NCT06199999

Erector Spinae Plane Block vs Local Infiltration Following Fusion Surgery

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: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Rashmi Mueller · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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 Infiltration Anesthesia). This group receives general anesthesia and surgical procedure will take place as planned. Prior to being awakened, the area of procedure will be infiltrated using local anesthetic (LIA). * Group GA. This group receives general anesthesia (GA) only and surgical procedure will follow standard conditions. Pre-procedure activities for all groups will include survey evaluations. If the surveys demonstrate pre-procedure cognitive deficits, the subject's participation will cease. All subjects who do not display deficits will complete baseline evaluations that include social history, pain medication history and rate their pain (scored from 1 to 10). The subjects will be randomized to a treatment group. Once the subject is asleep and prior to incision, laboratory blood tests will be drawn and again approximately 24 hours after the subject is received into the recovery unit. Following their surgical procedure, pain control for all subjects will be at the discretion of their primary care team. However, as part of the study, the amount of opioid medications required to control their pain and their pain rating score for the first 72 hours post surgery will be collected from the subject's medical record unless discharged from the hospital before this cutoff time. On post-operative days when subject remains in the hospital facility, repeat survey evaluations will be carried out and during the first 7 days of the subject's hospital stay and unanticipated event will be recorded from the subject's medical record.

Conditions

• Postoperative Delirium
• Pain, Postoperative
• Degenerative Disc Disease

Interventions

Type	Name	Description
PROCEDURE	Erector Spinae Block	General anesthesia with Erector Spinae Plane Block
PROCEDURE	Local infiltration with local anesthetic	General anesthesia with local infiltration of local anesthetic:

Timeline

• Start date: 2024-05-15
• Primary completion: 2025-04-29
• Completion: 2025-04-29
• First posted: 2024-01-10
• Last updated: 2026-02-13

Locations

1 site across 1 country: United States