Status:
ACTIVE_NOT_RECRUITING
Erector Spinae Plane Block vs Local Infiltration Following Fusion Surgery
Lead Sponsor:
Rashmi Mueller
Conditions:
Postoperative Delirium
Pain, Postoperative
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The proposed intervention will examine two alternative methods for postoperative pain control. Two treatment arms of this study will include subjects who receive an erector spinae block (ESP) after in...
Detailed Description
Treatment arms include: * Group ESP (Erector Spinae Plane). This group receives general anesthesia with ESP (Erector Spinae Block) regional pain block prior to incision. * Group LIA (Local Infiltrati...
Eligibility Criteria
Inclusion
- Inclusion Criteria for all groups:
- Age: Greater than 18 years but less than 80
- Surgical procedure: 1 to 2 level thoraco-lumbar fusion between T8 and S2; non-emergent surgery
- Opioid naive (less than 6 oxycodone/day or 30 mg oxycodone equivalent)
- No contraindication to local anesthetics or regional procedures.
- Exclusion Criteria for all groups:
- Emergency surgery
- Allergy to study medications
- BMI less than 20 or greater than 50
- Major liver or kidney dysfunction or other pre-existing major organ dysfunction
- Revision surgery
- Opioid tolerant (60 mg morphine equivalents/day for 1 week) or narcotic dependence (opioid intake morphine equivalent greater than10 mg/day for more than 3 months)
- Other sources of chronic pain (e.g. fibromyalgia)
- Patients with associated significant central nervous system (CNS) or respiratory disease (home oxygen use)
- Pre-operative neurological deficits
- Co-existing hematological disorders or deranged coagulation parameters
- Significant psychiatric illnesses that impedes the subject's ability to provide informed consent
- Language barrier
- Vulnerable population (e.g. prisoners)
- Pregnant females
- History of recent myocardial infarction
- History of recent cardiac stent procedure (within 3 months)
- Cardiac ejection fraction \< 30%
Exclusion
Key Trial Info
Start Date :
May 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06199999
Start Date
May 15 2024
End Date
December 30 2026
Last Update
December 2 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Iowa Health Care Medical Center
Iowa City, Iowa, United States, 52242