Erector Spinae Plane Block vs Local Infiltration Following Fusion Surgery

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 80 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria for all groups: 1. Age: Greater than 18 years but less than 80. 2. Surgical procedure: 1 to 2 level thoraco-lumbar fusion between T8 and S2; non-emergent surgery. 3. Opioid naive (less than 6 oxycodone/day or 30 mg oxycodone equivalent) 4. No contraindication to local anesthetics or regional procedures. Exclusion Criteria for all groups: 1. Emergency surgery. 2. Allergy to study medications. 3. BMI less than 20 or greater than 50. 4. Major liver or kidney dysfunction or other pre-existing major organ dysfunction. 5. Revision surgery. 6. 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) 7. Other sources of chronic pain (e.g. fibromyalgia) 8. Patients with associated significant central nervous system (CNS) or respiratory disease (home oxygen use) 9. Pre-operative neurological deficits. 10. Co-existing hematological disorders or deranged coagulation parameters. 11. Significant psychiatric illnesses that impedes the subject's ability to provide informed consent. 12. Language barrier. 13. Vulnerable population (e.g. prisoners) 14. Pregnant females. 15. History of recent myocardial infarction. 16. History of recent cardiac stent procedure (within 3 months) 17. Cardiac ejection fraction < 30%

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06199999
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Rashmi Mueller
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Rashmi Mueller, MD
Principal Investigator Affiliation	University of Iowa
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Postoperative Delirium, Pain, Postoperative, Degenerative Disc Disease

Additional Details

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.

Arms & Interventions

Arms

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.

Interventions

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:

Contact a Trial Team

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Iowa City, Iowa

Status

Recruiting

Address

University of Iowa Health Care Medical Center

Iowa City, Iowa, 52242

Site Contact

Rashmi Mueller, MD

[email protected]

319-356-2633

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