Trial · NCT01643616
Ultrasound Guided Distal Sciatic Nerve Block - a Comparison With Nerve Stimulator Technique
NCT01643616, Not applicable, Completed, Helios Research Center; results first posted 2013-11-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Ultrasound Guided Distal Sciatic Nerve Block - a Comparison With Nerve Stimulator Technique. Trials, record NCT01643616. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01643616
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ultrasound Guided Distal Sciatic Nerve Block - a Comparison With Nerve Stimulator Technique
- NCT number
- NCT01643616
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 250 participants, actual
- Lead sponsor
- Helios Research Center
- Conditions
- Other Surgical Procedures
- Interventions
- midazolam, Prilocaine 1%, Ropivacaine 0.75%, Prilocaine 1%, ultrasound guidance, nerve stimulation technique
- First posted
- 2012-07-18
- Last updated
- 2013-11-01
- Results first posted
- 2013-11-01
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Success Rate Without Supplementation | 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 |
| Primary | Time Until Readiness for Surgery (Minutes) | within 60 minutes after injection of the local anesthetic | |
| Primary | Success Rate With Supplementation | 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 |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Success Rate Without Supplementation | within 30-60 minutes after injection of the local anesthetic | 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. | participants | NUMBER |
| PRIMARY | Time Until Readiness for Surgery (Minutes) | within 60 minutes after injection of the local anesthetic | minutes | MEAN | |
| PRIMARY | Success Rate With Supplementation | later than 30-60 minutes after injection of the local anesthetic | participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Success Rate Without Supplementation | Group US | 112 | participants | ||
| Success Rate Without Supplementation | Group NS | 73 | participants | ||
| Time Until Readiness for Surgery (Minutes) | Group US | 15.1 | 95% Confidence Interval 13.6 to 16.5 | minutes | |
| Time Until Readiness for Surgery (Minutes) | Group NS | 28 | 95% Confidence Interval 24.9 to 31.1 | minutes | |
| Success Rate With Supplementation | Group US | 116 | participants | ||
| Success Rate With Supplementation | Group NS | 85 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group US | 125 | |
| Overall Study | STARTED | Group NS | 125 | |
| Overall Study | COMPLETED | Group US | 125 | |
| Overall Study | COMPLETED | Group NS | 125 | |
| Overall Study | NOT COMPLETED | Group US | 0 | |
| Overall Study | NOT COMPLETED | Group NS | 0 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Paresthesia | Nervous system disorders | Group US | 66 | 125 | 66 |
| other | Paresthesia | Nervous system disorders | Group NS | 24 | 125 | 24 |
| serious | polyradicular sensomotor impairment | Nervous system disorders | Group US | 0 | 125 | 0 |
| serious | polyradicular sensomotor impairment | Nervous system disorders | Group NS | 1 | 125 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group US | ||
| Total, all-cause mortality | Group NS | ||
| Total, other adverse events | Group US | 66 | 125 |
| Total, other adverse events | Group NS | 24 | 125 |
| Total, serious adverse events | Group US | 0 | 125 |
| Total, serious adverse events | Group NS | 1 | 125 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Group US vs Group NS: Success Rate With Supplementation | Trial comparisons |
| Group US vs Group NS: Success Rate Without Supplementation | Trial comparisons |
| Group US vs Group NS: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01643616
GET https://conductscience.org/api/trials/v1/NCT01643616/registered