Postoperative Outcomes of Regional Blocks in Cervical Disc Surgery
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorSamsun University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged between 18 and 70 years.
American Society of Anesthesiologists (ASA) physical status I, II, or III.
Patients scheduled for elective anterior cervical discectomy and fusion (ACDF) surgery under general anesthesia.
Patients who provide written informed consent and agree to participate in the study.
Disqualifiers
Patients with a history of bleeding diathesis or those receiving anticoagulant therapy.
Patients with a known allergy or hypersensitivity to local anesthetics or opioid medications.
Patients with infection at the planned block site.
Patients with a history of previous cervical spine surgery.
Trial population
The study population will consist of adult patients aged 18-70 years with ASA physical status I-III who are scheduled to undergo elective anterior cervical discectomy and fusion (ACDF) surgery under general anesthesia at Samsun City Hospital. Eligible patients who provide written informed consent and meet the study inclusion criteria will be enrolled consecutively during the study period
Trial design
Design model
Other
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
66 Participants
are grouped into 2 trial groupsGroup A: Group-SPSİPB
Group B: Group-Control
Trial outcomes
Primary outcomes
1
Opioid consumption
Time frame
24 hours2
1. Opioid consumption
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 hoursSecondary outcomes
1
2. Perioperative pain intensity
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 hours2
Quality of recovery 15 scale
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 after surgery3
Postoperative nausea and vomiting
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).
Time frame
24 hoursLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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