Postoperative Pain
Conditions
Keywords
ultrasonography, peripheral nerve block, peripheral nerve stimulation
Brief summary
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.
Detailed description
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.
Interventions
DEVICEUltrasound imaging
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
Sponsors
Halyard Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients having elective orthopedic surgery who are candidates for CPNB as part of their management program for postoperative pain * Age \>18 * Able to give consent
Exclusion criteria
* Morbid obesity (BMI\> 40) * Uncooperative or having psychological or linguistic difficulties * Previous damage to the nerve or plexus * Significant comorbidities which the primary investigator feels would limit the quality and collection of data * Allergy to local anesthetic agents including ropivacaine, bupivacaine and lidocaine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complications of Peripheral Nerve Block | Preoperative through 3 days post operative | Adverse events related to performance of peripheral nerve catheter placement for continuous infusion of local anesthetic |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| USPNB ultrasound imaging guided peripheral nerve block | 1,324 |
| NSPNB Stimulator guided nerve block | 497 |
| Total | 1,821 |
Baseline characteristics
| Characteristic | NSPNB | USPNB | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 12 Participants | 12 Participants |
| Age, Categorical >=65 years | 191 Participants | 469 Participants | 660 Participants |
| Age, Categorical Between 18 and 65 years | 306 Participants | 843 Participants | 1149 Participants |
| Age, Continuous | 57.7 years STANDARD_DEVIATION 17.2 | 57.1 years STANDARD_DEVIATION 16.4 | 57.3 years STANDARD_DEVIATION 16.6 |
| Region of Enrollment United States | 497 participants | 1324 participants | 1821 participants |
| Sex: Female, Male Female | 214 Participants | 649 Participants | 863 Participants |
| Sex: Female, Male Male | 283 Participants | 675 Participants | 958 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 7 / 1,324 | 14 / 497 |
| serious Total, serious adverse events | 0 / 1,324 | 0 / 497 |
Outcome results
Primary
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
Population: Intent to treat (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| USPNB | Complications of Peripheral Nerve Block | 7 participants |
| NSPNB | Complications of Peripheral Nerve Block | 14 participants |
Comparison: Null hypothesis: There is no difference in reported complications associated with the placement of continuous peripheral nerve block catheters between ultrasound imaging guided placement and nerve stimulator guided placement.p-value: <0.05t-test, 2 sided