Postoperative PainNCT07326774
Effect of Ultrasound-Guided Quadro-Iliac Plane Block on Postoperative Analgesia After Lumbar Spinal Surgery
An observational study of Postoperative Pain and Lumbar Spine Surgery, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain, Lumbar Spine Surgery, Postoperative Analgesia
- What is being tested?
- QIPB and LAI
- Type of treatment
- Injection or infusion
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jan 2026to 22 Oct 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients aged 18-65 years with ASA physical status I-III and body mass index <35 kg/m² scheduled for elective posterior lumbar segmental instrumentation surgery under general anesthesia. All participants provide written informed consent prior to enrollment.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Fatih Sultan Mehmet Training and Research Hospital
Istanbul, Istanbul, 34752
About this study
Official title: 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.
Read the 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.
- Being tested
- QIPB, LAI
- Keywords
- Quadro-Iliac Plane Block, QIPB, Ultrasound-Guided Regional Anesthesia, Lumbar Spinal Surgery, Postoperative Analgesia, Patient-Controlled Analgesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QIPBOther
Quadro-Iliac Plane Block using local anesthetic.
LAIOther
The surgeon will perform local anesthetic infiltration (LAI) of the incision site.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: QIPB | |
| 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. Receives: Other: LAI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity
Postoperative pain intensity assessed using the Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst imaginable pain.
Measured: Within the first 24 hours after surgery
Secondary outcomes (4)
Total Opioid Consumption
Total amount of tramadol consumption administered via intravenous patient-controlled analgesia during the first 24 hours postoperatively.
Measured: Within the first 24 hours after surgery
Requirement for Rescue Analgesia
Need for additional rescue analgesic medication during the first 24 hours postoperatively.
Measured: Within the first 24 hours after surgery
Postoperative Nausea and Vomiting
Incidence of postoperative nausea and vomiting during the first 24 hours after surgery.
Measured: Within the first 24 hours after surgery
Patient Satisfaction With Pain Management
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.
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start5 Jan 2026
- Primary completion22 Oct 2026
- Study completion22 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Acar Değer, Fatih Sultan Mehmet Training and Research Hospital
- Investigators
- Oznur Demiroluk, Assoc. Prof., Principal investigator, Fatih Sultan Mehmet Training and Research Hospital, Istanbul, Türkiye
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07326774
- Sponsor's protocol ID
- 2025/397
- Status last verified
- Feb 2026
- First submitted
- 26 Dec 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared, as data sharing was not planned at the time of study design and is not included in the ethical approval.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Ultrasound-Guided Quadro-Iliac Plane Block on Postoperative Analgesia in Patients Undergoing Lumbar Spinal Surgery
- ClinicalTrials.gov ID
- NCT07326774
- Acronym / sponsor ID
- 2025/397
- Keywords
- Quadro-Iliac Plane Block, QIPB, Ultrasound-Guided Regional Anesthesia, Lumbar Spinal Surgery, Postoperative Analgesia, Patient-Controlled Analgesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- 22 Oct 2026 (actual)
- Study completion
- 22 Oct 2026 (actual)
- First posted
- 8 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCA + QIPB Group | – | Other: QIPBPatients 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. |
| PCA + LAI Group | – | Other: LAIPatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients aged 18-65 years with ASA physical status I-III and body mass index <35 kg/m² scheduled for elective posterior lumbar segmental instrumentation surgery under general anesthesia. All participants provide written informed consent prior to enrollment.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QIPBQuadro-Iliac Plane Block using local anesthetic. | Other | PCA + QIPB Group |
| LAIThe surgeon will perform local anesthetic infiltration (LAI) of the incision site. | Other | PCA + LAI Group |
Primary outcome
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.
4 secondary outcomes
Total Opioid Consumption
Time frame: Within the first 24 hours after surgery
Requirement for Rescue Analgesia
Time frame: Within the first 24 hours after surgery
Postoperative Nausea and Vomiting
Time frame: Within the first 24 hours after surgery
Patient Satisfaction With Pain Management
Time frame: 24 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared, as data sharing was not planned at the time of study design and is not included in the ethical approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oznur Demiroluk, Assoc. Prof. principal investigator
Fatih Sultan Mehmet Training and Research Hospital, Istanbul, Türkiye
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain and Lumbar Spine Surgery, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Intensity (time frame: Within the first 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.