University of Iowa Health Care Medical Center
Iowa City, Iowa, 52242, United States
NCT Number: NCT06199999
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.
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Notify Me18 year–80 year
All sexes
Interventional
Phase 2
Iowa City, Iowa, 52242, United States
Treatment arms include:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for all groups:
Exclusion criteria
for all groups:
General anesthesia with Erector Spinae Plane Block
General anesthesia with local infiltration of local anesthetic:
Time frame: Change from pre-operation score to 1 day after surgery date
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.
Time frame: Change from pre-operation score to 1 day after surgery date
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.
Time frame: Change from pre-operation score to 3 days after surgery date
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.
Rashmi Mueller
Other
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
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