A Randomized Controlled Trial Comparing the Effect of Erector Spinae Plane Blocks Versus High Volume Local Infiltration Analgesia on Pain, Inflammation and Cognitive Outcomes Following Thoraco-Lumbar Fusion Surgery

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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 induction of anesthesia but prior to the start of surgery and subjects who will receive a high volume of local anesthetic infiltration at the end of the procedure before emergence from anesthesia. The control group of subjects will undergo spinal surgery with general anesthesia but without any regional anesthesia. Outcome measurements include evaluation of serum inflammatory markers, pain scores, opioid usage and standardized evidence-based assessment methodologies.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
United States
Iowa
University of Iowa Health Care Medical Center
RECRUITING
Iowa City
Contact Information
Primary
Rashmi Mueller, MD
rashmi-mueller@uiowa.edu
+1 319 356 2633
Time Frame
Start Date: 2024-05-15
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 120
Treatments
No_intervention: Group GA: General anesthesia only
This group receives general anesthesia only and surgical procedure will follow standard conditions.
Active_comparator: Group ESP: Erector Spinae Block
This group receives general anesthesia with regional pain block (Erector Spinae Block) prior to incision.
Active_comparator: Group LIA: Local Infiltration
This group receives general anesthesia and surgical procedure will take place as planned. Prior to being awakened, the area of procedure will be infiltrated.
Sponsors
Leads: Rashmi Mueller

This content was sourced from clinicaltrials.gov