Erector Spinae Plane Block vs Local Infiltration Following Fusion Surgery

NCT06199999 | Completed Phase 2

• 1 other identifier: 202201643
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Degenerative Disc Disease; Postoperative Delirium; Pain, Postoperative

Outcome Measures

Primary Outcomes (2)

• Comparison of Quality of Recovery (QoR-15) Scores Between Treatment Groups

  The Quality of Recovery-15 (QoR-15) is a patient reported assessment aimed to validate the patients recovery following surgical intervention. The subject is asked to provide a quantitative number to a series of questions. The answers are rated on a scale from 0 to 10, where 0 = none of the time and 10 = all of the time. The scores for all of the questions are summed and comparison between the treatment groups will be assessed.

  Change from pre-operation score to 1 day after surgery date

• Quantitate the Change in Delirium Symptoms; Pre- to post-operative day 1

  Potential new onset of delirium following surgical procedure will be assessed using the standardized 3D CAM ASSESSMENT (3-Minute Diagnostic Interview for the Confusion Assessment Method (CAM)). The subject is asked a series of questions and their responses are recorded. This structured mental status assessment is designed to detect the presence or absence of delirium. "The CAM algorithm is considered positive if the following features are present: Feature 1) Acute onset or fluctuating course and Feature 2) Inattention and either Feature 3) Disorganized thinking or Feature 4) Altered level of consciousness." Comparison between the treatment groups will be assessed and the presence of post-operative delirium reported. Reference: Marcantonio et al., (PMID: 25329203) and training manual.

  Change from pre-operation score to 1 day after surgery date

Secondary Outcomes (1)

• Quantitate the Change in Delirium Symptoms; Pre- to post-operative day 3

  Change from pre-operation score to 3 days after surgery date

Study Arms (3)

Group GA: General anesthesia only

NO INTERVENTION

This group receives general anesthesia only and surgical procedure will follow standard conditions.

Group ESP: Erector Spinae Block

ACTIVE COMPARATOR

This group receives general anesthesia with regional pain block (Erector Spinae Block) prior to incision.

Procedure: Erector Spinae Block

Group LIA: Local Infiltration

ACTIVE COMPARATOR

This group receives general anesthesia and surgical procedure will take place as planned. Prior to being awakened, the area of procedure will be infiltrated.

Procedure: Local infiltration with local anesthetic

Interventions

Erector Spinae Block PROCEDURE

General anesthesia with Erector Spinae Plane Block

Group ESP: Erector Spinae Block

Local infiltration with local anesthetic PROCEDURE

General anesthesia with local infiltration of local anesthetic:

Group LIA: Local Infiltration

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rashmi Mueller: lead

Study Sites (1)

University of Iowa Health Care Medical Center

Iowa City, Iowa, 52242, United States

Location

Related Publications (26)

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MeSH Terms

Conditions

Emergence Delirium; Pain, Postoperative; Intervertebral Disc Degeneration

Interventions

Anesthetics, Local

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Pain; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Rashmi Mueller, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: December 28, 2023
• First Posted: January 10, 2024
• Study Start: May 15, 2024
• Primary Completion: April 29, 2025
• Study Completion: April 29, 2025
• Last Updated: February 13, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Individual participant data (IPD) will be available for sharing immediately after publication and ending 5 years following article publication.
• Access Criteria: Individual participant data (IPD) will be accessible to researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal.

Locations

US (1)