Periarticular Injection Versus Popliteal Block

Foot Surgery Clinical Trial

— PvP  

Official 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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04575688
• Other study ID #: 19-06453-FB
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: July 13, 2021
• Est. completion date: July 2025

Study information

• Verified date: October 2023
• Source: Campbell Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: July 2025
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Ankle Surgery
• Foot Surgery

Intervention

Drug:
• Exparel
Exparel will be administered by periarticular injection to patients undergoing hindfoot osteotomy or fusion, ankle osteotomy or fusion, or ankle fracture repair.
• Bupivicaine
Bupivicaine will be administered by popliteal block to patients undergoing hindfoot osteotomy or fusion, ankle osteotomy or fusion, or ankle fracture repair.

Locations

Country	Name	City	State
United States	A	Germantown	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Campbell Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Score	Patient reported pain score from zero to ten where zero is no pain and ten is the most pain	Postoperative hour 3
Primary	Evidence of motor block	Patient reported yes/no answer to survey question: "Are you able to wiggle your toes?"	Postoperative hour 3
Primary	Visual Analog Score	Patient reported pain score from zero to ten where zero is no pain and ten is the most pain	Postoperative hour 6
Primary	Visual Analog Score	Patient reported pain score from zero to ten where zero is no pain and ten is the most pain	Postoperative hour 12
Primary	Visual Analog Score	Patient reported pain score from zero to ten where zero is no pain and ten is the most pain	Postoperative hour 24
Primary	Visual Analog Score	Patient reported pain score from zero to ten where zero is no pain and ten is the most pain	Postoperative hour 36
Primary	Visual Analog Score	Patient reported pain score from zero to ten where zero is no pain and ten is the most pain	Postoperative hour 48
Primary	Visual Analog Score	Patient reported pain score from zero to ten where zero is no pain and ten is the most pain	Postoperative hour 72
Primary	Visual Analog Score	Patient reported pain score from zero to ten where zero is no pain and ten is the most pain	Postoperative week 2
Primary	Visual Analog Score	Patient reported pain score from zero to ten where zero is no pain and ten is the most pain	Postoperative week 4-6
Primary	Visual Analog Score	Patient reported pain score from zero to ten where zero is no pain and ten is the most pain	Postoperative week 12
Secondary	Document pain medication prescribed 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.	Immediately after surgery
Secondary	Satisfaction with pain control: survey question	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.	Postoperative week 2
Secondary	Neuralgia symptoms: survey question	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.	Postoperative week two
Secondary	Pill count	Patient reported fill-in-the-blank answer to survey question: "Total number of pain pills taken during this time."	Postoperative week 2
Secondary	Document pain medication prescribed at 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.	Postoperative week 2
Secondary	Satisfaction with pain control: survey question	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.	Postoperative week 6
Secondary	Neuralgia symptoms: survey question	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.	Postoperative week 6
Secondary	Pill count	Patient reported fill-in-the-blank answer to survey question: "Total number of pain pills taken during this time."	Postoperative week 6
Secondary	Document pain medication prescribed at 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.	Postoperative week 6
Secondary	Satisfaction with pain control: survey question	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.	Postoperative week 12
Secondary	Neuralgia symptoms: survey question	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.	Postoperative week 12
Secondary	Pill count	Patient reported fill-in-the-blank answer to survey question: "Total number of pain pills taken during this time."	Postoperative week 12
Secondary	Document pain medication prescribed at 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.	Postoperative week 12