An interventional study of Ultrasound imaging and Peripheral nerve stimulator in Postoperative Pain, sponsored by Halyard Health. Completed at 16 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-02.
Sponsored by Halyard Health · Not applicable, Interventional, and Treatment
This two tiered study is a multi-center, open label, surveillance study of the use of continuous nerve blocks with the ON-Q® C-bloc and either nerve stimulator or ultrasound guided continuous nerve block techniques. This study was developed to investigate specific aspects of complication rates related to continuous nerve block techniques in patients undergoing orthopedic surgical procedures.
Continuous peripheral nerve block techniques require the placement of catheters near target peripheral nerves. The placement of these catheters is guided by either ultrasound visualization, nerve stimulation or a combination of the two.
This surveillance study was designed to look at the rates of catheter placement related complications with the two techniques.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 1,821 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Halyard Health is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Ultrasound imaging guided peripheral nerve block
Device: Ultrasound imaging
Peripheral nerve stimulator guided peripheral nerve block catheter placement for continuous infusion of local anesthetic
Device: Peripheral nerve stimulator
Ultrasound guided techniques for placement of peripheral nerve block catheters for continuous infusion of local anesthetic
either stimulating needle or stimulating catheter used for placement of catheter for continuous infusion of local anesthetic
Complications of Peripheral Nerve Block
Adverse events related to performance of peripheral nerve catheter placement for continuous infusion of local anesthetic
Time frame: Preoperative through 3 days post operative
| Milestone | USPNB | NSPNB |
|---|---|---|
| Started | 1324 | 497 |
| Completed | 1324 | 497 |
| Not completed | 0 | 0 |
Adverse events related to performance of peripheral nerve catheter placement for continuous infusion of local anesthetic
| participants | USPNB | NSPNB |
|---|---|---|
| Complications of Peripheral Nerve Block | 7 | 14 |
Collected over 7 days postoperative. Non-serious events are listed at a 0.1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| USPNB | — | 0/1,324 (0%) | 7/1,324 (0.5%) |
| NSPNB | — | 0/497 (0%) | 14/497 (2.8%) |
| Event | USPNB | NSPNB |
|---|---|---|
| VASCULAR PUNCTUREVascular disorders | 4/1324 | 8/497 |
| motor blockNervous system disorders | 1/1324 | 4/497 |
| InfectionInfections and infestations | 2/1324 | 2/497 |
| Age, Categorical(Participants) | USPNB | NSPNB | Total |
|---|---|---|---|
| <=18 years | 12 | 0 | 12 |
| Between 18 and 65 years | 843 | 306 | 1149 |
| >=65 years | 469 | 191 | 660 |
| Age, Continuous(years) | USPNB | NSPNB | Total |
|---|---|---|---|
| Mean | 57.1 ± 16.4 | 57.7 ± 17.2 | 57.3 ± 16.6 |
| Sex: Female, Male(Participants) | USPNB | NSPNB | Total |
|---|---|---|---|
| Female | 649 | 214 | 863 |
| Male | 675 | 283 | 958 |
| Region of Enrollment(participants) | USPNB | NSPNB | Total |
|---|---|---|---|
| United States | 1324 | 497 | 1821 |
This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.
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