Pain, PostoperativeNCT02440542
Popliteal Nerve Block for Postoperative Pain Control in Ankle and Hindfoot Reconstruction
An observational study of Pain, Postoperative, run by University of Tennessee.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Survey of outcomes following popliteal nerve block
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2015to May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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)
About this study
Official title: 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.
- Conditions
- Pain, Postoperative
- Being tested
- Survey of outcomes following popliteal nerve block
- Keywords
- Nerve block, Ankle, Talus, Pain, Postoperative
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey of outcomes following popliteal nerve blockOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Survey of outcomes following popliteal nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain rating
Measured by VAS
Measured: Postoperative- through 12 weeks
Secondary outcomes (3)
Narcotic intake
Measured by data from hospital medical record and patient questionnaire
Measured: Postoperative- through 12 weeks
Hospital length of stay
Measured by data from hospital medical record
Measured: Postoperative- through day of hospital discharge (discharge same day of surgery to approximately 3 days postop)
Patient satisfaction
Measured by patient questionnaire
Measured: Postoperative- through first surgical follow-up (up to 3 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startMay 2015
- Primary completionMay 2018
- Study completionMay 2018
Why it stopped: Study enrollment not initiated due to institutional delays
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jesse F Doty, MD, Principal investigator, University of Tennessee College of Medicine Chattanooga/Erlanger Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02440542
- Sponsor's protocol ID
- 15-025
- Status last verified
- Nov 2018
- First submitted
- 20 Apr 2015
- Last updated
- 29 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Popliteal Nerve Block for Postoperative Pain Control in Patients Undergoing Ankle and Hindfoot Reconstruction About the Talus
- ClinicalTrials.gov ID
- NCT02440542
- Acronym / sponsor ID
- 15-025
- Conditions
- Pain, Postoperative
- Keywords
- Nerve block, Ankle, Talus, Pain, Postoperative
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study enrollment not initiated due to institutional delays
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 12 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Postoperative Popliteal nerve block | – | Other: Survey of outcomes following popliteal nerve blockAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survey of outcomes following popliteal nerve blockPatients 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. | Other | Postoperative Popliteal nerve block |
Primary outcome
Pain rating
Time frame: Postoperative- through 12 weeks
Measured by VAS
3 secondary outcomes
Narcotic intake
Time frame: 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)
Patient satisfaction
Time frame: Postoperative- through first surgical follow-up (up to 3 weeks)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jesse F Doty, MD principal investigator
University of Tennessee College of Medicine Chattanooga/Erlanger Health System
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Postoperative, run by University of Tennessee.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain rating (time frame: Postoperative- through 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2018.