Popliteal Nerve Block for Postoperative Pain Control in Ankle and Hindfoot Reconstruction

November 27, 2018 updated by: University of Tennessee

Popliteal Nerve Block for Postoperative Pain Control in Patients Undergoing Ankle and Hindfoot Reconstruction About the Talus

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population will be patients undergoing ankle or hindfoot reconstruction about the talus (ankle arthrodesis, subtalar arthrodesis, or ankle arthroplasty) who will be receiving a sciatic nerve block in the popliteal region while in the PACU, following surgery. Patients will be identified as potential subjects from within the practices of two fellowship-trained foot and ankle orthopaedic surgeons. Patients will be enrolled in the study by Informed Consent

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Postoperative Popliteal nerve block
All patients in the cohort are receiving a postoperative popliteal nerve block as part of their surgical plan. Outcomes including length of stay, Visual Analog Scale Scores, narcotic intake, and patient satisfaction will be collected as the 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain rating
Time Frame: Postoperative- through 12 weeks
Measured by VAS
Postoperative- through 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Narcotic intake
Time Frame: Postoperative- through 12 weeks
Measured by data from hospital medical record and patient questionnaire
Postoperative- through 12 weeks
Hospital length of stay
Time Frame: Postoperative- through day of hospital discharge (discharge same day of surgery to approximately 3 days postop)
Measured by data from hospital medical record
Postoperative- through day of hospital discharge (discharge same day of surgery to approximately 3 days postop)
Patient satisfaction
Time Frame: Postoperative- through first surgical follow-up (up to 3 weeks)
Measured by patient questionnaire
Postoperative- through first surgical follow-up (up to 3 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Tennessee

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

April 20, 2015

First Submitted That Met QC Criteria

May 6, 2015

First Posted (Estimate)

May 12, 2015

Study Record Updates

Last Update Posted (Actual)

November 29, 2018

Last Update Submitted That Met QC Criteria

November 27, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-025

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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