NCT04575688 - Periarticular Injection Versus Popliteal Block | Crick | Crick

Periarticular Injection Versus Popliteal Block

Phase 4Enrolling By InvitationNCT04575688

Campbell Clinic100 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Foot Surgery Ankle Surgery

Interventions

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

BupivicaineDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

A

Germantown, Tennessee, United States

Outcomes

Primary Outcomes

Visual Analog Score

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

Time frame: Postoperative hour 3

Evidence of motor block

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

Time frame: Postoperative hour 3

Visual Analog Score

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

Time frame: Postoperative hour 6

Visual Analog Score

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

Time frame: Postoperative hour 12

Visual Analog Score

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

Time frame: Postoperative hour 24

Visual Analog Score

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

Time frame: Postoperative hour 36

Visual Analog Score

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

Time frame: Postoperative hour 48

Visual Analog Score

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

Time frame: Postoperative hour 72

Data from ClinicalTrials.gov

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Secondary Outcomes

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.

Time frame: Immediately after surgery

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.

Time frame: Postoperative week 2

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.

Time frame: Postoperative week two

Pill count

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

Time frame: Postoperative week 2

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.

Time frame: Postoperative week 2

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.

Time frame: Postoperative week 6

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.

Time frame: Postoperative week 6

Pill count

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

Time frame: Postoperative week 6

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.

Time frame: Postoperative week 6

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.

Time frame: Postoperative week 12

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.

Time frame: Postoperative week 12

Pill count

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

Time frame: Postoperative week 12

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.

Time frame: Postoperative week 12