciatic nerve bifurcates to form the Common Peroneal Nerve (CPN) and Tibial Nerve (TN). Studies have shown that when both branches are blocked separately distal to the bifurcation site, block onset time is reduced by 30%. Through clinical observation, the investigators found that onset time is further shortened when ultrasound-guided SNB is performed at the site of bifurcation. This is because the local anesthetic spreads interneurally. The purpose of this study is to compare the block onset time of an ultrasound-guided sciatic nerve block at the site of nerve bifurcation with the blockade of each terminal nerve separately (TN and CPN) distal to sciatic nerve bifurcation.


Condition Intervention Phase
Post Operative Analgesia
Regional Anesthesia
Sciatic Nerve Block
Procedure: Distal
Procedure: Interneural
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Does Interneural Local Anesthetic Spread at the Site of Sciatic Nerve Bifurcation Shorten Block Onset Time?

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Block onset Time [ Time Frame: every 5 minutes up to 45 minutes of the block or until surgery starts ] [ Designated as safety issue: No ]
    We aim to compare the block onset time of an ultrasound-guided sciatic nerve block at the site of nerve bifurcation resulting in interneural spread of local anesthetic with that of blockade of each terminal nerve separately (TN and CPN), distal to sciatic nerve bifurcation. We hypothesize that sciatic nerve blockade at the site of bifurcation with interneural local anesthetic spread within a common epineural sheath results in shorter onset time compared to blockade of each terminal nerve distal to sciatic nerve bifurcation.


Secondary Outcome Measures:
  • Extent of longitudinal local anesthetic solution spread [ Time Frame: starting at block administration till 5 minutes after complete injection ] [ Designated as safety issue: No ]
  • Nerve diameter prior to and following injection [ Time Frame: starting at block administration till 5 minutes after complete injection ] [ Designated as safety issue: No ]
  • Block procedure time [ Time Frame: starting at block administration till complete injection(up to 10 minutes) ] [ Designated as safety issue: No ]
  • Number of skin punctures required. [ Time Frame: starting at first attempt of block administration till complete injection(up to 10 minutes) ] [ Designated as safety issue: No ]
  • Block success rate [ Time Frame: starting after complete injection up to 45 minutes ] [ Designated as safety issue: No ]
  • Incidence of block-related complications [ Time Frame: immediately , at 24 hours and Post operative day 7 ] [ Designated as safety issue: Yes ]
    Incidence of block-related complications (vascular puncture, hematoma formation, intravascular injection and post-operative neurologic deficit) will be documented, but due to the very low incidence in all block-related complications, this study is not powered to show a difference in safety

  • Postoperative pain [ Time Frame: starting at patient's arrival at post-anesthetic care unit till 120 minutes ] [ Designated as safety issue: No ]
    Postoperative pain: Postoperative pain using a verbal rating score (0-10, where 0= no pain, 10=excruciating pain) at 0, 30, 60, 90 and 120 min upon admission to post-anesthetic care unit.


Estimated Enrollment: 88
Study Start Date: July 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Distal
Blockade of both terminal branches of Sciatic nerve separately, distal to bifurcation
Procedure: Distal
Blockade of both terminal branches of Sciatic nerve separately, distal to bifurcation
Active Comparator: Interneural
sciatic nerve blockade at the site of bifurcation
Procedure: Interneural
Sciatic nerve blockade at the site of bifurcation

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA physical status I-III
  • 18-85 years of age, inclusive
  • 50-120 kg, inclusive
  • 150 cm of height or greater

Exclusion Criteria:

  • Contraindications to sciatic nerve block (e.g., allergy to local anesthetics, coagulopathy, malignancy or infection in the popliteal area)
  • Significant peripheral neuropathy or neurological disorder affecting the lower extremity
  • Pregnancy
  • History of alcohol or drug dependency/abuse
  • History of significant psychiatric conditions that may affect patient assessment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01568476

Contacts
Contact: Kris Abbas, M.D (416) 603-5800 ext 6237 KRIS.ABBAS@UHN.CA

Locations
Canada, Ontario
Toronto Western Hospital Recruiting
Toronto, Ontario, Canada, M5T 2S8
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Anahi Perlas, MD, FRCPC University of Toronto
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01568476     History of Changes
Other Study ID Numbers: 11-0059-A
Study First Received: March 6, 2012
Last Updated: March 29, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:
Regional anesthesia
Sciatic nerve block
foot surgery
ankle surgery
Interneural local anesthetic

Additional relevant MeSH terms:
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014