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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group US | Active Comparator | Ultrasound guided block : 20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients) |
|
| group NS | Active Comparator | Nerve stimulation technique: 20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Success Rate Without Supplementation | After injection of local anesthetic a waiting period of 30-60 minutes was defined before completing a failed block.
| 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.
| later than 30-60 minutes after injection of the local anesthetic |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
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Adult patients were informed and included in the study in the anesthesiology outpatient clinic as part of normal pre-operative preparation. Using a computer-generated list of random numbers, patients were randomly allocated to either the nerve stimulation group (NS group, n=125) or the ultrasound group (US group, n=125).
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| ID | Title | Description |
|---|---|---|
| FG000 | Group US | Ultrasound guided block : 20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients) |
| FG001 | Group NS | Nerve stimulation technique: 20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group US | Ultrasound guided block : 20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients) |
| BG001 | Group NS | Nerve stimulation technique: 20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Success Rate Without Supplementation | After injection of local anesthetic a waiting period of 30-60 minutes was defined before completing a failed block.
| 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. | Posted | Number | participants | within 30-60 minutes after injection of the local anesthetic |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group US | Ultrasound guided block : 20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| polyradicular sensomotor impairment | Nervous system disorders | Systematic Assessment | With one patient in the group NS, the insufficient block was supplemented by spinal anesthesia, which was initially free of complications. In the postoperative course polyradicular sensomotor impairment developed around lumbosacral plexus (L4-S1). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Paresthesia | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ronald Seidel | HELIOS-Kliniken Schwerin, Germany | 0049 385 5204251 | ronald.seidel@helios-kliniken.de |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| D011318 | Prilocaine |
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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|
| Prilocaine 1% | Drug | 20ml Prilocaine 1% for distal sciatic nerve block (30ml Prilocaine 1% in outpatients) |
|
|
| Ropivacaine 0.75% | Drug | 10ml Ropivacaine 0.75% for distal sciatic nerve block (not in outpatients) |
|
|
| Prilocaine 1% | Drug | 10ml Prilocaine 1% for saphenous nerve block |
|
|
| ultrasound guidance | Device | In group US the sciatic nerve localization and needle guidance is realized using ultrasound. |
|
| 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. |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Group US |
Ultrasound guided block : 20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients) |
| OG001 | Group NS | Nerve stimulation technique: 20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients) |
|
|
|
| Primary | Time Until Readiness for Surgery (Minutes) | Posted | Mean | 95% Confidence Interval | minutes | within 60 minutes after injection of the local anesthetic |
|
|
|
|
| Primary | Success Rate With Supplementation | After injection of local anesthetic a waiting period of 30-60 minutes was defined before completing a failed block.
| Posted | Number | participants | later than 30-60 minutes after injection of the local anesthetic |
|
|
|
|
| 0 |
| 125 |
| 66 |
| 125 |
| EG001 | Group NS | Nerve stimulation technique: 20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients) | 1 | 125 | 24 | 125 |
|
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| D006571 | Heterocyclic Compounds |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |