Other Surgical ProceduresNCT01643616

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

A study testing midazolam, Prilocaine 1% and Ropivacaine 0.75% in people with Other Surgical Procedures, run by Helios Research Center.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Other Surgical Procedures
What is being tested?: midazolam, Prilocaine 1% and Ropivacaine 0.75%
Type of treatment: Pill or oral medicine, Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 250 participants
Where: No sites listed yet
Study dates: Nov 2010to Sep 2012
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

About this study

Official title: Ultrasound Guided Distal Sciatic Nerve Block - a Randomised Comparison With Nerve Stimulator Technique

Read the 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.

Conditions: Other Surgical Procedures
Being tested: midazolam, Prilocaine 1%, Ropivacaine 0.75%, ultrasound guidance, nerve stimulation technique
Keywords: Sciatic Nerve, Ultrasound, Anesthesia, Regional, Orthopedic Surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

midazolamDrug
Also called Dormicum
Prior to performing the regional anesthesia the investigators administered midazolam as a premedication by mouth (3,75-7,5mg) or intravenously (2-3mg).
Prilocaine 1%Drug
Also called Xylonest
20ml Prilocaine 1% for distal sciatic nerve block (30ml Prilocaine 1% in outpatients)
Ropivacaine 0.75%Drug
Also called Naropin
10ml Ropivacaine 0.75% for distal sciatic nerve block (not in outpatients)
Prilocaine 1%Drug
Also called Xylonest
10ml Prilocaine 1% for saphenous nerve block
ultrasound guidanceDevice
In group US the sciatic nerve localization and needle guidance is realized using ultrasound.
nerve stimulation techniqueDevice
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.

Study groups in NCT01643616
Study group	Role	What they receive
group US	Active comparator	Ultrasound guided block : 20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients) Receives: 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) Receives: Drug: midazolam; Drug: Prilocaine 1%; Drug: Ropivacaine 0.75%; Device: nerve stimulation technique

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: within 30-60 minutes after injection of the local anesthetic
Time Until Readiness for Surgery (Minutes)
Measured: 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
Measured: later than 30-60 minutes after injection of the local anesthetic

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2010Sep 2012

First posted18 Jul 2012 (estimated)
Study startNov 2010
Primary completionJun 2012
Study completionSep 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Other Surgical ProceduresStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 250 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01643616
Sponsor's protocol ID: HV 2010 003
Status last verified: Aug 2013
First submitted: 16 Jul 2012
Last updated: 1 Nov 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 1 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ultrasound Guided Distal Sciatic Nerve Block - a Randomised Comparison With Nerve Stimulator Technique
ClinicalTrials.gov ID: NCT01643616
Acronym / sponsor ID: HV 2010 003
Conditions: Other Surgical Procedures
Keywords: Sciatic Nerve, Ultrasound, Anesthesia, Regional, Orthopedic Surgery
Study type: Interventional
Recruitment status: Completed
Enrolment: 250 participants (actual)
Lead sponsor: Helios Research CenterUniversity, hospital or other
Study start: Nov 2010
Primary completion: Jun 2012 (actual)
Study completion: Sep 2012 (actual)
First posted: 18 Jul 2012 (estimated)
Results: Posted 1 Nov 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
group US	Active comparator	Drug: midazolam, Drug: Prilocaine 1%, Drug: Ropivacaine 0.75%, Device: ultrasound guidanceUltrasound guided block : 20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)
group NS	Active comparator	Drug: midazolam, Drug: Prilocaine 1%, Drug: Ropivacaine 0.75%, Device: nerve stimulation techniqueNerve stimulation technique: 20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (8 listed)

severe coagulopathy
systemic inflammatory response
ASA-risk-groups > III (American Society of Anesthesiologists)
drug allergy: local anesthetics
pregnancy, lactation period

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
midazolamAlso: DormicumPrior to performing the regional anesthesia the investigators administered midazolam as a premedication by mouth (3,75-7,5mg) or intravenously (2-3mg).	Drug	group NS, group US
Prilocaine 1%Also: Xylonest20ml Prilocaine 1% for distal sciatic nerve block (30ml Prilocaine 1% in outpatients)	Drug	group NS, group US
Ropivacaine 0.75%Also: Naropin10ml Ropivacaine 0.75% for distal sciatic nerve block (not in outpatients)	Drug	group NS, group US
Prilocaine 1%Also: Xylonest10ml Prilocaine 1% for saphenous nerve block	Drug	group NS, group US
ultrasound guidanceIn group US the sciatic nerve localization and needle guidance is realized using ultrasound.	Device	group US
nerve stimulation techniqueIn 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.	Device	group NS

Primary outcome

Success Rate Without Supplementation
Time frame: within 30-60 minutes after injection of the local anesthetic
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
Time Until Readiness for Surgery (Minutes)
Time frame: within 60 minutes after injection of the local anesthetic
Success Rate With Supplementation
Time frame: later than 30-60 minutes after injection of the local anesthetic
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

Results and safety

Results posted to the registry on 1 Nov 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group US	125	125
Group NS	125	125

Primary outcome: Success Rate Without Supplementation

Time frame: within 30-60 minutes after injection of the local anesthetic. Number. Unit: participants

Measure	Group US n = 118	Group NS n = 118
Value	112	73

Group US vs Group NS: Percentage Difference: 33, p < 0.05, Fisher Exact

Population analysed: In the NS group two investigators were necessary in order to realize the blinded study protocol. For personnel reasons this was not possible in every case and led to deviations from the randomization protocol for seven patients in each group. These patients were excluded from the analysis.

Primary outcome: Time Until Readiness for Surgery (Minutes)

Time frame: within 60 minutes after injection of the local anesthetic. Mean (95% Confidence Interval). Unit: minutes

Measure	Group US n = 118	Group NS n = 118
Value	15.1 (13.6 to 16.5)	28 (24.9 to 31.1)

Group US vs Group NS: Mean Difference (Final Values): 22.9 (95% CI 13.6 to 31.1), p < 0.05, Log Rank

Primary outcome: Success Rate With Supplementation

Time frame: later than 30-60 minutes after injection of the local anesthetic. Number. Unit: participants

Measure	Group US n = 118	Group NS n = 118
Value	116	85

Group US vs Group NS: Percentage Difference: 26.2, p = 0.05, Fisher Exact

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group US	0 of 125 (0%)	66 of 125 (52.8%)	Not reported
Group NS	1 of 125 (0.8%)	24 of 125 (19.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ronald Seidel, Dr. med. principal investigator

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

Georg Rehmert, Dr. med. study director

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

Questions about this trial

What is this clinical trial studying?

A study testing midazolam, Prilocaine 1% and Ropivacaine 0.75% in people with Other Surgical Procedures, run by Helios Research Center.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Success Rate Without Supplementation (time frame: within 30-60 minutes after injection of the local anesthetic). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01643616.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2013.