Clinical trial NCT04575688: Periarticular Injection Versus Popliteal Block
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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE4
Conditions: Foot Surgery
Ankle Surgery
Lead sponsor: Campbell Clinic
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual Analog Score
timeFrame: Postoperative hour 3
measure: Evidence of motor block
timeFrame: Postoperative hour 3
measure: Visual Analog Score
timeFrame: Postoperative hour 6
measure: Visual Analog Score
timeFrame: Postoperative hour 12
measure: Visual Analog Score
timeFrame: Postoperative hour 24
measure: Visual Analog Score
timeFrame: Postoperative hour 36
measure: Visual Analog Score
timeFrame: Postoperative hour 48
measure: Visual Analog Score
timeFrame: Postoperative hour 72
measure: Visual Analog Score
timeFrame: Postoperative week 2
measure: Visual Analog Score
timeFrame: Postoperative week 4-6
measure: Visual Analog Score
timeFrame: Postoperative week 12
Secondary outcomes:
measure: Document pain medication prescribed immediately after surgery
timeFrame: Immediately after surgery
measure: Satisfaction with pain control: survey question
timeFrame: Postoperative week 2
measure: Neuralgia symptoms: survey question
timeFrame: Postoperative week two
measure: Pill count
timeFrame: Postoperative week 2
measure: Document pain medication prescribed at postoperative week 2
timeFrame: Postoperative week 2
measure: Satisfaction with pain control: survey question
timeFrame: Postoperative week 6
measure: Neuralgia symptoms: survey question
timeFrame: Postoperative week 6
measure: Pill count
timeFrame: Postoperative week 6
measure: Document pain medication prescribed at postoperative week 6
timeFrame: Postoperative week 6
measure: Satisfaction with pain control: survey question
timeFrame: Postoperative week 12
measure: Neuralgia symptoms: survey question
timeFrame: Postoperative week 12
measure: Pill count
timeFrame: Postoperative week 12
measure: Document pain medication prescribed at postoperative week 12
timeFrame: Postoperative week 12
Other outcomes:
Locations:
city: Germantown
country: United States
facility: A
state: Tennessee
Study officials:
affiliation: Campbell Clinic
name: Garnett A Murphy, MD
role: PRINCIPAL_INVESTIGATOR
References: