- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07326774
Effect of Ultrasound-Guided Quadro-Iliac Plane Block on Postoperative Analgesia After Lumbar Spinal Surgery
Evaluation of the Effect of Ultrasound-Guided Quadro-Iliac Plane Block on Postoperative Analgesia in Patients Undergoing Lumbar Spinal Surgery
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Elif Acar Deger, Dr.
- Phone Number: +905069435510
- Email: drelifacardeger@gmail.com
Study Locations
-
-
Istanbul
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Istanbul, Istanbul, Turkey (Türkiye), 34752
- Recruiting
- Fatih Sultan Mehmet Training and Research Hospital
-
Contact:
- Elif Acar Deger, MD
- Phone Number: +90 506 943 55 10
- Email: drelifacardeger@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients aged between 18 and 65 years
- American Society of Anesthesiologists (ASA) physical status I-III
- Body mass index (BMI) <35 kg/m²
- Scheduled for elective posterior lumbar spinal instrumentation surgery under general anesthesia
Exclusion Criteria:
- Refusal to participate in the study
- Emergency surgery
- Local infection or hematoma at the block application site
- Previous surgery at the block application site
- Presence of coagulopathy
- Known allergy or toxicity to local anesthetics
- History of hematological, renal, or hepatic disease, or advanced respiratory or cardiac failure
- Chronic analgesic use, chronic alcohol consumption, or substance abuse
- Inability to speak Turkish or presence of language/communication barriers
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
PCA + QIPB Group
Patients who receive standard postoperative intravenous patient-controlled analgesia (PCA) with tramadol in combination with ultrasound-guided Quadro-Iliac Plane Block (QIPB) as part of routine clinical care following lumbar spinal surgery.
|
Quadro-Iliac Plane Block using local anesthetic.
|
|
PCA + LAI Group
Patients who receive standard postoperative intravenous patient-controlled analgesia (PCA) with tramadol alone without the addition of any regional analgesic block following lumbar spinal surgery.
In addition, the surgeon will perform local anesthetic infiltration (LAI) of the incision site as part of the routine analgesia protocol.
|
The surgeon will perform local anesthetic infiltration (LAI) of the incision site.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Pain Intensity
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.
|
Within the first 24 hours after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total Opioid Consumption
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.
|
Within the first 24 hours after surgery
|
|
Requirement for Rescue Analgesia
Time Frame: Within the first 24 hours after surgery
|
Need for additional rescue analgesic medication during the first 24 hours postoperatively.
|
Within the first 24 hours after surgery
|
|
Postoperative Nausea and Vomiting
Time Frame: Within the first 24 hours after surgery
|
Incidence of postoperative nausea and vomiting during the first 24 hours after surgery.
|
Within the first 24 hours after surgery
|
|
Patient Satisfaction With Pain Management
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.
|
24 hours after surgery
|
Collaborators and Investigators
Investigators
- Principal Investigator: Oznur Demiroluk, Assoc. Prof., Fatih Sultan Mehmet Training and Research Hospital, Istanbul, Türkiye
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025/397
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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