Fatih Sultan Mehmet Training and Research Hospital
Istanbul, 34752, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07326774
This prospective observational study aims to evaluate the effect of ultrasound-guided Quadro-Iliac Plane Block (QIPB) on postoperative analgesia in patients undergoing lumbar spinal surgery. Lumbar spinal procedures are commonly associated with significant postoperative pain, which may impair early mobilization and increase opioid consumption. In routine clinical practice, QIPB is increasingly used as part of multimodal analgesia to improve pain control and reduce opioid-related adverse effects.
Adult patients scheduled for elective lumbar spinal surgery under general anesthesia will be followed according to routine clinical care. Postoperative analgesia will be managed with intravenous patient-controlled analgesia (PCA) using tramadol, with or without the addition of ultrasound-guided QIPB, based on the preference of the attending anesthesiologist. No intervention or treatment assignment will be performed by the investigators.
Postoperative pain scores at rest and during movement, opioid consumption, need for rescue analgesics, incidence of nausea and vomiting, and patient satisfaction will be recorded during the first 24 hours after surgery. The findings of this study are expected to provide further clinical evidence regarding the effectiveness of QIPB as part of multimodal analgesia in lumbar spinal surgery.
Interested in participating?
Request Info18 year–65 year
All sexes
Observational
Istanbul, 34752, Turkey (Türkiye)
Location status: Recruiting
This is a single-center, prospective observational cohort study conducted in patients undergoing elective lumbar spinal surgery under general anesthesia. The study is designed to assess the effects of ultrasound-guided Quadro-Iliac Plane Block (QIPB) on postoperative analgesia when used as part of routine multimodal pain management.
Eligible patients aged 18-65 years with American Society of Anesthesiologists (ASA) physical status I-III and a body mass index below 35 kg/m² will be included after providing written informed consent. All patients will receive standardized general anesthesia and postoperative intravenous patient-controlled analgesia (PCA) with tramadol as part of routine care. The decision to perform QIPB will be made by the attending anesthesiologist according to clinical judgment and routine practice, without any intervention or assignment by the research team.
Ultrasound-guided QIPB, when applied, will be performed bilaterally under sterile conditions in the prone position at the end of surgery. In patients who do not receive QIPB, the surgeon will perform local anesthetic infiltration (LAI) of the incision site as part of routine postoperative analgesia. Patients will be observed in two cohorts: those receiving PCA with LAI and those receiving PCA with QIPB.
Postoperative outcomes will be assessed in the post-anesthesia care unit and at 1, 6, 12, and 24 hours postoperatively. Pain intensity will be evaluated using the Numeric Rating Scale (NRS) at rest and during movement. Secondary outcomes will include total opioid consumption, time to first rescue analgesic requirement, incidence of postoperative nausea and vomiting, sedation level, and patient satisfaction assessed using a 5-point Likert scale at 24 hours. Any block-related complications will also be recorded.
Data will be analyzed using appropriate statistical methods to compare postoperative analgesic outcomes between the two cohorts. This observational study aims to reflect real-world clinical practice and contribute to the growing evidence on the role of QIPB in postoperative pain management after lumbar spinal surgery.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Quadro-Iliac Plane Block using local anesthetic.
The surgeon will perform local anesthetic infiltration (LAI) of the incision site.
Time frame: Within the first 24 hours after surgery
Postoperative pain intensity assessed using the Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst imaginable pain.
Time frame: Within the first 24 hours after surgery
Total amount of tramadol consumption administered via intravenous patient-controlled analgesia during the first 24 hours postoperatively.
Time frame: Within the first 24 hours after surgery
Need for additional rescue analgesic medication during the first 24 hours postoperatively.
Time frame: Within the first 24 hours after surgery
Incidence of postoperative nausea and vomiting during the first 24 hours after surgery.
Time frame: 24 hours after surgery
Patient satisfaction with postoperative pain management was assessed at 24 hours after surgery using a 5-point Likert Satisfaction Scale (range: 1-5), where 1 = "not satisfied at all," 2 = "not satisfied," 3 = "neutral," 4 = "satisfied," and 5 = "very satisfied," with higher scores indicating greater patient satisfaction.
Contact information is provided by the study sponsor or research team.
Fatih Sultan Mehmet Training and Research Hospital
Other
Evaluation of the Effect of Ultrasound-Guided Quadro-Iliac Plane Block on Postoperative Analgesia in Patients Undergoing Lumbar Spinal Surgery
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07607262
Laparoscopic Cholecystectomy, Neurologic Manifestations
Sancaktepe, Istanbul, Turkey (Türkiye)
View Trial DetailsNCT07455565
Lumbar Spine Surgery, Neurologic Manifestations
Antalya, Turkey (Türkiye)
View Trial DetailsNCT07412522
Neurologic Manifestations, Pain
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT07073846
Agnosia, Morbid Obesity Requiring Bariatric Surgery
Mexico City, Mexico
View Trial Details