Clinical trial NCT01643616: Ultrasound Guided Distal Sciatic Nerve Block - a Comparison With Nerve Stimulator Technique
Official title: Ultrasound Guided Distal Sciatic Nerve Block - a Randomised Comparison With Nerve Stimulator Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Other Surgical Procedures
Keywords: Sciatic Nerve
Ultrasound
Anesthesia, Regional
Orthopedic Surgery
Lead sponsor: Helios Research Center
Sponsor class: OTHER
First posted: 2012-07-18
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: For distal sciatic nerve block this prospective, randomised comparison with ultrasound guided distal subepineural block tested the hypothesis, that intraepineural injection of local anesthetic using nerve stimulation technique is common and associated with high success rate.

Detailed description: Classical methods for nerve localization (loss of resistance, cause of paresthesias, nerve stimulation technique)assumed that the target is a close approximation to the nerve, without epineural perforation. Intraneural injections were considered as evitable, with high risk for nerve damages.

Ultrasound guidance provided for the first time a real-time visualization of the spread of local anesthetic. Some recent studies proved, that an intraneural injection using nerve stimulator technique is common and not necessarily accompanied with nerve damages.

In the ultrasound group (group US) the investigators tested the hypothesis, that an intraneural injection of local anesthetic generate a high success rate and a short onset time without clinical apparent nerve damages.

In the nerve-stimulation group (group NS) the investigators tested the hypothesis, that an intraneural injection of local anesthetic is common, and in case of intraneural injection accompanied likewise with high success rate and shorter onset time.

For the sciatic division the investigators tested the hypothesis, that classical methods of nerve localization (nerve-stimulation technique, cause of paresthesias) are not able to avoid epineural perforation.

Eligibility criteria: Inclusion Criteria:

* elective surgery on the foot or ankle
* tourniquet distal of the knee
* adult patients, 18-75 years old
* ASA-risk-groups I-III (American Society of Anesthesiologists)
* informed consent

Exclusion Criteria:

* severe coagulopathy
* systemic inflammatory response
* ASA-risk-groups \> III (American Society of Anesthesiologists)
* drug allergy: local anesthetics
* pregnancy, lactation period
* participation in other studies
* addiction to drugs or alcohol
* non-cooperative patients

Primary outcomes:
measure: Success Rate Without Supplementation
timeFrame: within 30-60 minutes after injection of the local anesthetic
measure: Time Until Readiness for Surgery (Minutes)
timeFrame: within 60 minutes after injection of the local anesthetic
measure: Success Rate With Supplementation
timeFrame: later than 30-60 minutes after injection of the local anesthetic
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Klinik für Anästhesiologie und Intensivtherapie, Helios Kliniken Schwerin, Wismarsche Strasse 393-7, DE-19049 Schwerin
name: Ronald Seidel, Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinik für Anästhesiologie und Intensivtherapie, Helios Kliniken Schwerin, Wismarsche Strasse 393-7, DE-19049 Schwerin
name: Georg Rehmert, Dr. med.
role: STUDY_DIRECTOR
References: