Human Experimental Models of Pain (HEMP)
NCT07549490
Acute Pain, Aortic Stenosis, Subvalvular
Bethesda, Maryland, United States
View Trial DetailsNCT Number: NCT07694180
The aim of this study is to evaluate the postoperative analgesic efficacy of the Serratus Posterior Superior Intercostal Plane Block (SPSIP block) in patients undergoing Anterior Cervical Discectomy and Fusion (ACDF) surgery and to compare the outcomes with those of patients who do not receive regional anesthesia.
Trial opening soon.
Get Notified18 year–70 year
All sexes
Observational
Cervical disc disorders may lead to various signs and symptoms, including neck pain, radicular pain in the upper extremities, sensory disturbances, motor weakness, and functional impairment. Anterior cervical discectomy and fusion (ACDF) is a widely accepted surgical procedure for the treatment of cervical disc herniation and other degenerative cervical spine disorders. However, postoperative pain remains a significant concern and may adversely affect recovery and patient comfort.
A multimodal analgesic approach is commonly preferred for postoperative pain management following cervical spine surgery. The incorporation of regional anesthesia techniques may reduce opioid consumption and opioid-related adverse effects while facilitating earlier mobilization, shorter hospital stay, and improved patient satisfaction.
In patients undergoing ACDF surgery, the Serratus Posterior Superior Intercostal Plane Block (SPSIPB) has emerged as a promising regional anesthesia technique for postoperative pain control. This study aims to evaluate the postoperative analgesic efficacy of SPSIPB and compare postoperative outcomes between patients receiving SPSIPB and those managed without regional anesthesia.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 24 hours
Time frame: 24 hours
In the postoperative period, patients will be given opioids according to their pain density with a patient-controlled device, and the daily Morphine consumption in Patient Controlled Analgesia device will be collected and compared between groups.
Time frame: 24 hours
Changes in the Numerical Rating Scale (NRS) will be recorded at rest and during movement. The participant's baseline NRS will be recorded, followed by measurements before and after neuraxial positioning and up to 24 hours post-surgery. The NRS is a unidimensional measure of pain intensity in adults. It is a segmented numerical version of the Visual Analog Scale (VAS) where the participant selects a whole number (0-10) that best represents the intensity of their pain. The 11-point numerical scale ranges from '0' representing one end of the pain spectrum (e.g. 'no pain') to '10' representing the other end (e.g. 'worst imaginable pain').
Time frame: 24 hours after surgery
Postoperative Quality of Recovery 15 in Turkish scale. The QoR-15 (Quality of Recovery-15) questionnaire is a simple and practical tool used to assess postoperative recovery. It consists of 15 items, each scored on a numeric scale from 0 to 10, resulting in a total score ranging from 0 to 150. Based on the total score, postoperative recovery is categorized as follows: 136-150: Excellent recovery 122-135: Good recovery 90-121: Moderate recovery 0-89: Poor recovery
Time frame: 24 hours
Postoperative nausea and vomiting (PONV): During follow-up, patients who experience nausea or vomiting will be evaluated using a verbal descriptive PONV scale (0=None, 1=Mild nausea, 2=Moderate nausea, 3=Single episode of vomiting, 4=More than one episode of vomiting).
Contact information is provided by the study sponsor or research team.
Samsun University
Other
Postoperative Outcomes of Regional Blocks Performed in Cervical Disc Surgery: A Prospective Observational Study
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