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Enrolling by Invitation

NCT Number: NCT04575688

Periarticular Injection Versus Popliteal Block

This study aims to determine the effectiveness and safety of two standard of care perioperative procedures for controlling pain following ankle and hindfoot osteotomy or fusion or ankle fracture repair.

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Key information

Conditions

Foot Surgery Ankle Surgery

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

A

Germantown, Tennessee, 38138, United States

About this study

This is a prospective, randomized, controlled research study of two perioperative standards of care for managing post operative pain. The first standard of care procedure is the periarticular injection; the second is the popiteal block.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ankle or hindfoot osteotomy or ankle fracture repair
  • Surgery scheduled at Campbell Surgery Center (1410 Brierbrook Road, Germantown, TN 38138)
  • 18-80 years of age
  • ASA I-III with medical clearances as needed
  • Fluent ub verbal and written English
  • Willing and able to comply with study instruction and commit to all follow-up visits for theduration of the study
  • Willing and able to provide written consent

Exclusion criteria

  • Diagnosed with chronic pain syndrome
  • History of allergic reactions to lidocaine, marcaine, Experal, bupivicaine, or other injectable anesthetic agents
  • Injury associated with workers' compensation
  • Surgery to be performed at a hospital
  • Diagnosed with peripheral neuropathy
  • Hbg A1C is > 7 mg/dl in diabetic patients only
  • Long term (chronic) preoperative narcotic usage

Treatment and study plan

Exparel

Drug

Exparel will be administered by periarticular injection to patients undergoing hindfoot osteotomy or fusion, ankle osteotomy or fusion, or ankle fracture repair.

Other names: Periarticular Injection

bupivicaine

Drug

Bupivicaine will be administered by popliteal block to patients undergoing hindfoot osteotomy or fusion, ankle osteotomy or fusion, or ankle fracture repair.

Other names: Peripheral Nerve Injection

Primary outcomes

  1. Visual Analog Score

    Time frame: Postoperative hour 3

    Patient reported pain score from zero to ten where zero is no pain and ten is the most pain

  2. Evidence of motor block

    Time frame: Postoperative hour 3

    Patient reported yes/no answer to survey question: "Are you able to wiggle your toes?"

  3. Visual Analog Score

    Time frame: Postoperative hour 6

    Patient reported pain score from zero to ten where zero is no pain and ten is the most pain

  4. Visual Analog Score

    Time frame: Postoperative hour 12

    Patient reported pain score from zero to ten where zero is no pain and ten is the most pain

  5. Visual Analog Score

    Time frame: Postoperative hour 24

    Patient reported pain score from zero to ten where zero is no pain and ten is the most pain

  6. Visual Analog Score

    Time frame: Postoperative hour 36

    Patient reported pain score from zero to ten where zero is no pain and ten is the most pain

  7. Visual Analog Score

    Time frame: Postoperative hour 48

    Patient reported pain score from zero to ten where zero is no pain and ten is the most pain

  8. Visual Analog Score

    Time frame: Postoperative hour 72

    Patient reported pain score from zero to ten where zero is no pain and ten is the most pain

  9. Visual Analog Score

    Time frame: Postoperative week 2

    Patient reported pain score from zero to ten where zero is no pain and ten is the most pain

  10. Visual Analog Score

    Time frame: Postoperative week 4-6

    Patient reported pain score from zero to ten where zero is no pain and ten is the most pain

  11. Visual Analog Score

    Time frame: Postoperative week 12

    Patient reported pain score from zero to ten where zero is no pain and ten is the most pain

Secondary outcomes

  1. Document pain medication prescribed immediately after surgery

    Time frame: Immediately after surgery

    Pain medication prescribed immediately after the surgery will be documented in the research record. This is a descriptive data point to capture the incidence of narcotics prescribed immediately after surgery, to include opiate name, dose, and number of pills prescribed.

  2. Satisfaction with pain control: survey question

    Time frame: Postoperative week 2

    Patient reported 7-point Likert scale answer to survey question: "How satisfied are you with your pain control?" 1 = very dissatisfied, 2 = dissatisfied, 3 = moderately dissatisfied, 4 = neutral, 5 = moderately satisfied, 6 = satisfied, 7 = very satisfied.

  3. Neuralgia symptoms: survey question

    Time frame: Postoperative week two

    Patient reported yes/no answer to survey question: "Have you had any signs of neuralgia, such as persistent numbness, tingling, or increased sensitivity in your foot or ankle that you feel is not at the surgical location?" 1 = yes, I have had signs of neuralgia; 2 = no, I have not had signs of neuralgia.

  4. Pill count

    Time frame: Postoperative week 2

    Patient reported fill-in-the-blank answer to survey question: "Total number of pain pills taken during this time."

  5. Document pain medication prescribed at postoperative week 2

    Time frame: Postoperative week 2

    Pain medication prescribed at postoperative week 2 will be documented in the research record. This is a descriptive data point to capture the incidence of narcotics prescribed at postoperative week 2, to include opiate name, dose, and number of pills prescribed.

  6. Satisfaction with pain control: survey question

    Time frame: Postoperative week 6

    Patient reported 7-point Likert scale answer to survey question: "How satisfied are you with your pain control?" Patient reported 7-point Likert scale answer to survey question: "How satisfied are you with your pain control?" 1 = very dissatisfied, 2 = dissatisfied, 3 = moderately dissatisfied, 4 = neutral, 5 = moderately satisfied, 6 = satisfied, 7 = very satisfied.

  7. Neuralgia symptoms: survey question

    Time frame: Postoperative week 6

    Patient reported yes/no answer to survey question: "Have you had any signs of neuralgia, such as persistent numbness, tingling, or increased sensitivity in your foot or ankle that you feel is not at the surgical location?" 1 = yes, I have had signs of neuralgia; 2 = no, I have not had signs of neuralgia.

  8. Pill count

    Time frame: Postoperative week 6

    Patient reported fill-in-the-blank answer to survey question: "Total number of pain pills taken during this time."

  9. Document pain medication prescribed at postoperative week 6

    Time frame: Postoperative week 6

    Pain medication prescribed at postoperative week 6 will be documented in the research record. This is a descriptive data point to capture the incidence of narcotics prescribed at postoperative week 6, to include opiate name, dose, and number of pills prescribed.

  10. Satisfaction with pain control: survey question

    Time frame: Postoperative week 12

    Patient reported 7-point Likert scale answer to survey question: "How satisfied are you with your pain control?" Patient reported 7-point Likert scale answer to survey question: "How satisfied are you with your pain control?" 1 = very dissatisfied, 2 = dissatisfied, 3 = moderately dissatisfied, 4 = neutral, 5 = moderately satisfied, 6 = satisfied, 7 = very satisfied.

  11. Neuralgia symptoms: survey question

    Time frame: Postoperative week 12

    Patient reported yes/no answer to survey question: "Have you had any signs of neuralgia, such as persistent numbness, tingling, or increased sensitivity in your foot or ankle that you feel is not at the surgical location?" 1 = yes, I have had signs of neuralgia; 2 = no, I have not had signs of neuralgia.

  12. Pill count

    Time frame: Postoperative week 12

    Patient reported fill-in-the-blank answer to survey question: "Total number of pain pills taken during this time."

  13. Document pain medication prescribed at postoperative week 12

    Time frame: Postoperative week 12

    Pain medication prescribed at postoperative week 12 will be documented in the research record. This is a descriptive data point to capture the incidence of narcotics prescribed at postoperative week 12, to include opiate name, dose, and number of pills prescribed.

Sponsors and collaborators

Lead sponsor

Campbell Clinic

Other

Registry information

Official study title

A Randomized Controlled Trial Comparing a Periarticular Injection to a Popliteal Block for Pain Control in Ankle/Hindfoot Osteotomy or Fusion and Ankle Fractures

Acronym: PvP

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Oct 5, 2020
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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