Ultrasound Guided Distal Sciatic Nerve Block - a Comparison With Nerve Stimulator Technique

NCT01643616 | Completed Results

• 1 other identifier: HV 2010 003
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Other Surgical Procedures

Keywords

Sciatic Nerve; Ultrasound; Anesthesia, Regional; Orthopedic Surgery

Outcome Measures

Primary Outcomes (3)

• Success Rate Without Supplementation

  After injection of local anesthetic a waiting period of 30-60 minutes was defined before completing a failed block. 1. success without supplementation = no additional analgetics or rescue blocks required (success rate without supplementation, outcome measure 1) 2. success with supplementation = analgetics or selective rescue blocks distal of the sciatic division required (success rate without supplementation and additionally all supplemented blocks, outcome measure 3) 3. failed block = change of anesthetic procedure (general, spinal) or rescue blocks proximal of the sciatic division

  within 30-60 minutes after injection of the local anesthetic

• Time Until Readiness for Surgery (Minutes)

  within 60 minutes after injection of the local anesthetic

• Success Rate With Supplementation

  After injection of local anesthetic a waiting period of 30-60 minutes was defined before completing a failed block. 1. success without supplementation = no additional analgetics or rescue blocks required (success rate without supplementation, outcome measure 1) 2. success with supplementation = analgetics or selective rescue blocks distal of the sciatic division required (success rate without supplementation and additionally all supplemented blocks, outcome measure 3) 3. failed block = change of anesthetic procedure (general, spinal) or rescue blocks proximal of the sciatic divisionSucces rate with supplementation

  later than 30-60 minutes after injection of the local anesthetic

Study Arms (2)

group US

ACTIVE COMPARATOR

Ultrasound guided block : 20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)

Drug: midazolam; Drug: Prilocaine 1%; Drug: Ropivacaine 0.75%; Device: ultrasound guidance

group NS

ACTIVE COMPARATOR

Nerve stimulation technique: 20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)

Drug: midazolam; Drug: Prilocaine 1%; Drug: Ropivacaine 0.75%; Device: nerve stimulation technique

Interventions

midazolam DRUG

Prior to performing the regional anesthesia the investigators administered midazolam as a premedication by mouth (3,75-7,5mg) or intravenously (2-3mg).

Also known as: Dormicum

group NS; group US

Prilocaine 1% DRUG

20ml Prilocaine 1% for distal sciatic nerve block (30ml Prilocaine 1% in outpatients)

Also known as: Xylonest

group NS; group US

Ropivacaine 0.75% DRUG

10ml Ropivacaine 0.75% for distal sciatic nerve block (not in outpatients)

Also known as: Naropin

group NS; group US

ultrasound guidance DEVICE

In group US the sciatic nerve localization and needle guidance is realized using ultrasound.

group US

nerve stimulation technique DEVICE

In the group NS sciatic nerve localization and needle guidance is realized using nerve stimulation technique. However, ultrasound is used observing (Observer) the procedure, but blinded for the physician (Anesthetist) performing the block.

group NS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Helios Research Center: lead

MeSH Terms

Interventions

Midazolam; Prilocaine; Ropivacaine

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Dr. Ronald Seidel
• Organization: HELIOS-Kliniken Schwerin, Germany

ronald.seidel@helios-kliniken.de

0049 385 5204251

Study Officials

• Ronald Seidel, Dr. med.

  Klinik für Anästhesiologie und Intensivtherapie, Helios Kliniken Schwerin, Wismarsche Strasse 393-7, DE-19049 Schwerin

  PRINCIPAL INVESTIGATOR

• Georg Rehmert, Dr. med.

  Klinik für Anästhesiologie und Intensivtherapie, Helios Kliniken Schwerin, Wismarsche Strasse 393-7, DE-19049 Schwerin

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.med.Ronald Seidel

Study Record Dates

• First Submitted: July 16, 2012
• First Posted: July 18, 2012
• Study Start: November 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: September 1, 2012
• Last Updated: November 1, 2013
• Results First Posted: November 1, 2013

Record last verified: 2013-08