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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02440542
Other study ID # 15-025
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date May 2015
Est. completion date May 2018

Study information

Verified date November 2018
Source University of Tennessee
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to evaluate outcomes of popliteal nerve blocks for postoperative pain control in patients undergoing ankle and hindfoot reconstruction surgeries. The following outcomes will be analyzed: length of hospital stay, level of pain control, pain medication use, complications, and patient satisfaction.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date May 2018
Est. primary completion date May 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adult patients = 18 years old

- Patients undergoing ankle, subtalar, pantalar, triple, or tibiotalocalcaneal arthrodesis (CPT codes 27870, 28715, 28725, or 28740)

- Patients undergoing total ankle arthroplasty (CPT code 27702)

- Patients with a preoperative surgical plan to receive a popliteal nerve block during the postoperative period

- Patients whom can be reasonably expected to understand and comply with patient-reported postoperative data collection and surveys

Exclusion Criteria:

- Patients undergoing an ankle or hindfoot reconstruction procedure whom are medically ineligible to receive a safe popliteal nerve block (i.e. patients with neuropathy)

- Patients with documented substance abuse (i.e. history of narcotic abuse could confound pain outcomes)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Survey of outcomes following popliteal nerve block
Patients will be instructed to complete journals of pain and narcotic use until postoperative day 10. On first follow-up visit, patients will complete a patient satisfaction survey. VAS Pain scores and pain medication use will be collected up to 12 weeks postoperatively.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Tennessee

Outcome

Type Measure Description Time frame Safety issue
Primary Pain rating Measured by VAS Postoperative- through 12 weeks
Secondary Narcotic intake Measured by data from hospital medical record and patient questionnaire Postoperative- through 12 weeks
Secondary Hospital length of stay Measured by data from hospital medical record Postoperative- through day of hospital discharge (discharge same day of surgery to approximately 3 days postop)
Secondary Patient satisfaction Measured by patient questionnaire Postoperative- through first surgical follow-up (up to 3 weeks)
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